STANDARD BIDDING DOCUMENTS AND …documents.worldbank.org/curated/en/265171468764143374/...Conditions of Contract must be made through the Special Conditions of Contract. The Technical

STANDARD BIDDING DOCUMENTSAND TECHNICAL NOTE

20735Procurement of

Health Sector Goods

The World BankWashington, D.C.

May 2000

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STANDARD BIDDING DOCUMENTS

Procurement of HealthSector Goods

(Pharmaceuticals, Vaccines, and Condoms)

The World Bank

May 2000

iii

PREFACE

These Standard Bidding Documents (SBD) and its companion TechnicalNote (TN) have been prepared by the World Bank for use by borrowers and theirimplementing agencies in the procurement of pharmaceuticals, vaccines, andcondoms through international competitive bidding (ICB). For the purpose of thesedocuments, pharmaceuticals also include nutritional supplements and oral andinjectable hormonal forms of contraception. The procedures and practices presentedin these SBD have been developed through broad international experience and aremandatory for use in projects that are financed in whole or in part by the World Bankin accordance with the provisions of the latest edition of Guidelines: Procurementunder IBRD Loans and IDA Credits. The purpose of the TN is to provide backgroundinformation to the Bank's project staff and borrowers, about the complex issues inthe procurement of health sector goods and to help them make well-informeddecisions in each special situation.

As shown in the table below, these SBD contains two types of documents:those that must be used unchanged, and those that should be customizedspecifically for each procurement. An electronic version of these SBD is availableon disk from the Bank's project staff or the Bank's Procurement Policy and ServicesGroup Web site: http://www.worldbank.org/html/opr/procure/contents.html. This canbe used to customize the Invitation for Bids and Sections 11, V, VI, and VIl to meetthe requirements of the specific procurement. Sections 1, Ii, and IV, however, mustbe incorporated unchanged in the Bidding Documents.

The Sample Technical Specifications Section, as well as some specificprovisions of the Bid Data Sheet and Special Conditions of Contract, are applicableto pharmaceuticals, vaccines, and condoms. Care should be taken to ensure thatthese additional specific provisions are incorporated into the body of the BiddingDocument and that changes or additions made to one of the customized sectionsare reflected in the other customized sections when appropriate.

To be customized To be used unchanged

Invitation for Bids Section I Instructions to BiddersSection 11 Bid Data Sheet Section III Eligibility for theSection V Special Conditions of Provision of Goods,

Contract Works, and Services inSection VI Schedule of Bank-Financed

Requirements ProcurementSection VIl Technical Section IV General Conditions of

Specifications Contract

Section Vill Sample Forms(including the Form ofContract Agreement)

iv Preface

Additional Instructions to Bidders and the contract-specific details needed forthe bidding and evaluation process to be properly carried out must be made throughthe Bid Data Sheet only. With the Bank's no objection, amendments to the GeneralConditions of Contract must be made through the Special Conditions of Contract.The Technical Requirements section of the Bidding Documents should not be usedto modify any of the subjects covered by Sections 1, 111, or IV.

Clauses included in the Special Conditions of Contract of these SBD shouldbe modified as appropriate to reflect the specific needs of each procurement.Because such modifications prevail over the General Conditions of Contract, majorchanges should be avoided unless absolutely necessary. If, in the opinion of thePurchaser, the specific nature of a procurement justifies a change, it should consultwith the World Bank.

Some of the language presented in the Technical Specifications Section ofthese SBD, as well as certain Sample Forms (so identified), are also illustrative.Appropriate modifications should be made to match the requirements of a particularprocurement.

The following typographical conventions are used in these SBD.

* Standard SBD text is presented in a typeface such as used in this line! (serif roman).

. Explanatory text and notes are presented in a typeface such asthat used in this line and in the body of this Preface (sans serif).

* When parameters, options, instructions, and/or explanatorynotes appear directly within the standard text, they are enclosedwith square brackets, italicized, and the key parameter bolded.

For example:

"The authorized Procurement Agent is: [if applicable, specify:

identity of duly authorized Procurement Agent, otherwise

delete J

* When options appear within the text, they are enclosed withinsquare brackets and separated by the slash character "/'.

For example:

"The language of all correspondence and documents related to the bid

is [select: English /French /Spanish J."

[ ~~~~~~~~~~~~~~~~~~.._.. .. _.. .... ........... .......... ... . ......... ...... ........... .......... .............. ......... ... .......... . .... .......... ... ........... .................. ......... .............. ................. ................... ......... ........

Preface v

Specific details, such as the "name of the Purchaser" and "address for bidsubmission," should be furnished in the Invitation for Bids, in the Bid Data Sheet,and in the Special Conditions of Contract. The final documents should containneither blank spaces nor options.

Accordingly, all explanatory text (i.e., all text in sans serif type face) must beremoved from the final Bidding Documents. Also, all bracketed text must be eitherremoved, if not relevant to the specific procurement, or selected for inclusion in thefinal Bidding Documents. Where options are presented, one must be selected andthe final chosen text should be in standard roman typeface.

Footnotes that provide guidance and instruction to the Purchaser in preparingthe Bidding Documents should also be removed from the final draft. However, someSample Forms contain footnotes that provide instructions to bidders on how the formshould be prepared. These should remain in the final Bidding Documents.

These SBD and TN for the procurement of health sector goods have beenprepared through a close collaboration between the Procurement Policy andServices Group, Operational Core Services Network, and the Health Nutrition &Population, Human Development Network, with the support of various Bank staff.The significant contributions to these documents made by staff and consultants ofthe following institutions are gratefully acknowledged: WHO, UNICEF, UNFPA,MSH, and Crown Agents. Thanks are also due to a number of other stakeholders,such as representatives from the pharmaceutical industry and various NGOs fortheir comments on previous drafts of these documents.

The Bank welcomes any feedback or experiences from the use of theseBidding Documents from bidders and from others as well.

Procurement Policy and Services GroupOperational Core Services Network

The World Bank1818 H Street, N.W.

Washington, D.C. 20433U.S.A.

[email protected]://www.worldbank.org/html/opr/procure/contents.html

vii

CONTENTS

Invitation for Bids .............................................................. 1Notes on the Preparation of the Invitation for Bids (IFB) .....................................................2

Section I. Instructions to Bidders .............................................................. 7

Notes on the Instructions to Bidders (ITB) .............................................................. 8Table of Clauses .............................................................. 9

Section II. Bid Data Sheet ............................................................. 39

Notes on the Bid Data Sheet ............................................................. 40Pharmaceuticals ............................................................. 55Vaccines ............................................................. 57

Section III. Eligibility for the Provision of Goods, Works, and Services in Bank-Financed Procurement ............................................................. 59

Notes on the Eligibility Section ............................................................. 60

Section IV. General Conditions of Contract ............................................................. 63Notes on the General Conditions of Contract ............................................................. 64Table of Clauses ............................................................. 65

Section V. Special Conditions of Contract ............................................................. 81Notes on the Special Conditions of Contract ............................................................. 82Table of Clauses ............................................................. 83Pharmaceuticals ............................................................. 99Vaccines ............................................................. 101Condoms ............................................................. 103

Section VI. Schedule of Requirements ............................................................. 105Notes for Preparing the Schedule of Requirements ........................................................... 106

Section VII. Technical Specifications ............................................................. 107Notes for Preparing the Technical Specifications (Procurement Specific) ........................ 108Pharmaceuticals .............................................................. 111Vaccines .............................................................. 115Condoms ............................................................. 121

Section VIII. Sample Forms ............................................................. 125

Notes to the Purchaser on the Preparation of the Sample Forms ....................................... 126Notes to Bidders on the Preparation of Sample Forms ...................................................... 128Sample Forms ............................................................. 129

I

INVITATION FOR BIDS

2 Invitation for Bids

NOTES ON THE PREPARATION OF THE INVITATION FOR BIDS (IFB)

In accordance with the Guidelines: Procurement under IBRD Loans and IDACredits, dated January 1995, revised January and August 1996, September 1997,and January 1999, the Invitation for Bids (IFB) / Specific Procurement Notice (SPN)shall be issued (in the language of the Bidding Documents) as:

(a) an advertisement in at least one newspaper of general circulation inthe Purchaser's country and in the official gazette, if any;

(b) a letter addressed to interested Bidders who, following the publicationof the General Procurement Notice, have expressed interest in bidding for theHealth Sector Goods for which the Invitation for Bids (IFB) is issued; and

(c) optionally, Purchasers are encouraged to advertise the biddingopportunity for smaller contracts in the United Nations publicationDevelopment Business and/or a circular to consular or diplomaticrepresentatives of countries with potential bidders;

(d) and, for contracts valued at above 10 million USD equivalent, or asotherwise stipulated in the loan/credit or trade agreement, advertisements inDevelopment Business and Scrip.

The content of the Invitation for Bids should be consistent with the Bid DataSheet (BDS). In particular, the dates, times, and place for bid submission andopening and the amount required for bid security in the IFB must be carefullychecked to ensure consistency with the BDS. Also, the IFB could list keyqualification criteria required for prospective Bidders to be responsive, as officiallyspecified in the BDS (e.g., minimum financial capacity, the minimum number ofyears during which the prospective Bidder has manufactured and marketed similargoods).

Advertising inquiries about the UN Development Business publication can be directed to:

Development Business

United Nations, Room DC1-560 Telephone: 1-212-963-1515One United Nations Plaza Facsimile: 1-212-963-1318New York, NY 10017 USA Telex: 422311 UNUI

Advertisements can also be arranged through the World Bank, where Development Businessmaintains a local office:

Development Business, Room MC10-436 Telephone: 1-202-458-23971818 H Street, N.W. Facsimile: 1-202-522-3316Washington, D.C. 20433, USA

Invitation for Bids 3

Advertising inquiries about the magazine SCRIP can be directed to:

SCRIP-World Pharmaceutical News

18-20 Hill Rise Telephone: 44-208-332 8871Richmond Surrey, TW1 0 6UA Facsimile: 44-208-332 8999United Kingdom email: rachel~scrip.demon.co.uk


Invitation for Bids (IFB)

[insert: name of country]

[insert: name of project ]

[insert.: brief description of the Goods ]

[insert: loan /credit number]

[insert: IFB title]

[insert. IFB number]

1. This invitation for bids follows the general procurement notice for this project thatappeared in Development Business, issue no. [insert number] of [insert date].'

2. The [insert name of borrower] [has received/has applied for/intends to apply for] a[loanlcredit] from the [International Bank for Reconstruction andDevelopment/International Development Association] toward the cost of [insert nameofproject], and it intends to apply part of the proceeds of this [loan/credit] to paymentsunder the contract for [insert name/no. of contract].2

3. The [insert name of implementing agency] now invites sealed bids from eligible biddersfor [insert brief description of goods or works to be procured].4

4. Bidding will be conducted through the international competitive bidding proceduresspecified in the World Bank's Guidelines: Procurement under IBRD Loans and IDACredits, and is open to all bidders from eligible source countries as defined in theGuidelines. 5

5. Interested eligible bidders may obtain further information from [insert name of agency]and inspect the bidding documents at the address given below [state address at end ofdocument] from [insert office hours].6

6. A complete set of bidding documents in [insert name of language] may be purchasedby interested bidders on the submission of a written application to the address below[state address at the end of document] and upon payment of a nonrefundable fee'[insert amount in local currency] or in [insert amount in specified convertiblecurrency]. The method of payment will be [insert method ofpayment].8 The documentwill be sent by [insert delivery procedure].9

Invitation for Bids 5

7. Bids must be delivered to the address below [state address at the end of document] at orbefore [insert time and date]. All bids must be accompanied by a bid security of [insertamount in local currency or minimum percentage of bid price] or an equivalent amountin a freely convertible currency.'° Late bids will be rejected. Bids will be opened in thepresence of the bidders' representatives who choose to attend at the address below [stateaddress at end of document] at [insert time and date].

[ insert: name of office ]

[ insert: name of officer ]

[insert: postal address ] and/or

[ insert: street address ]

[insert: telephone number, indicate country and city code]

[ insert: facsimile or cable number or e-mail address ]


Footnotes to IFB

1. Day, month, year; for example, 31 January 1996.

2. [Insert if applicable]. This contract will be jointly financed by [insert name of cofinancingagency]. Bidding will be govemed by the World Bank's eligibility rules and procedures.

3. A brief description of the type(s) of goods or works should be provided, including quantities,location of project, and other information necessary to enable potential bidders to decidewhether or not to respond to the invitation. Bidding documents may require bidders tohave specific experience or capabilities; such restrictions should also be included in thisparagraph.

4. [Insert if applicable.] The delivery/construction period is [insert no. of days/months/years ordates].

5. Occasionally, contracts may be financed out of special funds that would further restricteligibility to a particular group of member countries. When this is the case, it should bementioned in this paragraph. Also indicate any margin of preference that may begranted as specified in the Loan or Credit Agreement and set forth in the biddingdocuments.

6. For example, 0900 to 1200 hours.

7. The fee, to defray printing and mailing/shipping costs, should be nominal.

8. For example, cashier's check, direct deposit to specified account number, etc.

9. The delivery procedure is usually airmail for overseas delivery and surface mail or courierfor local delivery. If urgency or security dictates, courier services may be required foroverseas delivery.

10. The amount of bid security should be stated as a fixed amount or as a minimumpercentage of the bid price. Alternatively, if a bid security is not required (often the case insupply contracts), the paragraph should so state.

11. The office for bid opening may not necessarily be the same as that for inspection orissuance of documents or for bid submission. If they differ, each address must appear atthe end of paragraph 7 and be numbered; as, for example, (1), (2), (3). The text in theparagraph would then refer to address (1), (2), etc. Only one office and its address may bespecified for submission of bids, and this location should be as close as possible to theplace where bids will be opened to shorten the time between bid submission and bidopening.

7

SECTION I. INSTRUCTIONS TO BIDDERS

8 Section 1. Instructions to Bidders

NOTES ON THE INSTRUCTIONS TO BIDDERS (ITB)

This section of the Bidding Documents provides the information necessary forBidders to prepare and submit responsive bids that meet the Purchaser'srequirements. The ITB describe the critical steps of bid submission, opening andevaluation, and the award of contract.

The ITB are to be used unchanged. Section 11, which consists of the BidData Sheet (BDS), is designed to include provisions that supplement what isincluded in the ITB and provide the Contract-specific details needed for the biddingand evaluation process to be properly carried out. The Bid Data Sheet is specific toeach procurement and must be filled in completely by the Purchaser.

Matters governing the performance of the Supplier, payments under theContract, and affecting the risks, rights, and obligations of the parties under theContract during actual performance are not included in the ITB, but rather.in theGeneral Conditions of Contract (Section IV) and/or the Special Conditions ofContract (Section V). Different sections of the Bidding Documents should notoverlap or duplicate the coverage of a particular topic, to avoid creating ambiguityand/or contradictions.

The ITB and BDS do not form part of the final Contract.

Section I. Instructions to Bidders 9

TABLE OF CLAUSES

A. Introduction ................................................. 111. Scope of Bid .112. Source of Funds .113. Fraud and Corruption .124. Eligibility .135. Eligible Goods and Services .146. Documents Establishing Eligibility of Goods and Services and Conformity to

Bidding Documents .157. Qualifications of the Bidder .168. One Bid per Bidder .179. Cost of Bidding .17

B. The Bidding Documents ................................................ 1710. Content of Bidding Documents ................................................ 1711. Clarification of Bidding Documents ................................................ 1812. Amendment of Bidding Documents ................................................ 18

C. Preparation of Bids ................................................ 1813. Language of Bid ................................................ 1814. Documents Constituting the Bid ................................................ 1915. Bid Form ................................................ 2016. Bid Prices ................................................ 2017. Currencies of Bid ................................................. 2318. Period of Validity of Bids ................................................ 2319. Bid Security ................................................ 2320. Alternative Proposals by Bidders ................................................ 2521. Format and Signing of Bid ................................................ 25

D. Submission of Bids ....... .......................................... 2522. Sealing and Marking of Bids ................................................ 2523. Deadline for Submission of Bids ................................................ 2624. Late Bids ................................................ 2625. Modification and Withdrawal of Bids ................................................ 26

E. Opening and Evaluation of Bids ................................................. 2726. Bid Opening ................................................ 2727. Clarification of Bids ................................................ 2828. Confidentiality ................................................ 2829. Examination of Bids and Determination of Responsiveness .................................... 2930. Correction of Errors ................................................ 3031. Conversion to Single Currency ................................................ 3032. Evaluation and Comparison of Bids ................................................ 3133. Domestic Preference ................................................ 34


F. Award of Contract ...................................................... 3534. Postqualification ...................................................... 3535. Award Criteria ...................................................... 3636. Purchaser's Right to Accept Any Bid and to Reject Any or All Bids ...................... 3637. Purchaser's Right to Vary Quantities at Time of Award .......................................... 3638. Notification of Award ...................................................... 3639. Signing of Contract ...................................................... 3740. Performance Security ...................................................... 37

Section 1. Instructions to Bidders 11

Instructions to Bidders

A. INTRODUCTION

1. Scope of Bid 1.1 The Purchaser, as specified in the Bid Data Sheet and in theSpecial Conditions of Contract (SCC), invites bids for thesupply of Goods (pharmaceuticals, vaccines, contraceptives,or nutritional supplements as specified in the Bid DataSheet) described in the Schedule of Requirements. Thename and identification number of the Contract is providedin the Bid Data Sheet and in the SCC.

1.2 Throughout these bidding documents, the terms "writing"means any handwritten, typewritten, or printedcommunication, including telex, cable, and facsimiletransmission, and "day" means calendar day. Singular alsomeans plural.

2. Source of Funds 2.1 The Borrower named in the Bid Data Sheet has applied foror received a loan or credit (as identified with the loan/creditnumber in the Bid Data Sheet and called a "loan" in theseBidding Documents) from the International Bank forReconstruction and Development or from the InternationalDevelopment Association (interchangeably called "theBank" in these Bidding Documents) equivalent to theamount in U.S. dollars indicated in the Bid Data Sheettoward the cost of the Project named in the Bid Data Sheet.The Borrower intends to apply a part of the proceeds of thisloan to eligible payments under the Contract for which thesebidding documents are issued.

2.2 Payment by the Bank will be made only at the request of theBorrower and upon approval by the Bank in accordance withthe terms and conditions of the Loan Agreement, and will besubject in all respects to the terms and conditions of thatAgreement. The Loan Agreement prohibits a withdrawalfrom the loan account for the purpose of any payment topersons or entities, or for any import of Goods, if suchpayment or import, to the knowledge of the Bank, isprohibited by a decision of the United Nations SecurityCouncil taken under Chapter VII of the Charter of the UnitedNations. No party other than the Borrower shall derive anyrights from the Loan Agreement or have any claim to theloan proceeds.


3. Fraud and 3.1 It is the Bank's policy to require that Borrowers (includingCorruption beneficiaries of Bank loans), as well as

Bidders/Suppliers/Contractors under Bank-financedcontracts, observe the highest standard of ethics during theprocurement and execution of such Contracts. In pursuanceof this policy, the Bank:

(a) defines, for the purposes of this provision, the termsset forth below as follows:

(i) "corrupt practice" means the offering, giving,receiving, 'or soliciting of any thing of value toinfluence the action of a public official in theprocurement process or in Contract execution;and

(ii) "fraudulent practice" means a misrepresentationof facts in order to influence a procurementprocess or the execution of a Contract to thedetriment of the Borrower; it includes collusivepractices among bidders (prior to or after bidsubmission) designed to establish bid prices atartificial, noncompetitive levels and to deprivethe Borrower of the benefits of free and opencompetition.

(b) will not accept a Borrower's proposal for award if itdetermines that the bidder recommended for award hasengaged in corrupt or fraudulent practices incompeting for the Contract in question.

(c) will declare a firm ineligible, either indefinitely or fora stated period of time, to be awarded a Bank-financedContract if it at any time determines that the firm hasengaged in corrupt or fraudulent practices incompeting for, or in executing, a Bank-financedcontract.

3.2 Furthermore, bidders shall be aware of the provision statedin Sub-Clauses 5.4 and 23.1 (d) of the General Conditionsof Contract.

3.3 In pursuance of the policy defined in ITB Sub-Clause 3.1,the Bank will cancel the portion of the loan allocated to aContract for Goods or works if it at any time determines thatcorrupt or fraudulent practices were engaged in by therepresentatives of the Borrower or of a beneficiary of the


loan during the procurement or the execution of thatContract, without the Borrower having taken timely andappropriate action satisfactory to the Bank to remedy thesituation.

4. Eligibility 4.1 Except as provided in ITB Sub-Clauses 4.2 and 4.3, thisbidding process is open to:

(a) those prequalified firms from eligible source countries,as defined in the edition specified by the Bid DataSheet of the Guidelines: Procurement under IBRDLoans and IDA Credits herein referred to as theProcurement Guidelines, where a prequalificationprocess has been undertaken for the Contract(s) forwhich these Bidding Documents have been issued, or

(b) all firms from eligible source countries, as defined inthe edition specified by the Bid Data Sheet of theProcurement Guidelines, where a prequalificationprocess has not been undertaken for the contract(s) forwhich these Bidding Documents have been issued.

The Bank maintains a list of countries from which Bidders,Goods, and Services are not eligible to participate inprocurement financed by the Bank. The list is regularlyupdated and can be obtained from the Public InformationCenter (PIC) of the World Bank. Joint ventures includingmembers from ineligible source countries or includingineligible firms shall not be permitted to bid.

4.2 Firms of a member country may be excluded from biddingif:

(a) either: (i) as a matter of law or official regulation, theBorrower's country prohibits commercial relationswith that country, provided that the Bank is satisfiedthat such exclusion does not preclude effectivecompetition for the supply of the Goods required; or(ii) by an act of compliance with a decision of theUnited Nations Security Council taken under ChapterVII of the Charter of the United Nations, theBorrower's country prohibits any import of Goodsfrom that country or any payments to persons orentities in that country.

(b) a firm has been engaged by (i) the Borrower or (ii)the Purchaser or (iii) a Purchasing Agent that has


been duly authorized to act on behalf of the Borroweror Purchaser to provide consulting services for thepreparation of the design, specifications, and otherdocuments to be used for the procurement of theGoods described in these Bidding Documents.

(c) government-owned enterprises in the Borrower'scountry may participate only if they can establish thatthey (i) are legally and financially autonomous and(ii) operate under commercial law. No dependentagency of the Borrower or Sub-Borrower under aBank-financed project shall be permitted to bid orsubmit a proposal for the procurement of Goodsunder the project.

4.3 A firm declared ineligible by the Bank in accordance withITB Sub-Clause 3.1 (c) shall be ineligible to bid for a Bank-financed contract during the period of time determined bythe Bank.

4.4 Pursuant to ITB Sub-Clause 14.1, the Bidder shall furnish,as part of its bid, documents establishing, to the Purchaser'ssatisfaction, the Bidder's eligibility to bid.

4.5 Bidders shall provide such evidence of their continuedeligibility satisfactory to the Purchaser as the Purchasershall reasonably request.

5. Eligible Goods 5.1 Funds from Bank loans are disbursed only on account ofand Services expenditures for the Goods and Services, provided by

nationals of, and produced in or supplied from, eligiblesource countries as defined in the edition of theProcurement Guidelines specified in the Bid Data Sheet.The Bank maintains a list of countries from which Bidders,Goods, and Services are not eligible to participate inprocurement financed by the Bank. The list is regularlyupdated and can be obtained from the Public InformationCenter of the World Bank. Goods are produced in a Bankmember country when they are mined, grown, ormanufactured in the territory of that country. Goodsproduced or Services supplied from a Bank member countrymay be excluded if that member country is subject to theconditions specified in ITB Sub-Clause 4.2 (a) (i) or (ii).


5.2 For purposes of this clause, the nationality of the bidder isdistinct from the country from where the Goods andServices are supplied.

5.3 For purposes of this clause, (a) the term "Goods" includesany Goods that are the subject of this Invitation for Bids and(b) the term "Services" includes related services such astransportation, insurance, commissioning, and training.

6. Documents 6.1 Pursuant to ITB Clause 14, the Bidder shall furnish, as partEstablishing of its bid, documents establishing, to the Purchaser'sEligibility of satisfaction, the eligibility of the Health Sector Goods andGoods and services to be supplied under the Contract.Services andConformity to 6.2 The documentary evidence of the eligibility of the GoodsBidding and Services shall consist of a statement in the PriceDocuments Schedule of the country of origin of the Goods and Services

offered that shall be confirmed by a certificate of originissued at the time of shipment.

6.3 The documentary evidence of conformity of the goods andservices to the Bidding Documents may be in the form ofliterature, drawings, and data and shall consist of:

(a) a detailed description of the essential techniical andperformance characteristics of the Goods;

(b) an item-by-item commentary on the Purchaser'sTechnical Specifications demonstrating substantialresponsiveness of the Goods and Services to thosespecifications, or a statement of deviations andexceptions to the provisions of the TechnicalSpecifications;

(c) any other procurement-specific documentationrequirement as stated in the Bid Data Sheet.

6.4 Unless the Bid Data Sheet stipulates otherwise, the Goodsto be supplied under the Contract shall be registered withthe relevant authority in the Purchaser's country. A Bidderwho has already registered its Goods by the time of biddingshould submit a copy of the Registration Certificate with itsbid. Otherwise, the successful Bidder, by the time ofContract signing, shall submit to the Purchaser either:

(a) a copy of the Registration Certificate of the Goods foruse in the Purchaser's country.


OR, if such Registration Certificate has not yet beenobtained,

(b) evidence establishing to the Purchaser's satisfactionthat the Bidder has complied with all the documentaryrequirements for registration as specified in the BidData Sheet.

6.4.1 The Purchaser shall at all times cooperate with thesuccessful Bidder to facilitate the registration processwithin the Purchaser's country. The agency and contactperson able to provide additional infornation aboutregistration are identified in the Bid Data Sheet.

6.4.2 If the Goods of the successful Bidder have not beenregistered in the Purchaser's country at the time ofContract sighing, then the Contract shall becomeeffective upon such date as the Certificate ofRegistration is obtained.

6.5 For purposes of the commentary to be furnished pursuant toITB Clause 6.3 (b) above, the Bidder shall note thatstandards as well as references to brand names designatedby the Purchaser in its Technical Specifications are intendedto be descriptive only and not restrictive. The Bidder maysubstitute alternative standards, brand names, and/or catalognumbers in its bid, provided that it demonstrates to thePurchaser's satisfaction Lhat the substitutions ensuresubstantial equivalence to those designated in the TechnicalSpecifications.

7. Qualifications of 7.1 The Bidder shall provide documentary evidence tothe Bidder establish to the Purchaser's satisfaction that:

(a) the Bidder has the financial, technical, and productioncapability necessary to perform the Contract, meetsthe qualification criteria specified in the Bid DataSheet, and has a successful performance history inaccordance with criteria specified in the Bid DataSheet. If a prequalification process has beenundertaken for the Contract, the Bidder shall, as partof its bid, update any information submitted with itsapplication for prequalification.

(b) in the case of a Bidder offering to supply HealthSector Goods, identified in the Bid Data Sheet, thatthe Bidder did not manufacture or otherwise produce,


the Bidder has been duly authorized by themanufacturer or producer of such Goods to supply theGoods in the Purchaser's country;

(c) in the case of a Bidder who is not doing businesswithin the Purchaser's country (or for other reasonswill not itself carry out service/maintenanceobligations), the Bidder is or will be (if awarded theContract) represented by a local service/maintenanceprovider in the Purchaser's country equipped and ableto carry out the Bidder's warranty obligationsprescribed in the Conditions of Contract and/orTechnical Specifications; and

(d) the Bidder meets the qualification criteria listed in theBid Data Sheet (see additional clauses of Bid DataSheet for pharmaceuticals and vaccines).

8. One Bid per 8.1 A firm shall submit only one bid either individually or as aBidder partner of a joint venture (other than in cases of alternatives

pursuant to ITB Clause 20). A firm that submits eitherindividually or, as a member of a joint venture, more thanone bid will cause all the proposals with the firm'sparticipation to be disqualified.

9. Cost of Bidding 9.1 The Bidder shall bear all costs associated with the preparationand submission of its bid, and the Purchaser will in no casebe responsible or liable for those costs, regardless of theconduct or outcome of the bidding process.

B. THE BIDDING DOCUMENTS

10. Content of 10.1 The Bidding Documents are those stated below and should beBidding read in conjunction with any addendum issued in accordanceDocuments with ITB Clause 12.

Section I. Instructions to Bidders (ITB)Section II. Bid Data Sheet (BDS)Section IV. General Conditions of Contract (GCC)Section V. Special Conditions of Contract (SCC)Section VI. Schedule of RequirementsSection VII. Technical SpecificationsSection VIII. Sample Forms (including Contract

Agreement)


10.2 The "Invitation for Bids" does not form part of the BiddingDocuments and is included as a reference only. In case ofdiscrepancies between the Invitation for Bid and theBidding Documents listed in 10.1 above, said BiddingDocuments will take precedence.

11. Clarification of 11.1 A prospective Bidder requiring any clarification of the BiddingBidding Documents shall contact the Purchaser in writing or by cableDocuments (for these ITB, the term "cable" is deemed to include electronic

mail, telex, or facsimile) at the Purchaser's address indicatedin the Bid Data Sheet. The Purchaser will respond inwriting to any request for clarification received no laterthan fourteen (14) calendar days prior to the deadline ofsubmission of bids. Copies of the Purchaser's response shall besent to all prospective Bidders who have purchased the BiddingDocuments, including a description of the inquiry but withoutidentifying its source.

12. Amendment of 12.1 At any time prior to the deadline for submission of bids, theBidding Purchaser may amend the Bidding Documents by issuingDocuments Addenda.

12.2 Any addendum thus issued shall be part of the BiddingDocuments pursuant to ITB Sub-Clause 10.1 and shall becommunicated in writing to all purchasers of the BiddingDocuments and will be binding on them. Bidders arerequired to immediately acknowledge receipt of any suchamendment, and it will be assumed that the informationcontained in the amendment will have been taken intoaccount by the Bidder in its bid.

12.3 To give prospective Bidders reasonable time in which totake the amendment into account in preparing their bids, thePurchaser shall extend, at its discretion, the deadline forsubmission of bids, in which case, the Purchaser will notifyall Bidders by cable confirmed in writing of the extendeddeadline.

C. PREPARATION OF BIDS

13. Language of Bid 13.1 The bid, as well as all correspondence and documentsrelating to the bid exchanged by the Bidder and thePurchaser, shall be written in the language specified in theBid Data Sheet. Supporting documents and printed


literature fmrnished by the Bidder may be in anotherlanguage provided they are accompanied by an accuratetranslation of the relevant passages in the language specifiedin the Bid Data Sheet, in which case, for purposes ofinterpretation of the Bid, the translation shall govern.

14. Documents 14.1 The bid submitted by the Bidder shall comprise theConstituting the following:Bid

(a) duly filled-in Form of Bid and Price Schedule, inaccordance with the forms indicated in Section VIII;

(b) original form of bid security in accordance with theprovisions of ITB Sub-Clause 19 (Bid Security);

(c) alternative offers, at the Bidder's option, whenpermitted;

(d) written power of attorney authorizing the signatory ofthe bid to commit the Bidder;

(e) in the absence of prequalification, documentaryevidence in accordance with ITB Sub-Clause 4.4establishing to the Purchaser's satisfaction theBidder's eligibility to bid including but not limited todocumentary evidence that the Bidder is legallyincorporated in a territory of an eligible sourcecountry as defined under ITB Clause 4;

(f) documentary evidence establishing to the Purchaser'ssatisfaction, and in accordance with ITB Clause 6that the Goods and ancillary services to be suppliedby the Bidder are eligible Goods and Services,pursuant to ITB Clause 5, and that they conform tothe Bidding Documents;

(g) documentary evidence establishing to the Purchaser'ssatisfaction, and in accordance with ITB Clause 7 thatthe Bidder is qualified to performn the Contract if its bidis accepted. In the case where prequalification ofBidders has been undertaken, and pursuant to ITBParagraph 7.1 (a) the Bidder must provide evidence onany changes in the information submitted as the basisfor prequalification, or if there has been no change at allin said information, a statement to this effect;


(h) any other documentation as requested in the Bid DataSheet.

15. Bid Form 15.1 The Bidder shall complete the Bid Form and the appropriatePrice Schedule firnished in the Bidding Documents,indicating the Goods to be supplied, a brief description ofthe Goods, their country of origin, quantity, and prices.

15.2 For the purpose of granting a margin of domesticpreference, bids will be classified in one of three groups, asfollows:

(a) Group A: Bids offering Health Sector Goodsmanufactured in the Purchaser's country, for which(i) labor, raw materials, and components from withinthe Purchaser's country account for more than thirty(30) percent of the EXW price; and (ii) theproduction facility in which they will be produced ormanufactured has been engaged in producing ormanufacturing such Goods at least since the date ofbid submission.

(b) Group B: All other bids offering Health SectorGoods from within the country of the Purchaser.

(c) Group C: Bids offering Goods of foreign origin to beimported by the Purchaser directly or through theSupplier's local agent.

15.3 To facilitate this classification by the Purchaser, the Biddershall complete whichever version of the Price Schedulefurnished in the Bidding Documents is appropriateprovided, however, that the completion of an incorrectversion of the Price Schedule by the Bidder will not resultin rejection of its bid, but merely in the Purchaser'sreclassification of the bid into its appropriate bid group.

16. Bid Prices 16.1 The Bidder shall indicate on the appropriate Price Schedule,as applicable, the unit prices of each item, total prices ofeach lot, and the total Bid price of the Goods it proposes tosupply under the Contract.

16.2 Prices indicated on the Price Schedule shall be enteredseparately in the following manner:

(a) For Goods offered from within the Purchaser'scountry:


(i) the price of the Goods quoted EXW (ex works,ex factory, ex warehouse, ex showroom, or off-the-shelf, as applicable), including all customsduties and sales tax and other duties and taxesalready paid or payable:

- on the components and raw material used inproducing or manufacturing the Goodsquoted ex works or ex factory;

- on the previously imported Goods offoreign origin quoted ex warehouse, exshowroom, or off-the-shelf.

(ii) any Purchaser country sales and other taxes thatwill be payable on the Goods if the Contract isawarded.

(iii) the price for inland transportation, insurance, andother local costs incidental to delivery of theGoods to their final destination, if specified inthe Bid Data Sheet.

(iv) the price of other incidental Services, if any,listed in the Bid Data Sheet.

(b) For Goods offered from abroad:

(i) the price of the Goods shall be quoted CIFnamed port of destination, CIP border point, orCIP named place of destination, in thePurchaser's country, as specified in the Bid DataSheet. In quoting the price, the Bidder shall befree to use transportation through carriersregistered in any eligible countries. Similarly,the Bidder may obtain insurance services fromany eligible source country.

(ii) the price of the Goods quoted FOB port ofshipment (or FCA, as the case may be), ifspecified in the Bid Data Sheet.

(iii) the price of Goods quoted CFR port ofdestination (or CPT as the case may be), ifspecified in the Bid Data Sheet.

(iv) the price for inland transportation, insurance, andother local costs incidental to delivery of the


Goods from the port of entry to their finaldestination, if specified in the Bid Data Sheet.

(v) the price of incidental Services, if any, listed inthe Bid Data Sheet.

16.3 The terms EXW, CIF, CIP, etc., shall be governed by therules prescribed in the current edition of Incotermspublished by the International Chamber of Commerce,Paris.

16.4 The Bidder's separation of price components in accordancewith ITB Clause 16.2 above will be solely for the purposeof facilitating the comparison of bids by the Purchaser andwill not in any way limit the Purchaser's right to contract onany of the terms offered.

16.5 Unless otherwise specified in the Bid Data Sheet, pricesquoted by the Bidder shall be fixed during the Bidder'sperformance of the Contract and not subject to variation on anyaccount. A bid submitted with an adjustable price quotationwill be treated as nonresponsive and will be rejected, pursuantto ITB Clause 29. If, however, in accordance with the BidData Sheet, prices quoted by the Bidder shall be subject toadjustment during the performance of the Contract, a bidsubmitted with a fixed price quotation will not be rejected, butthe price will not be adjusted.

16.6 Pursuant to Sub-Clause 16.1 above, and if so indicated inthe Bid Data Sheet, bids are being invited for one or moreitems, or for individual Contracts (lots) each comprising atleast eighty percent (80%) of the total number of itemsrequired under the lot. In both cases, each item offered mustcomprise the full quantity required under that item. Bidderswishing to offer any price reduction for the award of morethan one Contract shall specify in their bid the pricereductions applicable to each package or, alternatively, toindividual Contracts within the package. Price reductionsmay be submitted as an amount or a percentage to beapplied to the bid prices.

17. Currencies of Bid 17.1 Prices shall be quoted in the following currencies:

(a) The Bidder may express the bid price of the HealthSector Goods to be supplied from outside thePurchaser's Country entirely in the currency or


currencies of Bank member countries. If the Bidderwishes to be paid in a combination of differentcurrencies, it must quote its price accordingly, but nomore than three foreign currencies may be used.Bidders expressing their foreign currencyrequirements in any of the national currencies of theEuropean Monetary Union or in euro should do so inaccordance with the provisions of the Bid Data Sheet.

(b) Unless otherwise specified in the Bid Data Sheet, theBidder shall express its prices for such goods to besupplied from within the Purchaser's country in thecurrency of the country of the borrower.

18. Period of Validity 18.1 Bids shall remain valid for the period stipulated in the Bidof Bids Data Sheet after the date of bid submission specified in ITB

Clause 23. A bid valid for a shorter period shall be rejectedby the Purchaser as nonresponsive.

18.2 In exceptional circumstances, prior to expiry of the originalbid validity period, the Purchaser may request that theBidders extend the period of validity for a specifiedadditional period. The request and the responses theretoshall be made in writing. A Bidder may refuse the requestwithout forfeiting its bid security. Except as provided inITB Clause 18.3, a Bidder agreeing to the request will notbe required or permitted to modify its bid, but will berequired to extend the validity of its bid security for theperiod of the extension.

18.3 In the case of fixed price contracts, if the award is delayedby a period exceeding fifty-six (56) days beyond the expiryof the first bid validity extension, the contract price will beincreased by a factor that reflects changes in the cost ofinputs specified in the request for second and subsequentextensions.

19. Bid Security 19.1 Unless otherwise specified in the Bid Data Sheet, theBidder shall furnish, as part of its bid, a bid security in theamount stipulated in the Bid Data Sheet in the currency ofthe Purchaser's country, or the equivalent amount in a freelyconvertible currency.

19.2 The bid security shall remain valid for a period of 28 daysbeyond the validity period for the bid.


19.3 The bid security shall be denominated in the currency of thePurchaser's country, or in a freely convertible currency, andshall be, at the Bidder's option, in one of the followingforms:

(a) a cashier's or certified check;

(b) a letter of credit issued by a reputable bank located inany eligible country;

(c) a (bank) guarantee issued by a reputable bank selectedby the Bidder located in any eligible country. Theformat of the (bank) guarantee shall be in accordancewith the form of bid security included in Section VIIIor any other form acceptable to the Purchaser.

19.4 Any bid not accompanied by an acceptable bid securityshall be rejected by the Purchaser as nonresponsive. Thebid security of a joint venture must be in the name of thejoint venture submitting the bid.

19.5 The bid securities of unsuccessful Bidders will be returnedas promptly as possible, but not later than 28 days after theexpiration of the period of bid validity.

19.6 The bid security of the successful Bidder will be returnedwhen the Bidder has signed the Agreement and furnishedthe required performance security.

19.7 The bid security may be forfeited

(a) if the Bidder withdraws its bid, except as provided inITB Sub-Clauses 18.2 and 25.3; or

(b) if the Bidder does not accept the correction of its bidprice, pursuant to ITB Clause 30; or

(c) in the case of a successful bidder, if the Bidder failswithin the specified time limit to:

(i) sign the agreement, or

(ii) furnish the required performance security.

20. Alternative 20.1 Unless specified in the Bid Data Sheet, alternative bidsProposals by shall not be accepted.Bidders


21. Format and 21.1 The Bidder shall prepare an original and the number of

Signing of Bid copies/sets of the bid indicated in the Bid Data Sheet,clearly marking each one as "ORIGINAL BID" and "COPYOF BID," as appropriate. In the event of any discrepancybetween them, the original shall govern.

21.2 The original and all copies of the bid, each consisting of thedocuments listed in ITB Sub-Clause 14.1, shall be typed orwritten in indelible ink and shall be signed by the Bidder ora person or persons duly authorized to bind the Bidder tothe Contract. The later authorization shall be indicated bywritten power of attorney, which pursuant to ITB Sub-Clause 14.1 (d) shall accompany the bid.

21.3 Any interlineation, erasures, or overwriting to correct errorsmade by the Bidder should be initialed by the person orpersons signing the bid.

21.4 The Bidder shall furnish in the Bid Formn (a sample of whichis provided in the Sample Forms Section of the BiddingDocuments) information regarding commissions or gratuities,if any, paid or to be paid to agents relating to this bid and tothe execution of the Contract if the Bidder is awarded theContract.

D. SUBMISSION OF BIDS

22. Sealing and 22.1 The Bidder shall enclose the original and each copy of the

Marking of Bids bid including alternative bids, if permitted in accordancewith ITB Clause 20, in separate sealed envelopes, dulymarking the envelopes as "ORIGINAL" and "COPY." Theenvelopes containing the original and copies shall then beenclosed in another envelope.

22.2 The inner and outer envelopes shall:

(a) bear the name and address of the Bidder;

(b) be addressed to the Purchaser at the address given inthe Bid Data Sheet;

(c) bear the specific identification of this bidding processindicated in the Bid Data Sheet, the Invitation forBids (IFB) title and number indicated in the Bid DataSheet; and


(d) bear a statement "DO NOT OPEN BEFORE [date andtime]" to be completed with the time and date specifiedin the Bid Data Sheet relating to ITB Sub-Clause 23.1.

22.3 If the outer envelope is not sealed and marked as required byITB Sub-Clause 22.2, the Purchaser will assume noresponsibility for the misplacement or premature opening ofthe bid.

23. Deadline for 23.1 Bids must be received by the Purchaser at the addressSubmission of specified in the Bid Data Sheet relating to ITB Sub-ClauseBids 22.2 (b) no later than the time and date specified in the Bid

Data Sheet.

23.2 The Purchaser may, at its discretion, extend the deadline forthe submission of bids by amending the Bidding Documentsin accordance with ITB Sub-Clause 12.3, in which case allrights and obligations of the Purchaser and Bidderspreviously subject to the deadline will thereafter be subjectto the deadline as extended.

24. Late Bids 24.1 Any bid received by the Purchaser after the deadline forsubmission of bids prescribed by the Purchaser in the BidData Sheet pursuant to ITB Clause 23 will be rejected andreturned unopened to the Bidder.

25. Modification and 25.1 The Bidder may modify or withdraw its bid afterWithdrawal of submission, provided that written notice of theBids modification, or withdrawal of the bids duly signed by an

authorized representative, is received by the Purchaser priorto the deadline prescribed for submission of bids.

25.2 The Bidder's modification shall be prepared, sealed,marked, and dispatched as follows:

(a) The Bidder shall provide an original and the number ofcopies specified in the Bid Data Sheet of anymodifications to its bid, clearly identified as such, intwo inner envelopes duly marked "BIDMODIFICATION-ORIGINAL" and "BIDMODIFICATION-COPIES." The inner envelopesshall be sealed in an outer envelope, which shall beduly marked "BID MODIFICATION."

(b) Other provisions concerning the marking and dispatchof bid modifications shall be in accordance with ITBSub-Clauses 22.2 and 22.3.


25.3 A Bidder wishing to withdraw its bid shall notify thePurchaser in writing prior to the deadline prescribed for bidsubmission. A withdrawal notice shall be received prior tothe deadline for submission of bids. The notice ofwithdrawal shall:

(a) be addressed to the Purchaser at the address named inthe Bid Data Sheet,

(b) bear the specific identification of the bidding process(Contract name), the IFB title and IFB number, andthe words "BID WITHDRAWAL NOTICE," and

(c) be accompanied by a written power of attorneyauthorizing the signatory of the withdrawal notice towithdraw the bid.

25.4 Bids requested to be withdrawn in accordance with ITBSub-Clause 25.3, shall be returned unopened to the Bidders.

25.5 No bid may be withdrawn in the interval between the bidsubmission deadline and the expiration of the bid validityperiod specified in ITB Clause 18. Withdrawal of a bidduring this interval may result in the forfeiture of theBidder's bid security, pursuant to ITB Sub-Clause 19.7.

E. OPENING AND EVALUATION OF BIDS

26. Bid Opening 26.1 The Purchaser will open all bids, including withdrawalnotices and modifications, in public, in the presence ofBidders' representatives who choose to attend, at the time,on the date, and at the place specified in the Bid DataSheet. Bidders' representatives shall sign a register as proofof their attendance.

26.2 Envelopes marked "WITHDRAWAL" shall be read out andthe envelope with the corresponding bid shall not be openedbut returned to the Bidder. No bid withdrawal notice shallbe permitted unless the corresponding withdrawal notice isread out at bid opening. Envelopes marked"MODIFICATION" shall be read out and opened with thecorresponding bid.

26.3 Bids shall be opened one at a time, reading out: the name ofthe Bidder and whether there is a modification; the bid price


of each item or lot, as the case may be, including discountsand alternative offers, if allowed in the Bid Data Sheet; thepresence or absence of a bid security, if required; thepresence or absence of requisite powers of attorney; and anyother such details as the Purchaser may considerappropriate. No bid shall be rejected a bid opening exceptfor late bids pursuant to Sub-Clause 24.1.

26.4 Bids (and modifications sent pursuant to ITB Sub-Clause25.2) that are not opened and read out at bid opening shallnot be considered further for evaluation, irrespective of thecircumstances.

26.5 The Purchaser will prepare minutes of the bid opening at theend of the opening session, including, as a minimum: thename of the Bidder and whether there was a withdrawal ormodification; the bid price; including any discounts oralternatives offered if permitted in the Bid Data Sheet; thepresence or absence of a bid security; the presence orabsence of requisite powers of attorney.

The Bidder's representatives who are present shall berequested to sign the minutes. The omission of a Bidder'ssignature on the minutes shall not invalidate the content andeffect of the minutes. The minutes should be distributed toall Bidders who request them.

27. Clarification of 27.1 During evaluation of the bids, the Purchaser may, at itsBids discretion, ask the Bidder for a clarification of its bid. The

request for clarification and the response shall be in writing,and no change in the prices or substance of the bid shall besought, offered, or permitted, except to correct arithmeticerrors identified by the Purchaser in the evaluation of thebids, in accordance with ITB Sub-Clause 30.1.

28. Confidentiality 28.1 Information relating to the examination, clarification,evaluation, and comparison of bids, and recommendationsfor the award of a Contract shall not be disclosed to biddersor any other persons not officially concerned with suchprocess until the notification of Contract award is made toall Bidders.

28.2 Any effort by the bidder to influence the Purchaser in thePurchaser's bid evaluation, bid comparison, or contractaward decisions may result in the rejection of the Bidder'sbid.


28.3 From the time of bid opening to the time of Contract award,if any Bidder wishes to contact the Purchaser on any matterrelated to its bid, it should do so in writing.

29. Examination of 29.1 The Purchaser will examine the bids to determine whetherBids and they are complete, whether any computational errors haveDetermination of been made, whether required sureties have been furnished,Responsiveness whether the documents have been properly signed, and

whether the bids are generally in order. In the case where aprequalification process has been undertaken for theContract(s) for which these Bidding Documents have beenissued, the Purchaser will ensure that each bid is from aprequalified Bidder.

29.2 The Purchaser may waive any minor informality,nonconformity, or irregularity in a bid that does notconstitute a material deviation, provided such waiver doesnot prejudice or affect the relative ranking of any Bidder.

29.3 Prior to the detailed evaluation, pursuant to ITB Clause 32,the Purchaser will determine whether each bid is ofacceptable quality, is complete, and is substantiallyresponsive to the Bidding Documents. For purposes of thisdetermination, a substantially responsive bid is one thatconforms to all the terms, conditions, and specifications ofthe Bidding Documents without material deviations,exceptions, objections, conditionalities, or reservations. Amaterial deviation, exception, objection, conditionality, orreservation is one: (i) that limits in any substantial way thescope, quality, or performance of the Goods and relatedServices; (ii) that limits, in any substantial way that isinconsistent with the Bidding Documents, the Purchaser'srights or the successful Bidder's obligations under theContract; and (iii) that the acceptance of which wouldunfairly affect the competitive position of other Bidderswho have submitted substantially responsive bids.

29.4 If a bid is not substantially responsive, it will be rejected bythe Purchaser and may not subsequently be made responsiveby the Bidder by correction of the nonconformity. ThePurchaser's determination of a bid's responsiveness is to bebased on the contents of the bid itself, and any writtenclarification submitted by the Bidder in accordance withITB Sub-Clause 27.1.

30 Section I. Instructions to Bidders

30. Correction of 30.1 Arithmetical errors will be rectified as follows. If there is aErrors discrepancy between the unit price and the total price that is

obtained by multiplying the unit price and quantity, the unitor subtotal price shall prevail. If there is a discrepancybetween subtotals and the total price, the total price shall becorrected. If there is a discrepancy between words andfigures, the amount in words will prevail. If a Bidder doesnot accept the correction of errors, its bid will be rejectedand its bid security may be forfeited.

31. Conversion to 31.1 To facilitate evaluation and comparison, the Purchaser willSingle Currency convert all bid prices expressed in the various currencies in

which they are payable to either:

(a) the currency of the Purchaser's country at the sellingexchange rate established for similar transactions bythe Central Bank or a commercial bank in thePurchaser's country.

or

(b) a currency widely used in international trade, such asU.S. dollars, at the selling rate of exchange publishedin the international press for the amount payable inforeign currency; and at the selling exchange rateestablished for similar transactions by the CentralBank in the Purchaser's country for the amountpayable in the currency of the Purchaser's country.

31.2 With regard to ITB Paragraphs 31.1 (a) and 31.1 (b) above,prices quoted in the national currencies of the EuropeanMonetary Union will be converted to the euro using theirrevocable fixed exchange rates between the formernational currencies and the euro. The amounts in euro willthen be converted to the single currency at the exchangerates established pursuant to ITB Sub-Clause 31.3 and inaccordance with the provisions of the Bid Data Sheet.

31.3 The currency selected for converting bid prices to acommon base for the purpose of evaluation, along with thesource and date of the exchange rate, are specified in theBid Data Sheet.

32. Evaluation and 32.1 The Purchaser will evaluate and compare the bids that haveComparison of been determined to be substantially responsive, pursuant toBids ITB Clause 29.


32.2 The Purchaser's evaluation of a bid will exclude and nottake into account:

(a) in the case of Goods manufactured in the Purchaser'scountry or Goods of foreign origin already located inthe Purchaser's country, sales and other similar taxes,that will be payable on the Goods if a contract isawarded to the Bidder;

(b) in the case of Goods of foreign origin offered fromabroad, customs duties and other similar import taxesthat will be payable on the Goods if the contract isawarded to the Bidder; and

(c) any allowance for price adjustment during the periodof execution of the Contract, if provided in the bid.

The evaluation shall include and take into account:

(d) any direct taxes levied on the Bidder, or the Bidder'semployees, subcontractor, or the subcontractor'semployees.

(e) any indirect taxes on the Goods required as inputs tothe Goods supplied under the Contract.

32.3 The comparison shall be between the EXW price of theGoods offered from within the Purchaser's country, suchprice to include all costs, as well as duties and taxes paid orpayable on components and raw material incorporated or tobe incorporated in the Goods, and the CIF named port ofdestination (or CIP border point, or CIP named place ofdestination) price of the Goods offered from outside thePurchaser's country.

32.4 The Purchaser's evaluation of a bid will take into account,in addition to the bid price quoted in accordance with ITBSub-Clause 16.2, one or more of the following factors asspecified in the BDS, and quantified in ITB Sub-Clause32.5:

(a) subject to ITB Sub-Clause 16.2 (a) (iii) or 16.2 (b) (iv)the cost of inland transportation, insurance, and othercosts within the Purchaser's country incidental todelivery of the Goods to their final destination;

(b) delivery schedule offered in the bid;


(c) deviations in payment schedule from that specified inthe Special Conditions of Contract;

(d) other specific criteria indicated in the Bid Data Sheetand/or in the Technical Specifications.

32.5 For factors retained in the Bid Data Sheet pursuant to ITBSub-Clause 32.4, one or more of the followingquantification methods will be applied, as detailed in theBid Data Sheet:

(a) Inland transportation from EXW/port of entry/borderpoint, insurance, and incidentals.

Inland transportation, insurance, and other incidentalcosts for delivery of the Health Sector Goods fromEXW/port of entry/border point to the site named inthe Bid Data Sheet will be computed for each bid bythe Purchaser on the basis of published tariffs by therail or road transport agencies, insurance companies,and/or other appropriate sources. To facilitate suchcomputation, Bidder shall furnish in its bid theestimated dimensions and shipping weight and theapproximate EXW/CIF (or CIP border point) value ofeach package. The above cost will be added by thePurchaser to EXW/CIF/CIP border point price.

(b) Delivery schedule.

(i) The Purchaser requires that the Health SectorGoods under these Bidding Documents shall bedelivered (shipped) at the time specified in theSchedule of Requirements. The estimated timeof arrival of the Health Sector Goods at the sitewill be calculated for each bid after allowing forreasonable international and inlandtransportation time. A delivery "adjustment" willbe calculated for and added to each bid byapplying a percentage, specified in the Bid DataSheet, of the EXW/CIF/CIP price for each weekof delay beyond the expected time of arrivalspecified in the Bidding Documents forevaluation purposes. No credit shall be given toearly delivery.

or


(ii) The Health Sector Goods covered under theseBidding Documents are required to be delivered(shipped) within an acceptable range of weeksspecified in the Schedule of Requirements. Nocredit will be given to earlier deliveries, and bidsoffering delivery beyond this range will betreated as nonresponsive. Within this acceptablerange, an adjustment per week, as specified inthe Bid Data Sheet, will be added for evaluationto the bid price of bids offering deliveries laterthan the earliest delivery period specified in theSchedule of Requirements.

or

(iii) The Health Sector Goods covered under thisinvitation are required to be delivered (shipped)in partial shipments, as specified in the Scheduleof Requirements. Bids offering deliveries earlieror later than the specified deliveries will beadjusted in the evaluation by adding to the bidprice a factor equal to a percentage, specified inthe Bid Data Sheet, of EXW/CIF/CIP price perweek of variation from the specified deliveryschedule.

(c) Deviation in payment schedule.

(i) Bidders shall state their bid price for the paymentschedule outlined in the SCC. Bids will beevaluated on the basis of this base price. Biddersare, however, permitted to state an alternativepayment schedule and indicate the reduction inbid price they wish to offer for such alternativepayment schedule. The Purchaser may considerthe alternative payment schedule offered by theselected Bidder.

or

(ii) The SCC stipulate the payment schedule offeredby the Purchaser. If a bid deviates from theschedule and if such deviation is permitted in theBid Data Sheet, the bid will be evaluated bycalculating interest earned for any earlierpayments involved in the terms outlined in the


bid as compared with those stipulated in thisinvitation, at the rate per annum specified in theBid Data Sheet.

(d) Other specific additional criteria to be considered inthe evaluation and the evaluation method shall bedetailed in the Bid Data Sheet and/or in the TechnicalSpecifications.

33. Domestic 33.1 If indicated in the Bid Data Sheet and for the purpose ofPreference bid comparison, the Purchaser will grant a margin of

preference to Goods manufactured in the Purchaser'scountry. This margin of preference will be granted inaccordance with the procedures outlined in subsequentparagraphs, provided the Bidder shall have established tothe satisfaction of the Purchaser and of the Bank that its bidcomplies with the criteria specified in ITB Paragraph 15.2(a).

33.2 The Purchaser will first review the bids to confirm theappropriateness of, and to modify if necessary, the bidgroup classification to which Bidders assigned their bids inpreparing their Bid Forms and Price Schedules.

33.3 All evaluated bids in each group will then be comparedamong themselves to determine the lowest evaluated bid ofeach group. The lowest evaluated bid of each group willnext be compared with the lowest evaluated bids of theother groups. If this comparison results in a bid from GroupA or Group B being the lowest, it will be selected forContract award.

33.4 If, as a result of the preceding comparison, the lowestevaluated bid is from Group C, all Group C bids will thenbe further compared with the lowest evaluated bid fromGroup A, after adding to the evaluated bid price of theimported Goods offered in each Group C bid, for thepurpose of this further comparison only:

(a) the amount of customs duties and other import taxesthat a nonexempt importer would have to pay for theimportation of Goods offered in each Group C bid;

or


(b) fifteen (15) percent of the CIF (or CIP border point orCIP named place of destination, as the case may be)bid price of such Goods, if the customs duties that anonexempt importer would have to pay and taxesexceed fifteen (15) percent of the CIF (or CIP borderpoint or CIP place of destination) price of such Goods.

(c) Domestic preference will be applied only to thoseitems indicated in the Schedule of Requirements thatmeet the criteria under Paragraph 15.2 (a).

If the Group A bid in the further comparison is the lowest, itwill be selected for award. If not, the lowest evaluated bidfrom Group C, as determined from the comparison underITB Sub-Clause 33.3 above, will be selected for award.

F. AWARD OF CONTRACT

34. Postqualification 34.1 In the absence of prequalification, the Purchaser willdetermine to its satisfaction whether the Bidder that isselected as having submitted the lowest evaluatedresponsive bid is qualified to perform the Contractsatisfactorily, in accordance with the criteria listed in ITBSub-Clause 7.1 and any additional postqualification criteriastated in the Bid Data Sheet. If a prequalification processwas undertaken for the Contract(s) for which these BiddingDocuments were issued, the Purchaser will determine in themanner described above that no material changes haveoccurred after the prequalification that negatively affect theability of the Bidder that has submitted the lowest evaluatedbid to perform the Contract.

34.2 The determination will evaluate the Bidder's financial,technical, and production capabilities. It will be based onan examination of the documentary evidence of the Bidder'squalifications submitted by the Bidder, pursuant to ITBSub-Clause 7.1, as well as other information the Purchaserdeems necessary and appropriate.

34.3 An affirmative postqualification determination will be aprerequisite for award of the contract to the lowestevaluated Bidder. A negative determination will result inrejection of the Bidder's bid, in which event the Purchaserwill proceed to the next-lowest evaluated Bidder to make a


similar determination of that Bidder's capabilities toperform satisfactorily.

35. Award Criteria 35.1 Pursuant to ITB Clauses 32, 33, and 38, the Purchaser willaward the Contract to the Bidder whose bid has beendetermined to be substantially responsive and has beendetermined to be the lowest evaluated bid, provided furtherthat the Bidder is determined to be qualified to perform theContract satisfactorily, pursuant to ITB Clause 34.

36. Purchaser's 36.1 The Purchaser reserves the right to accept or reject any bid,Right to Accept or to annul the bidding process and reject all bids at anyAny Bid and to time prior to contract award, without thereby incurring anyReject Any or All liability to the affected Bidder or Bidders.Bids

37. Purchaser's 37.1 The Purchaser reserves the right at the time of ContractRight to Vary award to increase or decrease, by the percentage indicated inQuantities at the Bid Data Sheet, the quantity of goods and servicesTime of Award beyond that originally specified in the Schedule of

Requirements without any change in unit price or otherterms and conditions.

38. Notification of 38.1 Prior to the expiration of the period of bid validity, theAward Purchaser will notify the successful Bidder in writing by

registered letter or by cable, to be subsequently confirmedin writing by registered letter, that its bid has been accepted.

38.2 The notification of award will constitute the formation ofthe Contract.

38.3 Upon the successful Bidder's furnishing of the signedContract Form and performnance security pursuant to ITBClause 40, the Purchaser will promptly notify eachunsuccessful Bidder and will discharge its bid security,pursuant to ITB Clause 19.

38.4 If, after notification of award, a Bidder wishes to ascertainthe grounds on which its bid was not selected, it shouldaddress its request to the Purchaser. The Purchaser willpromptly respond in writing to the unsuccessful Bidder.

39. Signing of 39.1 Promptly after the Purchaser notifies the successful Bidder thatContract its bid has been accepted, the Purchaser will send the Bidder

the Contract Form provided in the Bidding Documents,incorporating all agreements between the parties.


39.2 Within twenty-eight (28) days of receipt of the ContractForm, the successful Bidder shall sign and date the ContractForm and return it to the Purchaser.

40. Performance 40.1 Within twenty-eight (28) days of the receipt of notificationSecurity of award from the Purchaser, the successful Bidder shall

furnish the performance security in accordance with theConditions of Contract, using the Performance SecurityForm provided in the Bidding Documents, or in anotherform acceptable to the Purchaser.

40.2 Failure of the successful Bidder to comply with therequirement of ITB Clause 39 or ITB Sub-Clause 40.1 shallconstitute sufficient grounds for the annulment of the awardand forfeiture of the bid security, in which event thePurchaser may make the award to the next-lowest evaluatedbid submitted by a qualified Bidder or call for new bids.

39

SECTION II. BID DATA SHEET

40 Section 11. Bid Data Sheet

NOTES ON THE BID DATA SHEET

Section 11 is intended to assist the Purchaser in providing the specificinformation in relation to corresponding clauses in the Instructions to Biddersincluded in Section I and has to be prepared for each specific procurement.

The Purchaser should specify in the Bid Data Sheet information andrequirements specific to the circumstances of the Purchaser, the processing of theprocurement, the applicable rules regarding bid price and currency, and the bidevaluation criteria that will apply to the bids. In preparing Section 11, the followingaspects should be checked:

(a) The correct version of the Bid Data Sheet must be used as a base,dependent upon the type of Goods being procured. For example, if changesor additions are made to the Bid Data Sheet it may require changes to thecorresponding SCC.

(b) Information that specifies and complements provisions of Section 1, ITB, mustbe incorporated.

(c) Amendments and/or supplements, if any, to provisions of Section 1, ITB, asrequired by the circumstances of the specific procurement, must also beincorporated.

Section 11. Bid Data Sheet 41

Bid Data Sheet

The following specific data for the Goods to be procured shall complement, supplement, oramend the provisions in the Instructions to Bidders (ITB). Whenever there is a conflict, theprovisions in the Bid Data Sheet (BDS) shall prevail over those in the ITB.

A. GENERAL

..................... . .............. ......................... .. ...N. a.... ..n....e.......f................ s..e.r..: n...a.. .m . .......e.....o.f ...P ......................... r.J -. .....................................ITB 1 .1 Name of Purchaser: [insert: name of Purchaser]J.

Name of authorized Purchasing Agent: [if appropriate, insert:name of the PurchasingAgent, otherwise state: "none"].

Type of goods: [insert pharmaceuticals, nutritional supplements,or injectable hormonal contraceptive].

Name and identification number of the Contract: [insert: name andidentification number of the Contract .

-- -------- . ... ... ._....... . . .. .. . .. .. .. . . ........... ...... . .............. ....... ................. . ..... .... . ........ ........ .. .

ITB 2.1 Name ofthe Borrower: [insert: name of Borrower].

Loan or credit number: [insert: loan /credit number ]

Loan or credit amount: [insert: loan / credit amount as stated inthe Loan Agreement governing the project ].

Name of Project: [insert: name of project .

ITB 4.1 & 5.1 Applicable edition of the Guidelines: Procurement under IBRDLoans and IDA Credits: [insert either: the date of latestedition, for example "January 1995, Revised January andAugust 1996, September 1997, and January 1999" or insert.the date of the edition specified in the Loan Agreementgoverning the project].

. . ... . .. . . .. .. . ... .......... , ... ... ........... ... .......... ..... ..... . ....... ..... . . . ... . . ........... .... . ....... . ....... . ..... ...... . .......

ITB 6.3 (c) Documentation requirements for eligibility of Goods. In addition tothe documents stated in Clause 6.2 and 6.3 (a) and (b), thefollowing documents should be included with the Bid:

[Insert: any other eligibility documentation required]

.. . .... ..._ . . .. . ..... ..... .... ... ..... .. . .... ..... .. . . . ......! .... . ......... .. .

42 Section II. Bid Data Sheet

..- -- - -- -- -- -- .......... -- ..... -- ... .. -.-..- ................. ..... ........... ... ....... ..............- ----.-._._.-....... . ......_-.-.._. ..... ._ _ ---- ._._._. _._._ .... . ........ _.._....... .... ........................ . ......._ ._._.._ . ................ ...... ...j ITB 6.4 '' [Note: If the Purchaser's country does not require registration of

the Goods, delete 6.4 (b) and 6.4.1 below and insert thefollowing language.

ITB Sub-Clause 64 is inapplicable. The Applicable Lawdoes not require registration of the Goods to be supplied*under the Contract.]

Note: The Purchaser shall not annul award of a Contract onthe basis of a Bidder's failure to successfully registerthe Goods, without first seeking and obtaining theWorld Bank's no objection. There shall be no forfeitureof a bid security based on the failure to obtainregistration.

ITB 6.4 (b) By the time of Contract signing, the successful Bidder shall havecomplied with the following documentary requirements inorder to register the Goods to be supplied under the Contract:[insert: specific documentary requirements j

ITB 6.4.1 For the purpose of obtaining additional information about therequirements for registration, Bidders may contact [ insert:name of agency, contact person, phone/fax/email address I

.. .... . -- - ---- .................... .......... ... . .... . ... ... ...... ..

ITB 7.1(a) Qualification requirements for Bidders are:

[insert, as appropriate: quantifiable qualification criteria forexperience and/or financial viability ].

The following documents must be included with the bid:

Documentary evidence of the Bidder 's qualifications to perform theContract if its bid is accepted:

(i) that, in the case of a Bidder offering to supply Goods underthe Contract that the Bidder manufactures or otherwiseproduces (using ingredients supplied by primarymanufacturers) that the Bidder.

(a) is incorporated in the country of manufacture of theGoods;

(b) has been licensed by the regulatory authority in thecountry of manufacture to supply the Goods,-

.~~~~~~~~~~~~~~~onr ds;

.L......... . ... . - -- ---.._.. . .. . . .. . .. _ . _ . ..... . .. .. _ . ... .. ... . . . .. . . .... . ... . . . ... . ........ .. ............_ .._._ .. .. ...... ...


(c) has manufactured and marketed the specifc goods

covered by this Bidding Document, for at least two (2)years, andfor similar Goods for at leastfive (5) years;

(d) has received a satisfactory GMP inspectioncertificate in line with the WHO certification schemeon pharmaceuticals moving in InternationalCommerce from the regulatory authority (RA) in thecountry of manufacture of the goods or has beencertified by the competent authority of a membercountry of the Pharmaceuticals InspectionConvention (PIC), and has demonstrated compliancewith the quality standards during the past two yearsprior to bid submission;

(ii) that, in the case of a Bidder offering to supply Goods underthe Contract that the Bidder does not manufacture orotherwise produce,

(a) that the Bidder has been duly authorized by amanufacturer of the Goods that meets the criteriaunder (i) above to supply the Goods in thePurchaser 's country; and

The Bidder shall also submit the following additional information:

(a) a statement of installed manufacturing capacity;

(b) copies of its auditedfinancial statements for the pastthreefiscal years;

(c) details of on-site quality control laboratory facilitiesand services and range of tests conducted;

(d) list of major supply contracts conducted within thelast five years.

. Note: In addition, guidance on what qualificationrequirements are reasonable is given in the Bank'sPTN on the Procurement of Health Sector Goods. Ifbids for individual lots are permitted, the qualificationcriteria for each lot should be given separately.

In the case where a prequalification process has beenundertaken, the qualification criteria stated here shouldmirror the criteria established in the prequalification.

. ..... ....... ..... ...... .................. ............... .......... .............. ....... ..................... .............. ..... ..................... ....... .. ......... ........... ... .. ...... .. ............-............... . .............. ......... ... ................ .................... .....


B. THE BIDDING DOCUMENTS

ITB 11.1 Purchaser's / duly authorized Purchasing Agent's address: [insert:Purchaser's address, telephone, telex, and facsimilenumbers; also specify a responsible contact person orofficer to whom Bidder communications should beaddressed J

..... .. ...... ... .. ...... .. .... ....... ...... ........ . . ... ......... . .. ....... ... ..... .. ..... .... .. ... ... ... .. ........... ... .......... ... ...... .. ......................... ............ ......... ... .. ............ ............. ..... ......... ..... .... .........

C. PREPARATION OF BIDS

ITB 13.1 The language of all correspondence and documents related to the bidis: [select: English /French /Spanish]. Moreover, thekey passages of all accompanying printed literature in anyother language must be translated into the above language.

. ..... .... ............. . ........ ...... .. ... ... ........ .. ..... ....... . . . ......... . ..... . ..... . . .... . ........... .. .... ...... ....... .... . ............. .. _. ....... ... .. ... . . ..... . ....... ..... .. ..... .......... ............. .. ........ .. ..

ITB 14.1 (i) In addition to the documents stated in Paragraphs 14.1 (a) through(h), the following documents must be included with the Bid[insert: list of documents ].

[Sample clause]

Bidders who are not primary manufacturers should provideevidence that their product conforms to the quality standardsof the primary manufacturer and they have the capacity tosupply the specified quantities. A "primary manufacturer" isdefined as a company that performs all the manufacturingand formulating operations needed to producepharmaceuticals or nutritional supplements in theirappropriate dosage forms, including processing, blending,formulating, filling, packing, labeling, and quality testing.The Bidder shall furnish a certificate from the competentRegulatory Authority (RA) that the manufacturer is licensedto manufacture the Goods offered.

........ .... ............. . .... .......... . ... ........ ....... .. ... ....... ... ...... ..... ...... ............. ......... ....... . ........ .. .......... ....... ... .......... . ........... .. ................ . ........................ ........ . .......... . .. ........... .. .. ...... .. ........ .................... ....

ITB 16.2 (a) Prices for inland transportation, insurance, and other local costs(iii), (iv) (optional) incidental to delivery of the Goods offered from within the

Purchaser's country shall be quoted as:~~~~~~~~~~~~~.......................... ........... .... ........... .. ...... ............ . ... .......... _ _.......... _ _......... .... .. i.... . .......... ... . .......... ... .................................... ........... .... ......... ... ............... ...... ........................... - ----- ....... .....


Price of other incidental services shall be quoted as:

[specify EXW and whether prices for inland transportationand price of incidental services, must be quoted in additionto EXW].

Note: If the price for inland transportation is not to be quotedseparately, then estimated dimensions and shippingweight of each package should be requested inaccordance with 32.5 (a). The related provisions shallbe reflected accordingly in SCC and Price Schedules.

ITB 16.2 (b) (i) Prices for Goods offered from abroad shall be quoted as:(ii), (iii) (optional)- (iv), (v) (optional) [ select, in accordance with the Schedule of Requirements,

"CIP named place of destination or CIP border point or CIFnamed port of destination" J.

f specify whether FOB or FCA prices (or other terms, CFRor CPT) are required pursuant to ITB Sub-Paragraph 16.2(b) (ii) or (iii) ].

[specify whether prices for inland transportation and pricesof incidental services, pursuant to ITB Sub-Paragraph 16.2(b) (iv) and (v), must be quoted in addition to the above CIFor CIP prices].

Note: If the price for inland transportation is not to be quotedseparately, then estimated dimensions and shippingweight of each package should be requested inaccordance with 32.5 (a). The related provisions shallbe reflected accordingly in SCC and Price Schedules.

ITB 16.5 Prices quoted by the Bidder shall be state: 'fixed"; or, if a priceadjustment mechanism is required, then specify the exactformula that will apply, including the nature of the indicesthat will be used ].

.................. ... .... ......... .. ... ... .... .... ................. .. . ............... ........ ....... . ............. .. .......... .. ......... ...... ... .... ......... .. ......... .............. . ................... .... ........... .. ... ........ ... ... .. ..... ..

ITB 16.6 Bids are being invited for [ indicate "one or more items," or"individual contracts (lots)"]

, T 7 . . ....(.a ... ..... .. U.......(... n. ....... .).U.........n..... ... ........................ .... ................. ..................... ............. ............................... .................... .........

,ITB 17.1 (a) ,Until December 31, 2001, bid prices may also be expressed in the!.. ....... .... . .... .... ... ....... - - . ..... ........ .. .................. ........ ....I.... ......... . .. ..... W.... ...... ........ ... ... ......... ......... .. ..I..... . .......... .. . ...... ........ ... ....... - - .......... ........ .


former national currencies of the member countries of t eEuropean Monetary Union (the Austrian schilling, Belgianfranc, Finnish markka, French franc, Deutsche mark, Irishpound, Italian lira, Luxembourg franc, Netherlands guilder,Portuguese escudo, Spanish peseta).

ITB 17.1 (b) The currency to be used for quoting prices of the Goods andServices components of the Goods offered from within thePurchaser's country, as well as local currency expendituresfor local technical support, training, maintenance,transportation, insurance, and other local costs incidental todelivery, is: [select: currency of Purchaser's country /other currency, as specified by the Purchaser I

Note: Bid prices are usually lower if Bidders are allowed toquote and be paid in either the currency of expenditureor another internationally traded currency of theirchoice.

Normally the currency of bid and payment for locallysupplied Health Sector Goods and Services is thecurrency of the Purchaser's country. However,Borrowers may allow domestic Bidders to bid in astable foreign currency for their local costs.Alternatively, they may allow those prices to beadjusted. If payments must be made in the localcurrency to conform to local law or regulation, any suchpayments due to a domestic Supplier are convertedfrom the currency of bid to local currency at theexchange rate prevailing at the time of payment.

The presence of such restriction on the currency ofpayment for locally supplied Health Sector Goods andServices, as well as the precise method of selecting theexchange rate to use in such a case (i.e., the date/timeand source of the exchange rate), must be specified inthe SCC regarding payment, along with the presence ofsuch restrictions on the currency of payment for locallysupplied Health Sector Goods and Services.

, ITB 18. .- The bid validity period shall be [insert: number )(2 X days afterthe deadline for bid submission, as specified below inL _ -~~~~~~~~~~~~~~~~. .... .... . ....... .. . .. .......... ... .... .... . .... ............. ......

Section II. Bid Data Sheet 47

................... ........... ..... ..... . ....................... . ....... ........ . .. .. .. ..... .. .......... ..I. ............... ...... . ..... . ....... . ............ .... ...... .......I.. .... ..... .. ...... ....... ....... .. I...... ...... 1. ....... ......

reference to ITB Clause 23. Accordingly, each bid shall bevalid through [ insert: the actual date of the expiration ofthe bid validity period (i.e., X days after the date of bidopening)].

Note: The bid validity period should be sufficient to permitcompletion of the evaluation, review of therecommended award by the management of theimplementing agency and the Bank, the receipt of allnecessary approvals, including the Bank's no objection,and issuance of the notification of award. In mostcases ninety (90) days should be adequate, butwhatever period is selected, it should be realistic sothat requests for extensions are kept to the minimum.

Bid security must be valid twenty-eight (28) days after the end of thebid validity period. Accordingly, a bid with a bid securitythat expires before [insert: the actual date of the expirationof the bid security, i.e., twenty-eight (28) days after the endof the bid validity period ] shall be rejected as nonresponsive.

Note: Bank experience also shows that many bids arerejected on the basis of simple errors in calculating thebid security validity period. Accordingly, the Purchasershould explicitly state above the date through which bidsecurity must be valid.

ITB 19.1 The amount of bid security required is: [insert: fixed amount andcurrency].

Note: The amount may be expressed as either a fixedamount or an amount "not less than" a specifiedpercentage of the Bidder's bid price. To avoidpremature disclosure of bid prices by commercial bankpersonnel or others, a fixed amount of not less than 2percent to no more than 3 percent of the budgetestimate for the contract (estimated) bid amount isstrongly recommended. (Requiring higher bid securityrisks driving away potentially qualified Bidders.) Askingfor smaller, or even no bid security at all, however, isacceptable for simple contracts where the market isrelatively stable and mature.

Also, in the case of Bidding Documents coveringmultiple lots, a bid security should be specified as

. _._ _._._ . . . . . _._ . _._ _._ . .. . . - . . _._._ .. .. _._._ . . ._ .... .......... _ ................... ........ ........ _._ ....... .................. ......................... ............. _ .. _._._ .. . _._._ ... . _._ .. _._.


representing not less than "x" percent of the total BidPrice for all lots covered by the bid.

ITB 20.1 Alternatve id [indicate: will or will not] be accepted.

Note: When Bidders are permitted to submit alternative bids,only the alternative submitted by the Bidder whosebasic bid is the lowest evaluated bid will be considered.Such alternatives will be evaluated in accordance withthe evaluation criteria and methods specified in thisBDS. An alternative bid can be selected for award onlyif it was submitted by the Bidder whose basic bid is thelowest evaluated bid. The alternative bid must be fullyresponsive to the requirements specified in the BidData Sheet, the SCC, and the Specifications of theBidding Documents and the lowest evaluated bid whencompared with the basic bid submitted by the bidder.

The evaluation criteria are [ insert. criteria j

Requirements for responsive bids are [ insert: requirements j

ITB 21.1 Required number of copies of the bid: [insert: number (X) ofcopies].

..... .... , .... ....... ..... . . .... ... .. .... . . _._ ...._ _.._. A._ ............. .... ........ .. _._ .. .. ... ................. ... ........._. _ _._.__. .......... ........ ...... .................

D. SUBMISSION OF BIDS

ITB 22.2 (b) The address for bid submission is: [insert: address adequate formail, courier, or physical delivery, including responsibleofficer or person I.

Note: Do not use a postal box or similar address.

.. . ........... ...... . ........ . . ... .. ....... ............ . .... ....... .................................................. .. ....... ............... ........ .. . ............................. . ....

ITB 22.2 (c) & (d) See the above data for ITB 1.1 for the name of the Contract.

The Invitation for Bids title and number are: [if applicable, insert:Invitation for Bids Title and Invitation for Bids Number (ifany), otherwise, state "none"]

. . . ........ .... .. . . ..... ...... . .... . ....... .. . ... . .... . .......... .......... ....... w. ........ --...... ....... ..................... ............ i.. .......... ... :....... ..... ................... ...... ...... ............... ............... .. ..................... ........... ............ .................. .


See the below data for ITB 23.1 for the deadline for bid submission.

Note: The Purchaser should establish a clear andrecognizable numbering system for its Contracts.Failure to do so typically results in misunderstandingsin routine communications, review delays, andinadequate monitoring of overall project progress.

ITB 23.1 See the above data for ITB Sub-Clause 22.2 (b) for the address anddeadline for bid submission.

Deadline for bid submission is: [insert: date and time ].

Note: The bid submission date is generally six to twelveweeks from the date of issuance of the BiddingDocuments, depending on the value, scope, and/orcomplexity of the Health Sector Goods beingpurchased.

.. .... ................. .. .... ....... .. ..... ..... .. ........... . .. ...... .............. ...... .......... ... ....... .. . .. . ... . .. .... .. . ...... .... .. .......... ......... ............ . ... . .............. ...... . ............ ............ ................ ................ .......... ..

ITB 24.1 See the above data for ITB Sub-Clause 23.1 for the deadline for bidsubmission.

ITB 25.2 (a) The required number of copies of bid modifications is the same as:the number of copies of the original bid specified above inthe data for ITB Sub-Clause 21.1.

ITB 25.3 (a) See the above data for ITB Paragraph 22.2 (b) for the address to usefor submission of a bid withdrawal notice.

~~~~~~~~~~~~~~~~~~~.. .... . ....... .. . ........ .... . ... . . ........ ... . . .. .... .......... .. ......... ..... ... ........... ... ... . .. .... ..... ....... .......... .. .. ............ . ..- ...... . . .......... .... .. ..... .... ....... . .. ..... . . .. ..... .............

E. BID OPENING AND EVALUATION

................... .............. ... ........ ............... ................ . ........... ...... ...... .. .... - .. . ... ....... ... . . ....... . ...... ........ ..... . . ........ ..... ........ . ..... .......... ... ... . ........ ... .......... ....

ITB 26.1 Time, date, and place for bid opening are: [insert: time, date, andplace J.

Note: The date for the bid opening should be the same asspecified for the bid submission deadline, and the time


~~~~~~~~~~~~~~~~~~~... . .... . ,....... ... ...... .. .......... ..... . .............. ........ ...... ......... . .. .................-...... . ............. ....... ......-----.... ..... .. ... ............ .... ...... ...... . ............ .. ....................... .. .................... . ....... ..... . . . ..- - ................. . _..

should be shortly thereafter, to minimize possiblecomplaints regarding insecure storage arrangements.If the address for bid submission and the place of bidopening are not the same, adequate time between bidsubmission deadline and bid opening times should beallowed, to accommodate physically moving the bidsfrom one site to the other. However, this delay must bekept to a minimum and reflect only the requirements oflogistics, say, no more than two hours.

~~~~~~~~~~~......... .. .. ...... .... . 4 ... .... ............... .......... ... .... ..... ...... ........... ... ..... . . ..................... . .. ............... ..... ........ ..... ............. ........ ........... ..... ......... .... .......... ................ ...... .. ..............

i ITB 31.2 On January 1, 1999, the euro was substituted for the currencies ofthe member countries if the European Monetary Union. Fromthat date, these currencies were irrevocably fixed vis-a-visthe euro. Until December 31, 2001, these currencies remainin existence as nondecimal subdenominations of the euro.

jITB 31.3 Th currency chosen or the purpose of converting to a commoncurrency is: [ specify either: the local currency, or a 1convertible currency commonly used for procurement of,Health Sector Goods, for example, U.S. dollars j

The source of exchange rate is: [insert: publication, name of bank,,etc.].

jNote: If the common currency is other than the localcurrency, for example, U.S. dollars, indicate the nameof an internationally circulated newspaper that listsdaily currency selling exchange rates, which will be

i used for converting prices in foreign currencies. Forprices in local currency and if the common currencyselected above is the local currency, specify either theCentral Bank or a commercial bank in the Purchaser'scountry, and identify the publication where the specifiedrates are published.

The date of exchange rate determination is: [select: a date thatshall not be earlier than four (4) weeks prior to the originaldeadline for the receipt of bids as specif edfor ITB Sub-Clause 23.1, and no later than the expiration of the originalbid validity period ].

............ ..... ..... . ..... . ......... .. .... ..... ........ ........ .... .... ...... .. ....... . .... .. ..... . ............ . .......... .... .......... .. ...... ............_. . .................. .... .......... ............. ............................ ... ... ..........

ITB 32.4 (d) The evaluation will take into account [insert: factors and otherspecific criteria /.

... . .......... .. .... ...... . . ....... .................... .. ......... . .. .......... ,... . ......... ........... ................ _.. . ...... .. ... .. ......... . ..... ... ...... .. ... .. ... ... ............. ..... . ........... ..... .......... . ...... ...... . ................ .......


ITB 32.5 The factors retained pursuant to ITB Sub-Clause 32.4 nd thequantification methods are: [insert: factors ].

............ ........... ....... ....... ..... .. ..... ... ...... . .. ........... . ...... .. ... . ..... . .... .... .... ... ... ...... . ............... .......... ............ .......... .. .............. ...... ...... ........... .. .......... ..... .. ......... .. ......... . ...... ..

ITB 32.5 (a) Inland transportation from EXW/port of entry/border point to[insert: name of project site(s) I insurance and incidentals.

Bidder shall furnish:

[state: estimated dimensions and shipping weight of each packageand approximate EXW/CIF/CIP value of each package ].

Note: This information is not required when the Bidders areinvited to submit a bid in accordance with ITB Sub-:Paragraph 16.2 (a) (iii) or ITB Sub-Paragraph 16.2 (b) (iv).

ITB 32.5 (b) (i) (ii) Delivery schedule [specify: relevant parameters in accordance with& (iii) - option selected].

The adjustment per week for delivery delays beyond the timespecified in the Schedule of Requirements is [ specify:adjustment in percentage ].

or

The adjustment per week for delivery delays beyond the range ofweeks specified in the Schedule of Requirements is [specify:adjustment in percentage ].

or

The adjustment for partial shipments is [specify: adjustmentsforearly and late deliveries J.

Note: For evaluation purposes, a rate of one-half (0.5)percent per week is a reasonable figure.

ITB 32.5 (c) (ii) The Purchaser [select: will / will not accept deviations in thepayment schedule in the SCC.

Note: If deviations are accepted, add the following text.

The percentage adjustment for payment schedule deviations is:[insert: percentage J % per week.

............................. ..... .. ... ........... ..... .. ... .. ............ . .... .... .. ............... ...... ......... .. ....... ...... ................ ......... ..... .... ... ... ..... .............. .. ........ . .... .......... ....................... ..................


.. ....... -. -.----------- - ---- ._. ... _ ........ ... __. ....-. _...-.-... ..... . ........... 1 .... _. _......... ....... ... . .... ........ ................ .................

Note: If inflation expectations widely diverge between local'and foreign currencies, and Bidders are expected toquote significant amounts in local currencies, differentadjustment rates for local and foreign currency pricesshould be provided.

._ ... _._. ._ ~~~~~~~~~~~~~~~~~~~~~~~~.... __... ....... ... ... ..... _. ... ..... .. .............................. ..... .. ........... ................ . ........... .. ....... ... ..... .............. ........... ........ .............. .

ITB 32.5 (d) [ insert. other factors to be used in the evaluation and theirevaluation method or reference to the TechnicalSpecifications]

Evaluation criteria for items/lots

[Select one of the two sample clauses below]

If bids have been invitedfor items only, the BDS should statethe following:

Bidders may bid for any one or more items. Bids will beevaluated for each item and the Contract will comprise theitem(s) awarded to the successful Bidder.

If lots will be accepted, the BDS should state the following:

Bidders can bidfor one or more lots. Bids will be evaluatedlot by lot. Bidders must quote for the entire quantity of eachitem and at least eighty percent (80%) of the number of itemsin the lot to be treated as substantially responsive.

Bid evaluation of such bids will be carried out as per thefollowing procedures. The average price of an item quotedby substantially responsive bidders will be added to the bidprice of those who did not quote for that item and theequivalent total cost of the bid so determined will be usedforbid comparison, evaluation, and award.

ITB 33.1 A margin of domestic preference [specijy: wil or will not] apply.

L_ . ..... .. ...... . ...... ........ ... ..... ...... . .. ....... . ............... ............ .. ....... ... ............ ......... ..... ... .......... . ... .... ......... ....... ... ........ ...... ..... ..... ....---- ....... . . .. ....... .............. ......................... ..............


F. POSTQUALIFICATION AND AWARD OF CONTRACT

~~~~~~~~~......... ... .... .. ... ... ...... ........ .. ........... .... ... ...... .. .... .. .............. .. ... ................ ... .................. ... ............ ................. ...... .... .. ... .............. ...... ..... ......... .. ................

ITB 34.1 Postqualification

[insert: Any specific postqualification requirements, such as therequired number of years of manufacturing experience.]

ITB 37.1 Percentage for irncrease or decrease of quantity of Goods andServices originally specified: [insert: percentage not more

than 20% ].

55

Bid Data Sheet

PHARMACEUTICALS(Additional Clauses)

[Note: The below data should be included in the Bid Data Sheet used in BiddingDocuments for the procurement of pharmaceuticals.]

ITB 6.3 (c) [Sample clauses]

The Goods offered should meet the specifiedpharmacopoeialstandards as stated in the Technical Specification. If theGoods offered are not included in one of the specifiedpharmacopoeias (e.g., the case of a new drug), the Bidderwill provide testing protocols and alternative referencestandards.

.~ ~ ~ ~ ~ ~~~~~~. . .. ... . ................. ........... ....

ITB 7.1 (a) & (d) Documentary evidence of the Bidder 's qualif ications to perform theContract if its bid is accepted:

(ii) (d) has a Good Distribution Practice (GDP) Certificatewhere appropriate.

The Bidder will submit the following additional information:

(e) list of pharmaceuticals being manufactured by theBidder with product registration/license number anddate.

(f) a Certificate of Pharmaceutical Product asrecommended by the WHO for each item offered.

57

Bid Data Sheet

VACCINES(Additional Clauses)

[Note: The below data should be included in the Bid Data Sheet used in BiddingDocuments for the procurement of vaccines.]

The following specific data for the Goods to be procured shall complement, supplement, oramend the provisions in the Instructions to Bidders (ITB). Whenever there is a conflict, theprovisions in the Bid Data Sheet (BDS) shall prevail over those in the ITB.

A. GENERAL

............................... ...... ............ .. ... ....... .. ... .... ............... ......... .... .................. .......... .. .... .. . ....... ...... .... ........... ............. ........ . ...... ... .... ....... .. ............ ...... .. ........ ....... .. . ......... ......... ...... ........ ........ .......

ITB 6.3 (c) [Sample clauses]

, 1. The Goods to be supplied under the Contract must be'licensed both in the country of manufacture and in thePurchaser's country by the time of Contract signing by arecognized NCA. An NCA is an organization that performsall six critical functions for control of biological products as.defined by the World Health Organization, namely: licensingbased on published set of requirements; surveillance ofvaccine field performance; system of lot release for vaccines;,use of laboratory when needed; regular inspections for goodmanufacturing practice and evaluation of clinicalperformance. The license from country of manufacture must,state that the Bidder is licensed to manufacture the Goods by'the NCA in the manufacturing country. Documentaryevidence in the form of a certified copy of the license and acopy of the vaccine license/registration that the offered:vaccine has been licensed by the NCAs of the manufacturer 'scountry shall accompany the bid and a copy of the license'issued by an NCA in the Purchaser's country must besubmitted by Contract signing. If there is no NCA withspecific biologics expertise in the Purchaser's country, theBidder shall furnish evidence that the Goods meet thequalification criteria in the Technical Specifications.

2. If the Goods offered do not meet the specified:pharmacopoeial standards as stated in the TechnicalSpecification, the Bidder will provide testing protocols andalternative reference standards.

......... ..... ..... . ......_. ....._. _. .... _.................. ..... . . ..... .... ...... _........ .. ......... ..... - ........ _ ... ................ . ............. .. ... ....... .... ........ _........... ... .... . ..... _

58 Section 11. Bid Data Sheet - Vaccines (Additional. Clauses)

ITB 7.1 (a) & (d) Documentary evidence of the Bidder's qualifications to perform the

Contract if its bid is accepted:

(e) is certified by a competent authority in the country of

manufacture according to resolution WHA 28 65 (2)of the World Health Organization 's Certificate

Scheme on the Quality of Pharmaceutical Products

Moving in International Commerce.

The Bidder will submit the following additional information:

- (fi list of vaccines being manufactured by the Bidder

with product registration/license number and date.

59

SECTION III. ELIGIBILITY FOR THE PROVISION

OF GoODS, WORKS, AND SERVICES IN BANK-FINANCED PROCUREMENT

60 Section III. Eligibility for Bank-Financed Procurement

NOTES ON THE ELIGIBILITY SECTION

Purchasers and suppliers may obtain the latest Eligibility sheet from either the Bank'sproject staff or from the World Bank's Web site:http:/Iwww.worldbank.org/html/pic/PROCURE.html. Replace the following page with themost current text. The Eligibility section must remain unaltered.

Section III. Eligibility for Bank-Financed Procurement 61

Public Information Center'

As of May 2000

For the information of borrowers and bidders, and with reference to paragraph 1.6, footnote9, of the Guidelines: Procurement under IBRD Loans and IDA Credits, dated January 1995,set forth below is a list of countries from which bidders, goods, and services are not eligibleto participate in procurement financed by the bank or IDA.2

. Andorra

. Cuba* Democratic People's Republic of Korea (North Korea). Liechtenstein. Monaco. Nauru* San Marino* Tuvalu

In addition, bidders, goods, and services from other countries or territories may be declaredineligible by a provision in bidding documents if the borrower's country has excluded themby a law, official regulation, or act of compliance meeting the requirements of paragraph 1.8(a) of the Guidelines: Procurement under IBRD Loans and IDA Credits.

The Loan/Credit Agreement also prohibits a withdrawal from the Loan/Credit Account forthe purpose of any payment to persons or entities, or for any import of goods, if suchpayment or import, to the knowledge of the Bank, is prohibited by a decision of the UnitedNations Security Council taken under Chapter VII of the Charter of the United Nations. Atthe present time, this prohibition applies to:

. Iraq

The most current listing of eligible countries can be viewed on the Public Information Center's Web pageat: http://www.worldbank.org/html/pic/PROCURE.html. A list of firms debarred from participating inWorld Bank projects is available at: http://www.worldbank.org/htmUopr/procure/debarr.html.

2 Any questions regarding this list should be addressed to the Director, Procurement Policy and ServicesGroup, Operational Core Services Network.

63

SECTION IV. GENERAL CONDITIONS OF

CONTRACT

64 Section IV. General Conditions of Contract

NOTES ON THE GENERAL CONDITIONS OF CONTRACT

The General Conditions of Contract (GCC) in Section IV, read in conjunction withthe Special Conditions of Contract (SCC) in Section V and other documents listed inthe Contract Agreement, should be a complete document expressing all the rightsand obligations of the parties.

GCC must remain unaltered. Contract-specific information, deletions, extensions,and modifications to the GCC shall be introduced only through the SCC.

Section IV. General Conditions of Contract 65

TABLE OF CLAUSES

1. Definitions .......................................................... 662. Application .......................................................... 673. Country of Origin .......................................................... 674. Standards .......................................................... 675. Use of Contract Documents and Information; Inspection and Audit by the Bank ... 686. Certification of Goods in Accordance with Laws of the Purchaser's Country ......... 687. Patent Rights .......................................................... 698. Performance Security .......................................................... 699. Inspections and Tests ........................... : 6910. Packing .......................... 7011. Delivery and Documents .......................... 7112. Insurance .......................... 7113. Transportation .......................... 7114. Incidental Services .......................... 7215. Warranty .......................... 7216. Payment .......................... 7417. Prices .......................... 7418. Change Orders .......................... 7419. Contract Amendments .......................... 7520. Assignment .......................... 7521. Delays in the Supplier's Performance .......................... 7522. Liquidated Damages .......................... 7623. Termination for Default .......................... 7624. Force Majeure .......................... 7725. Termination for Insolvency .......................... 7726. Termination for Convenience .......................... 7827. Settlement of Disputes .......................... 7828. Limitation of Liability .......................... 7929. Governing Language .......................... 7930. Applicable Law .......................... 7931. Notices .......................... 7932. Taxes and Duties .......................... 80


General Conditions of Contract

1. Definitions 1.1 In this Contract, the following terms shall be interpreted asindicated:

(a) "The Contract" means the agreement entered intobetween the Purchaser and the Supplier, as recorded inthe Contract Form signed by the parties, including allattachments and appendices thereto and all documentsincorporated by reference therein.

(b) "The Contract Price" means the price payable to theSupplier under the Contract for the full and properperformance of its contractual obligations.

(c) "Day" means calendar day.

(d) "Effective Date" means the date on which this Contractbecomes effective pursuant to GCC Clause 6.2.

(e) "Eligible Country" means the countries and territorieseligible for participation in procurements financed bythe World Bank as defined in the Guidelines:Procurement under IBRD Loans and IDA Credits.

(f) "End User" means the organization(s) where the goodswill be used, as named in the SCC.

(g) "GCC" means the General Conditions of Contractcontained in this section.

(h) "The Goods" means all of the pharmaceuticalsincluding nutritional supplement and oral and injectableforms of contraception, vaccines, and condoms that theSupplier is required to supply to the Purchaser underthe Contract.

(i) "The Purchaser" means the organization purchasing theGoods, as named in the SCC.

(j) "The Purchaser's country" is the country named in theSCC.

(k) "Registration Certificate" means the certificate ofregistration or other documents in lieu thereofestablishing that the Goods supplied under the Contract


are registered for use in the Purchaser's country inaccordance with the Applicable Law.

(1) "SCC" means the Special Conditions of Contract.

(m) "The Services" means those services ancillary to thesupply of the Goods, such as transportation andinsurance, and any other incidental services, such asprovision of technical assistance, training, and othersuch obligations of the Supplier covered under theContract.

(n) "The Site," where applicable, means the place or placesnamed in the SCC.

(o) "The Supplier" means the individual or firm supplyingthe Goods and Services under this Contract, as namedin the SCC.

(p) "The World Bank" means the International Bank forReconstruction and Development (IBRD) or theInternational Development Association (IDA).

2. Application 2.1 These General Conditions shall apply to the extent that theyare not superseded by provisions of other parts of theContract.

3. Country of 3.1 All Goods and Services supplied under the Contract shallOrigin have their origin in the countries and territories eligible under

the rules of the World Bank, as further elaborated in theSCC.

3.2 For purposes of this Clause, "origin" means the place wherethe Goods were mined, grown, or produced, or from whichthe Services are supplied. Goods are produced when,through manufacturing, processing, or substantial and majorassembly of components, a commercially recognized newproduct results that is substantially different in basiccharacteristics or in purpose or utility from its components.

3.3 The origin of Goods and Services is distinct from thenationality of the Supplier.

4. Standards 4.1 The Goods supplied under this Contract shall conform to thestandards mentioned in the Technical Specifications and,when no applicable standard is mentioned, to theauthoritative standards appropriate to the Goods' country of


origin. Such standards shall be the latest issued by theconcerned institution.

5. Use of Contract 5.1 The Supplier shall not, without the Purchaser's prior writtenDocuments and consent, disclose the Contract, or any provision thereof, orInformation; any specification, plan, drawing, pattern, sample, orInspection and information furnished by or on behalf of the Purchaser inAudit by the connection therewith, to any person other than a personBank employed by the Supplier in the performance of the Contract.

Disclosure to any such employed person shall be made inconfidence and shall extend only so far as may be necessaryfor purposes of such performance.

5.2 The Supplier shall not, without the Purchaser's prior writtenconsent, make use of any document or informationenumerated in GCC Sub-Clause 5.1 except for purposes ofperforming the Contract.

5.3 Any document, other than the Contract itself, enumerated inGCC Sub-Clause 5.1 shall remain the property of thePurchaser and shall be returned (all copies) to the Purchaseron completion of the Supplier's performance under theContract if so required by the Purchaser.

5.4 The Supplier shall permit the Bank to inspect the Supplier'saccounts and records relating to the performance of theContract and to have them audited by auditors appointed bythe Bank, if so required by the Bank.

6. Certification of 6.1 If required under the Applicable Law, Goods supplied underGoods in the Contract shall be registered for use in the Purchaser'sAccordance with country. The Purchaser undertakes to cooperate with theLaws of the Supplier to facilitate registration of the Goods for use in thePurchaser's Purchaser's country.Country

6.2 Unless otherwise specified in the SCC, the Contract shallbecome effective on the date ("the Effective Date") that theSupplier receives written notification from the relevantauthority in the Purchaser's country that the Goods have beenregistered for use in the Purchaser's country.

6.3 If thirty (30) days, or such longer period specified in theSCC, elapse from the date of Contract signing and theContract has not become effective pursuant to Sub-Clause6.2 above, then either party may, by not less than seven (7)


days' written notice to the other party, declare this Contractnull and void. In such event, the Supplier's performancesecurity shall be promptly returned.

7. Patent Rights 7.1 The Supplier shall indemnify the Purchaser against allthird-party claims of infringement of patent, trademark, orindustrial design rights arising from use of the Goods or anypart thereof in the Purchaser's country.

8. Performance 8.1 Within twenty-eight (28) days of receipt of the notification ofSecurity Contract award, the successful Bidder shall furnish to the

Purchaser the performance security in the amount specified inthe SCC.

8.2 The proceeds of the performance security shall be payable to thePurchaser as compensation for any loss resulting from theSupplier's failure to complete its obligations under the Contract.

8.3 The performance security shall be denominated in thecurrency of the Contract, or in a freely convertible currencyacceptable to the Purchaser, and shall be in one of thefollowing forms:

(a) a bank guarantee or an irrevocable letter of credit issuedby a reputable bank located in the Purchaser's countryor abroad, acceptable to the Purchaser, in the formatprovided in the Bidding Documents or another formatacceptable to the Purchaser; or

(b) a cashier's or certified check.

8.4 The performance security will be discharged by the Purchaserand returned to the Supplier not later than thirty (30) daysfollowing the date of completion of the Supplier's performanceobligations under the Contract, including any warrantyobligations, unless specified otherwise in the SCC.

9. Inspections and 9.1 The Purchaser or its representative shall have the right toTests inspect and/or to test the Goods to confirm their conformity

to the Contract specifications. The SCC and the TechnicalSpecifications shall specify what inspections and tests thePurchaser requires and where they are to be conducted. ThePurchaser shall notify the Supplier in writing, in a timelymanner, of the identity of any representatives retained forthese purposes.

(a) Said inspection and testing is for the Purchaser'saccount. In the event that inspection and testing is


required prior to dispatch, the Goods shall not beshipped unless a satisfactory inspection and qualitycontrol report has been issued in respect of thoseGoods.

(b) The Supplier may have an independent quality testconducted on a batch ready for shipment. The cost ofsuch tests will be borne by the Supplier.

(c) Upon receipt of the Goods at place of final destination,the Purchaser's representative shall inspect the Goodsor part of the Goods to ensure that they conform to thecondition of the Contract and advise the Purchaser thatthe Goods were received in apparent good order. ThePurchaser will issue an Acceptance Certificate to theSupplier in respect of such Goods (or part of Goods).The Acceptance Certificate shall be issued within ten(10) days of receipt of the Goods or part of Goods atplace of final destination.

9.2 Where the Supplier contests the validity of the rejection bythe Purchaser or his representative, of any inspection asrequired by 9.1 above conducted before shipment or atultimate destination, whether based on product or packinggrounds, a sample drawn jointly by the Supplier andPurchaser or his or her representative and authenticated byboth, will be forwarded for umpire analysis within fourweeks of the time the Supplier contests to an independentagency mutually agreed by the Purchaser and Supplier. Theumpire's finding, which will be promptly obtained, will befinal and binding on both parties. The cost of umpireanalysis will be borne by the losing party.

10. Packing 10.1 The Supplier shall provide such packing of the Goods as isrequired to prevent their damage or deterioration duringtransit to their final destination, as indicated in the Contract.The packing shall be sufficient to withstand, withoutlimitation, rough handling during transit and exposure toextreme temperatures, salt, and precipitation during transitand open storage. Packing case size and weights shall takeinto consideration, where appropriate, the remoteness of theGoods' final destination and the absence of heavy handlingfacilities at all points in transit.

10.2 The packing, marking, and documentation within and outsidethe packages shall comply strictly with such special


requirements as shall be expressly provided for in theContract, including additional requirements, if any, specifiedin the SCC or Technical Specifications, and in anysubsequent instructions ordered by the Purchaser.

11. Delivery and 11.1 Delivery of the Goods shall be made by the Supplier inDocuments accordance with the terms specified in the Schedule of

Requirements. The details of shipping and/or otherdocuments to be furnished by the Supplier are specified inthe SCC.

11.2 For purposes of the Contract, "EXW," "FOB," "FCA,""CIF," "CIP," and other trade terms used to describe theobligations of the parties shall have the meanings assigned tothem by the current edition of Incoterms published by theInternational Chamber of Commerce, Paris.

11.3 Documents to be submitted by the Supplier are specified inthe SCC. Incoterms provides a set of international rules forthe interpretation of the more commonly used trade terms.

12. Insurance 12.1 The Goods supplied under the Contract shall be fully insuredin a freely convertible currency against loss or damageincidental to manufacture or acquisition, transportation,storage, and delivery in the manner specified in the SCC.

12.2 Where delivery of the Goods is required by the Purchaser ona CIF or CIP basis, the Supplier shall arrange and pay forcargo insurance, naming the Purchaser as beneficiary. Wheredelivery is on an FOB or FCA basis, insurance shall be theresponsibility of the Purchaser.

13. Transportation 13.1 Where the Supplier is required under Contract to deliver theGoods FOB, transport of the Goods, up to and including thepoint of putting the Goods on board the vessel at thespecified port of loading, shall be arranged and paid for bythe Supplier, and the cost thereof shall be included in theContract Price. Where the Supplier is required under theContract to deliver the Goods FCA, transport of the Goodsand delivery into the custody of the carrier at the placenamed by the Purchaser or other agreed point shall bearranged and paid for by the Supplier, and the cost thereofshall be included in the Contract Price.

13.2 Where the Supplier is required under Contract to deliver theGoods CIF or CIP, transport of the Goods to the port ofdestination or such other named place of destination in the


Purchaser's country, as shall be specified in the Contract,shall be arranged and paid for by the Supplier, and the costthereof shall be included in the Contract Price.

13.3 Where the Supplier is required under the Contact to transportthe Goods to a specified place of destination within thePurchaser's country, defined as the Site, transport to suchplace of destination in the Purchaser's country, includinginsurance and storage, as shall be specified in the Contract,shall be arranged by the Supplier, and related costs shall beincluded in the Contract Price.

13.4 Where the Supplier is required under Contract to deliver theGoods CIF or CIP, no restriction shall be placed on thechoice of carrier. Where the Supplier is required underContract (a) to deliver the Goods FOB or FCA, and (b) toarrange on behalf and at the expense of the Purchaser forinternational transportation on specified carriers or onnational flag carriers of the Purchaser's country, the Suppliermay arrange for such transportation on alternative carriers ifthe specified or national flag carriers are not available totransport the Goods within the period(s) specified in theContract.

14. Incidental 14.1 The Supplier shall provide such incidental services, if any, asServices are specified in the SCC.

14.2 Prices charged by the Supplier for incidental services, if notincluded in the Contract Price for the Goods, shall be agreedupon in advance by the parties and shall not exceed theprevailing rates charged to other parties by the Supplier forsimilar services.

15. Warranty 15.1 All goods must be of fresh manufacture and must bear thedates of manufacture and expiry.

The Supplier further warrants that all Goods supplied underthe Contract will have remaining a minimum of five-sixths(5/6) of the specified shelf life upon delivery at port/airportof entry for goods with a shelf life of more than two yearsand three-fourths (3/4) for goods with a shelf life of twoyears or less, unless otherwise specified in the SCC; have"overages" within the ranges set forth in the TechnicalSpecifications, where applicable; are not subject to recall bythe applicable regulatory authority due to unacceptablequality or an adverse drug reaction; and in every otherrespect will fully comply in all respects with the Technical


Specifications and with the conditions laid down in theContract.

15.2 The Purchaser shall have the right to make claims under theabove warranty for three months after the Goods have beendelivered to the final destination indicated in the Contract.Upon receipt of a written notice from the Purchaser, theSupplier shall, with all reasonable speed, replace thedefective Goods without cost to the Purchaser. The Supplierwill be entitled to remove, at his own risk and cost, thedefective Goods once the replacement Goods have beendelivered.

15.3 In the event of a dispute by the Supplier, a counteranalysiswill be carried out on the manufacturer's retained samples byan independent neutral laboratory agreed by both thePurchaser and the Supplier. If the counteranalysis confirmsthe defect, the cost of such analysis will be borne by theSupplier as well as the replacement and disposal of thedefective goods. In the event of the independent analysisconfirming the quality of the product, the Purchaser willmeet all costs for such analysis.

15.4 If, after being notified that the defect has been confirmedpursuant to GCC Sub-Clause 15.2 above, the Supplier fails toreplace the defective Goods within the period specified inthe SCC, the Purchaser may proceed to take such remedialaction as may be necessary, including removal and disposal,at the Supplier's risk and expense and without prejudice toany other rights that the Purchaser may have against theSupplier under the Contract. The Purchaser will also beentitled to claim for storage in respect of the defective Goodsfor the period following notification and deduct the sum frompayments due to the Supplier under this Contract.

15.5 Recalls. In the event any of the Goods are recalled, theSupplier shall notify the Purchaser within fourteen (14) days,providing full details of the reason for the recall andpromptly replace, at its own cost, the items covered by therecall with Goods that fully meet the requirements of theTechnical Specification and arrange for collection ordestruction of any defective Goods. If the Supplier fails tofulfill its recall obligation promptly, the Purchaser will, at theSupplier's expense, carry out the recall.


16. Payment 16.1 The method and conditions of payment to be made to theSupplier under this Contract shall be specified in the SCC.

16.2 The Supplier's request(s) for payment shall be made to thePurchaser in writing, accompanied by an invoice describing,as appropriate, the Goods delivered and Services performed,and by documents submitted pursuant to GCC Clause 11, andupon fulfillment of other obligations stipulated in theContract.

16.3 Payments shall be made promptly by the Purchaser, but in nocase later than sixty (60) days after submission of an invoiceor claim by the Supplier.

16.4 The currency or currencies in which payment is made to theSupplier under this Contract shall be specified in the SCCsubject to the following general principle: Payment will bemade in the currency or currencies in which the payment hasbeen requested in the Supplier's bid.

16.5 All payments shall be made in the currency or currenciesspecified in the SCC pursuant to GCC 16.4. If both thespecified currency and, because of a membership in theEuropean Monetary Union (EMU), the euro are valid in thecountry of the specified currency, payments may also bemade in euro. In case the specified currency has ceased to bevalid in the country of the specified currency because of amembership in the EMU, payments shall be made in thecorresponding amount of the euro. The conversion of theamount of the specified currency into the euro shall in bothcases be made in accordance with the statutory rate ofconversion applicable in the country of the specifiedcurrency.

17. Prices 17.1 Prices charged by the Supplier for Goods delivered and Servicesperformed under the Contract shall not vary from the pricesquoted by the Supplier in its bid, with the exception of any priceadjustments authorized in the SCC or in the Purchaser'srequest for bid validity extension, as the case may be.

18. Change Orders 18.1 The Purchaser may at any time, by a written order given tothe Supplier pursuant to GCC Clause 31, make changeswithin the general scope of the Contract in any one or moreof the following:


(a) specifications, where Goods to be furnished under theContract are to be specifically manufactured for thePurchaser;

(b) the method of shipment or packing;

(c) the place of delivery; and/or

(d) the Services to be provided by the Supplier.

18.2 If any such change causes an increase or decrease in the costof, or the time required for, the Supplier's performance ofany provisions under the Contract, an equitable adjustmentshall be made in the Contract Price or delivery schedule, orboth, and the Contract shall accordingly be amended. Anyclaims by the Supplier for adjustment under this clause mustbe asserted within thirty (30) days from the date of theSupplier's receipt of the Purchaser's change order.

19. Contract 19.1 Subject to GCC Clause 18, no variation in or modification of

Amendments the terms of the Contract shall be made except by writtenamendment signed by the parties.

20. Assignment 20.1 The Supplier shall not assign, in whole or in part, itsobligations to perform under this Contract, except with thePurchaser's prior written consent.

21. Delays in the 21.1 Delivery of the Goods and performance of Services shall be

Supplier's made by the Supplier in accordance with the time schedulePerformance prescribed by the Purchaser in the Schedule of Requirements.

21.2 If at any time during performance of the Contract, theSupplier or its subcontractor(s) should encounter conditionsimpeding timely delivery of the Goods and performance ofServices, the Supplier shall promptly notify the Purchaser inwriting of the fact of the delay, its likely duration, and itscause(s). As soon as practicable after receipt of theSupplier's notice, the Purchaser shall evaluate the situationand may at its discretion extend the Supplier's time forperformance, with or without liquidated damages, in whichcase the extension shall be ratified by the parties byamendment of Contract.

21.3 Except as provided under GCC Clause 24, a delay by theSupplier in the performance of its delivery obligations shallrender the Supplier liable to the imposition of liquidateddamages pursuant to GCC Clause 22, unless an extension of


time is agreed upon pursuant to GCC Clause 21.2 without theapplication of liquidated damages.

22. Liquidated 22.1 Subject to GCC Clause 24, if the Supplier fails to deliver anyDamages or all of the Goods or to perform the Services within the

period(s) specified in the Contract, the Purchaser shall,without prejudice to its other remedies under the Contract,deduct from the Contract Price, as liquidated damages, a sumequivalent to the percentage specified in the SCC of thedelivered price of the delayed Goods or unperformedServices for each week or part thereof of delay until actualdelivery or performance, up to a maximum deduction of thepercentage specified in the SCC. Once the maximum isreached, the Purchaser may consider termination of theContract pursuant to GCC Clause 23.

23. Termination for 23.1 The Purchaser, without prejudice to any other remedy forDefault breach of Contract, by written notice of default sent to the

Supplier, may terminate this Contract in whole or in part:

(a) if the Supplier fails to deliver any or all of the Goodswithin the period(s) specified in the Contract, or withinany extension thereof granted by the Purchaser pursuantto GCC Clause 21; or

(b) if the Goods do not meet the Technical Specificationsstated in the Contract; or

(c) if the Supplier fails to provide any registration or othercertificates in respect of the Goods within the timespecified in the Special Conditions.

(d) if the Supplier, in the judgment of the Purchaser, hasengaged in corrupt or fraudulent practices in competingfor or in executing the Contract.

For the purpose of this clause:

"corrupt practice" means the offering, giving, receiving,or soliciting of any thing of value to influence theaction of a public official in the procurement process orin Contract execution.

"fraudulent practice" means a misrepresentation of factsin order to influence a procurement process or theexecution of a Contract to the detriment of theBorrower, and includes collusive practice among


Bidders (prior to or after bid submission) designed toestablish bid prices at artificial noncompetitive levelsand to deprive the Borrower of the benefits of free andopen competition.

(e) if the Supplier fails to perform any other obligation(s)under the Contract.

23.2 In the event the Purchaser terminates the Contract in wholeor in part, pursuant to GCC Clause 23.1, the Purchaser mayprocure, upon such terms and in such manner as it deemsappropriate, Goods or Services similar to those undelivered,and the Supplier shall be liable to the Purchaser for anyexcess costs for such similar Goods or Services. However,the Supplier shall continue performance of the Contract tothe extent not terminated.

24. Force Majeure 24.1 Notwithstanding the provisions of GCC Clauses 21, 22, and23, the Supplier shall not be liable for forfeiture of itsperformance security, liquidated damages, or termination fordefault if and to the extent that its delay in performance orother failure to perform its obligations under the Contract isthe result of an event of Force Majeure.

24.2 For purposes of this clause, "Force Majeure" means an eventbeyond the control of the Supplier and not involving theSupplier's fault or negligence and not foreseeable. Suchevents may include, but are not restricted to, acts of thePurchaser in its sovereign capacity, wars or revolutions, fires,floods, epidemics, quarantine restrictions, and freightembargoes.

24.3 If a Force Majeure situation arises, the Supplier shallpromptly notify the Purchaser in writing of such conditionand the cause thereof. Unless otherwise directed by thePurchaser in writing, the Supplier shall continue to performits obligations under the Contract as far as is reasonablypractical and shall seek all reasonable alternative means forperformance not prevented by the Force Majeure event.

25. Termination for 25.1 The Purchaser may at any time terminate the Contract byInsolvency giving written notice to the Supplier if the Supplier becomes

bankrupt or otherwise insolvent. In this event, terminationwill be without compensation to the Supplier, provided thatsuch termination will not prejudice or affect any right ofaction or remedy that has accrued or will accrue thereafter tothe Purchaser.


26. Termination for 26.1 The Purchaser, by written notice sent to the Supplier, mayConvenience terminate the Contract, in whole or in part, at any time for its

convenience. The notice of termination shall specify thattermination is for the Purchaser's convenience, the extent towhich performance of the Supplier under the Contract isterminated, and the date upon which such terminationbecomes effective.

26.2 The Goods that are complete and ready for shipment withinthirty (30) days after the Supplier's receipt of notice oftermination shall be accepted by the Purchaser at theContract terms and prices. For the remaining Goods, thePurchaser may elect:

(a) to have any portion completed and delivered at theContract terms and prices; and/or

(b) to cancel the remainder and pay to the Supplier anagreed arnount for partially completed Goods andServices and for materials and parts previouslyprocured by the Supplier.

27. Settlement of 27.1 If any dispute or difference of any kind whatsoever shallDisputes arise between the Purchaser and the Supplier in connection

with or arising out of the Contract, the parties shall makeevery effort to resolve amicably such dispute or difference bymutual consultation.

27.2 If, after thirty (30) days, the parties have failed to resolvetheir dispute or difference by such mutual consultation, theneither the Purchaser or the Supplier may give notice to theother party of its intention to commence arbitration, ashereinafter provided, as to the matter in dispute, and noarbitration in respect of this matter may be commencedunless such notice is given.

27.2.1 Any dispute or difference in respect of which a noticeof intention to commence arbitration has been givenin accordance with this Clause shall be finally settledby arbitration. Arbitration may be commenced priorto or after delivery of the Goods under the Contract.

27.2.2 Arbitration proceedings shall be conducted inaccordance with the rules of procedure specified inthe SCC.


27.3 Notwithstanding any reference to arbitration herein,

(a) the parties shall continue to perform their respectiveobligations under the Contract unless they otherwiseagree; and

(b) the Purchaser shall pay the Supplier any monies duethe Supplier.

28. Limitation of 28.1 Except in cases of criminal negligence or willful misconduct,Liability and in the case of infringement pursuant to Clause 7,

(a) the Supplier shall not be liable to the Purchaser,whether in contract, tort, or otherwise, for any indirector consequential loss or damage, loss of use, loss ofproduction, or loss of profits or interest costs, providedthat this exclusion shall not apply to any obligation ofthe Supplier to pay liquidated damages to the Purchaserand

(b) the aggregate liability of the Supplier to the Purchaser,whether under the Contract, in tort or otherwise, shallnot exceed the total Contract Price, provided that thislimitation shall not apply to the cost of repairing orreplacing defective equipment.

29. Governing 29.1 The Contract shall be written in the language specified in theLanguage SCC. Subject to GCC Clause 30, the version of the Contract

written in the specified language shall govern itsinterpretation. All correspondence and other documentspertaining to the Contract that are exchanged by the partiesshall be written in the same language.

30. Applicable Law 30.1 The Contract shall be interpreted in accordance with the lawsof the Purchaser's country, unless otherwise specified in theSCC.

31. Notices 31.1 Any notice given by one party to the other pursuant to thisContract shall be sent to the other party in writing or bycable, telex, or facsimile and confirmed in writing to theother party's address specified in the SCC.

31.2 A notice shall be effective when delivered or on the notice'seffective date, whichever is later.

32. Taxes and Duties 32.1 A Supplier supplying Goods from abroad shall be entirelyresponsible for all taxes, stamp, duties, license fees, and other


such levies imposed outside the Purchaser's country.

32.2 A Supplier supplying Goods offered locally shall be entirelyresponsible for all taxes, duties, license fees, etc., incurreduntil delivery of the contracted Goods to the Purchaser.

81

SECTION V. SPECIAL CONDITIONS OF

CONTRACT

82 Section V. Special Conditions of Contract

NOTES ON THE SPECIAL CONDITIONS OF CONTRACT

Similar to the Bid Data Sheet in Section 11, the clauses in this Section V are intendedto assist the Purchaser in providing Contract-specific information in relation tocorresponding clauses in the General Conditions of Contract (GCC).

The provisions of Section V complement the GCC included in Section IV, specifyingcontractual requirements linked to the special circumstances of the Purchaser, thePurchaser's country, the sector, and the Goods purchased. In preparing thissection, the following aspects should be checked:

(a) The correct version of the Special Conditions of Contract must be usedas a base, dependent upon the type of Goods being procured.

(b) Information that complements provisions of Section IV, GCC, must beincorporated

(c) Amendments and/or supplements to provisions of Section IV, GCC, asnecessitated by the circumstances of the specific purchase, must alsobe incorporated.

Section V. Special Conditions of Contract 83

TABLE OF CLAUSES

1. Definitions (GCC Clause 1) ............................................ 852. Application (GCC Clause 2) ............................................ 853. Country of Origin (GCC Clause 3) ........................................... 864. Standards (GCC Clause 4) ........................................... 865. Use of Contract Documents and Information (GCC Clause 5) ................................ 866. Certification of Goods in Accordance with Laws of the Purchaser's Country

(GCC Clause 6) ....................................... 867. Patent Rights (GCC Clause 7) ........................................ 878. Performance Security (GCC Clause 8) ....................................... 879. Inspections and Tests (GCC Clause 9) ........................................ 8710. Packing (GCC Clause 10) ....................................... 8711. Delivery and Documents (GCC Clause 11) ....................................... 8812. Insurance (GCC Clause 12) ....................................... 9013. Transportation (GCC Clause 13) ....................................... 9014. Incidental Services (GCC Clause 14) ....................................... 9015. Warranty (GCC Clause 15) ........................................ 9016. Payment (GCC Clause 16) ....................................... 9117. Prices (GCC Clause 17) ....................................... 9318. Change Orders (GCC Clause 18) ....................................... 9319. Contract Amendments (GCC Clause 19) ....................................... 9320. Assignment (GCC Clause 20) ....................................... 9321. Delays in the Supplier's Performance (GCC Clause 21) ....................................... 9322. Liquidated Damages (GCC Clause 22) ....................................... 9323. Termination for Default (GCC Clause 23) ....................................... 9424. Force Majeure (GCC Clause 24) ....................................... 9425. Termination for Insolvency (GCC Clause 25) ....................................... 9426. Termination for Convenience (GCC Clause 26) ........................................ 9427. Settlement of Disputes (GCC Clause 27) ........................................ 9428. Limitation of Liability (GCC Clause 28) ....................................... 9629. Governing Language (GCC Clause 29) ........................................ 9630. Applicable Law (GCC Clause 30) ........................................ 9731. Notices (GCC Clause 31) ....................................... 9732. Taxes and Duties (GCC Clause 32) ....................................... 97

Pharmaceuticals .. 9911. Delivery and Documents (GCC Clause 11) .99

Vaccines .. 10111. Delivery and Documents (GCC Clause 11) .10115. Warranty (GCC Clause 15) .................. 101


Condoms ................................. 103

9. Inspections and Tests (GCC Clause 9) ................................. 1031 1. Delivery and Documents (GCC Clause I 1) .103


Special Conditions of Contract

.The following Special Conditions of Contract shall supplement the General Conditions ofContract. Whenever there is a conflict, the provisions herein shall prevail over those in theGeneral Conditions of Contract. The corresponding clause number of the GCC is indicatedin parentheses.

[Instructions for completing the Special Conditions of Contract are provided as needed in

Ethe notes in italics mentionedfor the relevant SCC. Where sample provisions are furnished,

they are only illustrative of the provisions that the Purchaser should draft specifically for

each procurement.]

1. Definitions (GCC Clause 1)!.-- ........-- ......... ..... . .... -.- -- .-.- ..-... ..... ...... ...... _._ ...... .... .._._.._... ._ ... .... .. ....... . . _ ... ... . ..... .._.... ... ._.. ..... ............ _ ..... , .... GCC 1.1 (g) The Purchaser is: [ insert: name of Purchaser .

GCC 1.1 (h) The Purchaser's country is: [insert name of Purchaser's country].

i....... .. . . ... .. ...... .. .... . .. .... ... -.. ... .. ... .. . .... ...... ..-. ........ ... . ........ - . .... ...... .. .... .. .... . ... .. ...

GCC 1.1 (i) The Supplier is: [insert. name of Supplier J.. ......... .............. .. ....... .... .... . ... ... ... .......... .... . .......... .... ....... .......... ..... ................. . ..... ....... . ........... ....... .. . ........ .... .......... ........ ... ..... .. ............ ............ ...... . .. ................. ... . ............. .... ....

GCC 1.1 (k) The Site is/are: [insert, if applicable: identity of Site, street address

and city, or insert: "as specified in the Schedule ofRequirements"].

GCC 1.1 (m) The end user is: [insert, if applicable: the organization(s) stated in

the Schedule of Requirements, where the Goods will be

installed or usedJ.

........................... ........................ ............. ..... ..... ... ........ .... ........ ....... .................. .. . ................ ......... . ............. .... . ......... .. ....... ..... .. .. . ... .. ......... ......... .. ... . .......

2. Application (GCC Clause 2)...................... ...... .... . .. ..... ............ ...... ... ..... ........ ... ..... .. ...... ... ........... . ...... ......... .. ..... .. ......... .. ..... .......... .... ...... ........... .... .... ........... ... ...

GCC2 [insert: necessary and appropriate clauses, or state: "There are no

Special Conditions of Contract applicable to GCC Clause 2. " ]

..................... ...... ... ..... . .......... ......- ...... .... . .......... .. ......... ... .......... ..... . . ....... ... .... ........... .. ....... ... ... ... ... ... .......... ....... .............. .. ...............................


3. Country of Origin (GCC Clause 3)

.. ......... ...... ..... .. ... .. .. ............... ....... ......... ............ ............... ....... .... ........... ........... . ............ ....... . ...... ...... ............ ......... . ....... .... .......... .............. ....... ................... ...... ..... ...... ........ ... ....... . ..... . ...... .. ... . . ................

GCC 3.1 The Bank maintains a list of countries whose Bidders, Goods, and

Services are not eligible to participate in procurement financed

by the Bank. This list is updated regularly, and it is available

from the Public Information Center of the World Bank. A copy

of this list is contained in the section of the Bidding Documents

entitled "Eligibility for the Provisions of Goods, Works, and

Services in Bank-Financed Procurement."

............. ... .............. .... .... .... ... ............................ . ..... .............. .............. ........ .... ............... . . .................. . . ..... . ...... .... ........ ... ................... ............ ... ......... ..

4. Standards (GCC Clause 4)

...... .......... ....... ....... .... . . ....... ......... ... .. .... .......... ....... ........ .. .... .... .... . ........... .. . .... ..... .. .. ....... . ..... .............. . .......... . .. .............. ........ . .. ....... .. ...... . .... ...... . .. ..... ... ........ . ......... .... .......

GCC 4 [insert: necessary and appropriate clauses, or state: "There are noSpecial Conditions of Contract applicable to GCC Clause 4."

~~~~~~~~~~~~............... ....... ......... ..... .... . .. .. . .. . ...... ...... .. ... ...... ..... . ...... .. .. ....... .......... ..... ...... .... ...... ... .. . ....... .. .... .. .............. ...... . .. ....... ... ........ .. ............. ... .......... ....... . ....... ......... ..

5. Use of Contract Documents and Information (GCC Clause 5)

... ....... .......... .... .... ... ......... .. ... -..... .... ......... . .. ........ . .... ......... ...... ....... . .... .. ...... .......... .......... .... ........ ... .......... ..... ....... ......... . ..... ...... ...... ......... .... ......... ..................... ...... . ......... ....... . ............ ......

GCC 5 [insert: necessary and appropriate clauses, or state: "There are noSpecial Conditions of Contract applicable to GCC Clause 5."]

~~~~~~~~~~~~~~~.... . .... .. ...... . .. ........ ................. .......... .. .... . ..... ........... ... ..... .. .......... ... . ... ....... .... ... ...... .. ........ . .... .............. ............... .. ....... ... ... ........ . ....... ........ .............. . ........... ............. . ....... ...... .......... .

6. Certification of Goods in Accordance with Laws of the Purchaser's Country(GCC Clause 6)

..................~~~~~~ ........... ... .. ......---- ................. ............... .......... ........ .. ................... . .... .. .......-.. - ................ ......... .......- ....... . .............. ..._............ ..... .... ....................... ... ... ...

GCC 6.1 [ insert: details of registration and other certification necessary toprove registration in Purchaser's country. j

.... ........ ... . ........ ... . .... ......... ..... ........ .. ..... .. ...... ... .......... ... ... . .......... .... .. .............. ....... .... ................ .. . ........... .................... . ...... ........ . ..... ... . ... ..... .................... ......... .... .......... .. .. ............. ...... .......... ................

GCC 6.2 The Effective Date of the Contract is [insert: date of Contract signingif EITHER: (i) the Goods have already been registered at thetime of Contracting signing OR (ii) registration of the Goods isnot a requirement under the Applicable Law. Otherwise, deleteand insert "NOT USED."]

... .... ........ .. .............. .............. . .... . .......... .... .. ... ... ......... . ............ ........ ..... ..... .. ....... .. ........... ..... ...... .. ... ... . ....... ................. ...... ..... ....... .. ............ ..- .... ..... ... ... .- .... .. . ...... ........ ............. . . . ....

GCC 6.3 The time period shall be [ insert: a number greater than 30] days.[If not used, delete and insert "NOT USED."]

.- ......... ........ . . ..... ...... . ..... ..................... . ... . . ... .. . . ....................... .......... ....... ...... ..... ....... ...........-............


7. Patent Rights (GCC Clause 7)i .. ... ... ............... ....... .. ...... ... ........ .... ........... ................................... .................... ............................I.... ............................................................ .. ............................................................... ..........

GCC 7 [insert. necessary and appropriate clauses, or state: "There are no ISpecial Conditions of Contract applicable to GCC Clause 7."]

8. Performance Security (GCC Clause 8). ..... ................ .... ....... ... .... ... ....... .. ...... ..... .. ............ ...... .. . ..... ..I...... .................. .............. .. ... ........I.. ........... ... . ................ ........... .................. ------- -...............

GCC 8.1 Performance security shall be for an amount equal to [insert: nuber]

Note: Five (5) to ten (10) percent of the Contract Price is areasonable amount.

. ... ... ................ ........ ........ ......... ..... . . ... ........ ... .......... ......... .... .......... .... ... .......................... ........... .................... ... .............. ....... ......... ...... ........ ...... ............ .... ...... . ........ . ..................

GCC 8.4 [insert. any additional requirement related to the discharge of the :performance security, or state: "There are no Special,.Conditions of Contract applicable to GCC Sub-Clause 8.4."]

.................. ............. ........ ...... ..- .. ........... ... ;... .... ......... ..... . ........ .... .................. .. ......... ... ...... .. . .. ........ .. ..... . ... ..... . ...... ....... ............... ............... ...... ..... .. ......... ........ ..... ... ...

9. Inspections and Tests (GCC Clause 9).... ... .. .... .... ................... ....... ........... . . .... . . ...... ....... ........... . . .......... . ....... ....... .. ............. ... .. .... .. .... ....... .. .. ................. ... ........... ... ....... ... ... ........ ... ....... .................... . .......... ..... ...... .GCC 9.1 [insert: any additional requirement related to the inspections and

tests, or state: "There are no Special Conditions of Contractapplicable to GCC Sub-Clause 9."]

... . ..... ~~~~~~~~~~~~....... ....... .... . ............. ...... ..... . . ...... ... ....... ...... . ........ . ..... .......... ..... ......... ........... . ..... . . . .............. ...... .. ........................ ............ ......... ... ...... . ................... . ....... . .. ....

10. Packing (GCC Clause 10)

GCC 10.2 [ insert: any necessary additional requirements with respect topacking and marking or state that additional requirements areindicated in the Technical Specifwcations. I


,. ...... ............. ... ...... ......... . ............ .. ............. ...................... ................. ......... . ..... ...... ..... ... .... -...... ...... . ....... ..... .... .... . ............. .. ..... ..... ........ ......... ........ ... ............. ................................ ........ .. ...... ..... .. ....

11. Delivery and Documents (GCC Clause 11).. ...... .... ....... .... .. .............. .... ..... ..... ... .... ............... . ............ .... .. .............. ........ .... ..... ..... ........ ..... ...... ....... .. ..... ..... .......... ....... .......... ................. ..... .............. ............................ ..... .. . . ..

GCC 11.1 & 11.3 Sample provision (CIF/CIP terms)

For Goods suppliedfrom abroad:.

Upon shipment, the Supplier shall notify the Purchaser and theinsurance company in writing the full details of the shipmentincluding Contract number, description of the Goods, quantity,date and place of shipment, mode of transportation, and estimateddate of arrival at place of destination. In the event of Goods sentby airfreight, the Supplier shall notify the Purchaser a minimumof forty-eight (48) hours ahead of dispatch, the name of thecarrier, the flight number, the expected time of arrival, and thewaybill number. The Supplier shall fax and then send by courierthe following documents to the Purchaser, with a copy to theinsurance company:

(i) three originals and two copies of the Supplier's invoice,showing Purchaser as [ enter correct description ofPurchaser for customs purposes]; the Contract number,loan number, Goods description, quantity, unit price, andtotal amount. Invoices must be signed in original, stamped,or sealed with the company stamp/seal;

(ii) one original and two copies of the negotiable, clean, on-board through bill of lading marked "freight prepaid" andshowing Purchaser as [enter correct name of Purchaserfor customs purposes and Notify Party as stated in theContract, with delivery through to final destination as perthe Schedule of Requirements and two copies of non-negotiable bill of lading, or three copies of railwayIconsignment note, road consignment note, truck or airwaybill, or multimodal transport document, marked"freight prepaid" and showing delivery through to finaldestination as per the Schedule of Requirements;

(iii) four copies of the packing list identifying contents of eachpackage;

(iv) copy of the Insurance Certificate, showing the Purchaser asthe beneficiary;

(v) one original of the manufacturer's or Supplier's WarrantyCertificate covering all items supplied;

..... ........................................... ................... ......... ... . .................... ....... .. ... . ............ ........ _ .. ............ ............ . ........... .. .....-- --.... ......... .......... . .......... ...... .. ............... .......... .......................... .......... ..


(vi) one original of the Supplier's Certificate of Origin coveringall items supplied;

(vii) original copy of the Certificate of Inspection furnished to.Supplier by the nominated inspection agency and six copies(where inspection is required);

(viii) any other procurement-specific documents required fordelivery/payment purposes.

i For Goodsfrom within the Purchaser's country:

. Upon or before delivery of the Goods, the Supplier shall notify theI Purchaser in writing and deliver the following documents to the

Purchaser:

(i) two originals and two copies of the Supplier's invoice,showing Purchaser, the Contract number, loan number;Goods' description, quantity, unit price, and total amount.Invoices must be signed in original and stamped or sealedwith the company stamp/seal;

.. j (ii) two copies of delivery note, railway consignment note,road consignment note, truck or air waybill, or multimodaltransport document showing Purchaser as [enter correctname of Purchaser for customs purposes] and deliverythrough to final destination as stated in the Contract;

(iii) copy of the Insurance Certificate, showing the Purchaser asthe beneficiary;

(iv) four copies of the packing list identifying contents of eachpackage;

(v) one original of the manufacturer's or Supplier's Warrantycertificate covering all items supplied;

(vi) one original of the Supplier's Certificate of Origincovering all items supplied;

(vii) original copy of the Certificate of Inspection furnished toSupplier by the nominated inspection agency and six copies(where inspection is required)

(viii) other procurement-specific documents required fordelivery/payment purposes.


.... ... .. ... .... .............. ................ . ... ........ . ...... .. ....... ........ ..... ......... .. ...... ... .............. ... ......... .... .................. ......... ........... . ..... ......... ...... . ...-... . .. ............ .. ........ ..... .. ............. ........ ... ..... .................... ............... ....

Note: In the event that the documents presented by the Supplierare not in accordance with the Contract, then payment willbe made against issue of the Acceptance Certificate, tobe issued in accordance with SCC 9 (GCC 9) above.

~~~~~~~~~~~~~~~~~~~~~~~~........ ... ... ..... .... ... ...... ...... ...... ..... ... ............. ......... ........ .... .... .. .............. ..... ..... ......... . ............. .. ........-.. ... ............ ......... .. ................. .... ... ...... .......... ........... .... .. ........................ ...

12. Insurance (GCC Clause 12)

GCC 12.1 The insurance shall be in an amount equal to 110 percent of the CIF orCIP value of the Goods from "warehouse" to "warehouse" on"All Risks" basis, including war risks and strikes (only ifcontract placed on CIF or CIP basis).

~~~~~~~~~~. ... ... . .... ..... ...... .... ......... ...... ..... ........ .......... ............. ..... . ....... -.... .... ............. . ................ ... .... . .......... .. ...... .... . . . . .. ........ .. .... ......... ..... ........ . ..... .......... .... . ......

13. Transportation (GCC Clause 13).... ....... .......... .......... ......... .................. ... ... .......... .......... ..... ...... ........ . ........................ . ............... .. ...... . .... ... . . ......... .. .... ...... . ... ..................... . .. ........... ...... ............... . ... . .......... ......... .. ...... .. .... ... ......... .... .

GCC 13 [insert: necessary and appropriate clauses, or state "There are noSpecial Conditions of Contract applicable to GCC 13."]

....... ..... . .. ..... .. ... . .... ... . ......... .. .... ... ..... . ........ ... . .......... ... ........... ......... ... . ............. ..... .... ........ ... ...... ......... .. ........ ... .......... ........... ............ ...... .. . ......... ...... ...

14. Incidental Services (GCC Clause 14),....... .. . ...... ........ ........ .... ... ..... . .. ........ ........ .... .. ..... . .. ............ . ....... . ......... .... ........ ... .......... . .. ............ ............ . .... .. ......................... .. .... ... ... .......... .............. ........ .....

GCC 14.1 Incidental services to be provided are:

[Sample clauses]

(a) The Supplier shall provide all necessary licenses andpermissions for use of the Goods in the Purchaser's countrythat may be required for the Goods. The cost shall bedeemed included in the Contract Price.

(b) The Supplier shall provide such other services as are statedin the Technical Specifications. [ insert: sections of theTechnical Specifications where the services are listed.]

.... .............. ........ .... .... . ........... ............ ..... .... ...... ... ........ . .. ... .......... ... ...... .. ...... ....... . .... - .......... ... .. ... ................ .. ............ . ...... ................ ...... . .. ....... ............ .. .... .......... . ......... ... ........ .....

15. Warranty (GCC Clause 15). .... . . ... . ..... ..................... ... ..... .. .. ....... ...... . ........... .... .. . ...... i. ....... .. .... ..... . .. .......... . .. ... .. ................ .... ................... . ..... ......... ... ...... .... .. ........ ... ...... . ....... . ....... ....... .. . .. ........ ...

GCC 15.1 [insert: necessary and appropriate clauses, or state "There are noSpecial Conditions of Contract applicable to GCC 15."]


.. r.... . - - _. _...... .. -+.-_ ........ . ...... ..... ...... ... ............ ..... ............. _._._._._._._._ -.- ..... . ....... _. _ .._.......... .......... .... _ .. ... +. ._._.__...__ __._..... _.._......._ __ _._._ .._._._...... _._ _._._ ..._.. ... _..,...GCC 15.4 The period for the replacement of defective goods is: [ insert periodfor

replacement of defective goods .

..... . ......... . ....... ...... .. ..... .. ... .. . .. .... ............ .. . . ............... .................. .................... ................................ .... . . ... .... .. . ..... ..... ................ .. ....... ......

16. Payment (GCC Clause 16)... .......-- -- ----...... . .......... .. ........ ..... ....... ..............f. ......... ........ ........ ......... ..-.. ................... ...... ... ........... .. . .. .... .................. .... ............. . ... ......... .. . ........... . .... ...... .

GCC 16.1 & 16.4 [Sample provision]

The method and conditions of payment to be made to the Supplierunder this Contract shall be as follows:

Payment for Goods supplied from abroad:

Payment of foreign currency portion shall be made in [insert: currencyof the Contract Price in the following manner:

(i) Advance Payment: Ten (10) percent of the Contract Priceshall be paid within thirty (30) days of signature ofContract and receipt of the Performance Guarantee, upon isubmission of an invoice (showing Purchaser's name; theContract number, loan number; description of payment andtotal amount, signed in original, stamped or sealed with thecompany stamp/seal) and a bank guarantee in the form-provided in Section VIII, Advance Payment BankGuarantee.

(ii) On Shipment: Eighty (80) percent of the Contract Priceof the Goods shipped shall be paid through irrevocableconfirmed letter of credit opened in favor of the Supplier ina bank in its country, upon submission of documentsspecified in GCC Clause 1 1 or, alternatively, at theSupplier's option, within thirty (30) days of submission ofdocuments specified in GCC Clause 11 above by direct.bank transfer to the Supplier's nominated bank account.Opening charges and charges for amendment of the letterof credit at the request of or due to a fault or default of thePurchaser are for the account of the Purchaser. -

Confirmation charges and charges for amendment to lettersof credit at the request of or due to a fault or default onbehalf of the Supplier are for the account of the Supplier.

(iii) On Acceptance: Ten (10) percent of the Contract Price ofGoods received shall be paid within thirty (30) days ofreceipt of the Goods upon submission of an invoice(showing Purchaser's name; the Contract number, loan.....,...._..... ........ . . ........_...... ........ .................... .. ..... .... ... -... .... .. . ............. ......A......._ ......._... .. ........_. ._.......... ... ........... .... ._. ....... ... ._......... ....... .....,.........._.. ... _...... ....


number; description of payment and total amount, signedin original, stamped or sealed with the companystamp/seal) supported by the Acceptance Certificate issuedby the Purchaser.

Payment of local currency portion shall be made in [insert: currency]

within thirty (30) days of presentation of an invoice (showingPurchaser's name; the Contract number, loan number;description of payment and total amount, signed in original,stamped or sealed with the company stamp/seal) supported by.the Acceptance Certificate issued by the Purchaser.

Payment for Goods and Services supplied from within thePurchaser's country:

Payment for Goods and Services supplied from within the Purchaser'scountry shall be made in [insert: currency], as follows:

(i) Advance Payment: Ten (10) percent of the Contract Priceshall be paid within thirty (30) days of signature ofContract and receipt of the Performance Guarantee, uponsubmission of an invoice (showing Purchaser's name; theContract number, loan number; description of payment andtotal amount, signed in original, stamped or sealed with thecompany stamp/seal) and a bank guarantee in the formprovided in Section VIII, Advance Payment BankGuarantee.

(ii) On Shipment: Eighty (80) percent of the Contract Priceof the Goods shipped shall be paid within 30 days ofsubmission of documents specified in GCC Clause 11above by direct bank transfer to the Supplier's nominated.bank account.

(iii) On Acceptance: Ten (10) percent of the Contract Price ofGoods received shall be paid within thirty (30) days ofreceipt of the Goods upon submission of an invoice.(showing Purchaser's name; the Contract number, loannumber; description of payment and total amount, signedin original, stamped or sealed with the companystamp/seal) supported by the Acceptance Certificate issuedby the Purchaser.

[Please note that percentages may be changed to meet.procurement specific requirements or trade norms.]

.. ..... .... . .... .......... .. ...... .. .... ............ ...... ........ ... ...... . .-.. ..... .. . . ........ ..... .......... ............ ... .... ....... ..... ......... .- 1 ........ ... ............... .. ....... ........... .... .. ...... .. .............. . ...... ......... .... .... ...... .. .........


. .......... ... ............... ..... ..... ....... .......................... . ............. ........ ....... . ................ .. .............. ... ... .-. .... . . ..... _ ........ ...... ..... . . ...

17. Prices (GCC Clause 17)

GCC 17.1 [Sample provision]

Prices shall be fixed and firm for the duration of the Contract.

..... .... . .... .... .............. .. .. . ... .... .. .............. ..... .................. ........ .. ................ .................. .. . .. . ............... .... ........ ....... .... .... . ... . .... . . .- . -. . .. .. .... ... _. .... _. _...... _._ .-_.

18. Change Orders (GCC Clause 18)

GCC 18 - [insert: necessary and appropriate clauses, or state "There are noSpecial Conditions of Contract applicable to GCC 18."]

......... ...... .. ... . .. .. .. . ......... ...... ..............-. .. .. .. .. ...... ...................... . . ............ . .. . .. .-.............................. . .. .. . ... . ...... . . ... . .. .. ... .. .. ...... ..

19. Contract Amendments (GCC Clause 19)

-GCC 19 [insert: necessary and appropriate clauses, or state "There are noSpecial Conditions of Contract applicable to GCC 19."]

. ....... ........ .................... ...................... . ... . ..... ..... ................ . .... ..... .......... ...... .............. .......... _-..-... . . . --. -. -.. . __ .. . . .. ...

20. Assignment (GCC Clause 20)

GCC 20 , [insert: necessary and appropriate clauses, or state "There areSpecial Conditions of Contract applicable to GCC 20."]

,... .... . .. ..........-... .... -.. ....-... ................................... -.. ... .. .-- .... - -.-.--.-.-- -.-.--- --.-------. .-.-.--..- - .-. .-. -.

21. Delays in the Supplier's Performance (GCC Clause 21). ............................... ................................. ....... ........... ........... . . .... . .. . ...... .. ........... . . . . ...-. .

GCC 21 i [insert: necessary and appropriate clauses, or state "There are noSpecial Conditions of Contract applicable to GCC 21."]

_ ._ .___._ _.__.._.._. ........ .. . .... _._._ ... _..... . _._ .._._._._... _. _._. ...... .. . ...... . . _.._.... ._. _.._.... ..... ..... .. _. . .. ...... _..... ..... _......_._...... . .. . .. . . ._... . .. . ... . _ .. .... .. .. ... . . . .. . ..........

22. Liquidated Damages (GCC Clause 22)

GCC 22.1 - insert: applicabe rate]

[insert maximum deduction]


........ . ... ....... ... ..... .... ..... ...... . ........... . ...... . .. ....... . ......... ........................... ..... .......... ......... ............. .. ................ ............... - .... ... ....... -.... . .

Note: Applicable rate shall not exceed one-half (0.5) percent perweek, and the maximum shall not exceed ten (10) percentof the Contract Price.

..... ...... ............... . .... .......... ..... .... .......... .. ................... ............... ...... .. ......... ....... ........ ........ ........... ........... .................... . ............... . .... . .. .... ..........................................

23. Termination for Default (GCC Clause 23). ----- . ----- ..... .. ........ .... ..... ...... ..... ....... .. ... ........ ... . ....... ... ... ...... ........ . ............ ...... . ....... . ........... ....... ... . .......... .............. .... ..... .... ............. ......... .. ..... ... ................................................................... .........................


.............. .... .. .... ......... . ........... ..... . ... ..... ........... ... ................. ... ........ . ........... ......... .......... .. ......... . . .. .... ... ... .. ... .. ........ ... ... .. ....... ... ...... ... ....... .......... ... ........... ... .................... ...

24. Force Majeure (GCC Clause 24)......... ..... ............................................ .. . ........... ......... .... ......... ............. ... .... ......... ....... . .......... . . ......... ......... ............. ...... ...... ....... ...... ........ ..... .. . ... ........... .............. ...... ... ............ .. ............

GCC 24 [insert: necessary and appropriate clauses, or state "There are noSpecial Conditions of Contract applicable to GCC 24."

........ .... ...... . . . ..... ..................... ... ....... . .. . ..... . ......... .......... ....................... . . . ........... . .. ............ ... ... ............ ... ... .......... ... ........... .. ...... .... ... ... ..... .... ...... . .... ........ ....... .. .............. . ..... ....... ....... ... .......... ........ ... .................... .....

25. Termination for Insolvency (GCC Clause 25).... .. ...... .......... .......... ........ .......... ......... .............. ............ ...... ... ....... ... .... ... . ............... ..... ...........

GCC 25 insert: necessary and appropriate clauses, or state "There are noSpecial Conditions of Contract applicable to GCC 25."]

........ . ... ........ ..... .. ........ ... .................... ...... ........ ........... ... . . ........ . .... .... ....... ........ ........ .... ...... ......... .. ............... ..... ........ ....... .............. . ........ ..... ..... .... .... . ..... .... ...........

26. Termination for Convenience (GCC Clause 26)


........ ........... ............................................... .... .......... ...... .... ..................... ............ .. . ... ................. . .......... ...I .. ........ ............ . .. ............ ... ............... ....... ........... ................. .... ..

27. Settlement of Disputes (GCC Clause 27)...... . ................. ........ ....... ....... .......... ......... . ....... . ........ .... ..... ........... ... ... .... ....... .... .......... .... ......... .. . .. ........ ... ..... ..... .. ... ....... . ...... .............. ....... .......... ... ........

GCC 27.2.2 The dispute resolution mechanism to be applied pursuant to GCC Sub-Clause 27.2.2 shall be as follows:

(a) Contracts with foreign Supplier:

[For Contracts entered into with foreign Supplier,International commercial arbitration may have practical

........... ........... ................................................. . .. ......... ..... .................. ............ . ........... ....... .... ......... .. .. .. ......... . ......... ...... ............ ........ ........ .. ............ ............ .... . . ....... ............ . .. ........... ............


._~~~~~~~~~~~~~~~~~~~~~~~ -- ... ..... - ... - -- - ---- ------- - --------- ---------- ---- ... ......_.__._........._.. ......... ....................... .......... _.. ..... .... .advantages over other dispute settlement methods. TheWorld Bank should not be named as arbitrator, nor shouldit be asked to name an arbitrator. Among the rules to;govern the arbitration proceedings, the Employer may wishto consider the United Nations Commission onjInternational Trade Law (UNCITRAL) Arbitration Rules of

!j 1976, the Rules of Conciliation and Arbitration of theInternational Chamber of Commerce (ICC), the Rules of the

j London Court of International Arbitration or the Rules ofArbitration Institute of the Stockholm Chamber ofCommerce.]

If the Purchaser chooses the UNCITRAL ArbitrationRules, the following sample clause should be inserted:

GCC 27.2.2 (a)-Any dispute, controversy, or claim arisingout of or relating to this Contract, or breach, termination orinvalidity thereof, shall be settled by arbitration inaccordance with the UNCITRAL Arbitration Rules as atpresent in force.

If the Purchaser chooses the Rules of ICC, the followingsample clause should be inserted:

GCC 27.2.2 (a)-All disputes arising in connection with thepresent Contract shall be finally settled under the Rules ofConciliation and Arbitration of the International Chamber ofCommerce by one or more arbitrators appointed in.

I, accordance with said Rules.

If the Purchaser chooses the Rules of Arbitration Instituteof Stockholm Chamber of Commerce, the followingsample clause should be inserted:

GCC 27.2.2 (a)-Any dispute, controversy, or claim arisingout of or in connection with this Contract, or the breach,termination, or invalidity thereof, shall be settled byarbitration in accordance with the Rules of the Arbitration,Institute of the Stockholm Chamber of Commerce.

If the Purchaser chooses the Rules of the London Court ofInternational Arbitration, the following clause should beinserted:

GCC 27.2.2 (a)-Any dispute arising out of or in connection|...~ ..L.. ,... with this Contract, including any question regarding its...__.__.______._._.___.__._ __ _._._._._____._._.__ .__._. _ . ._._._._.__.___. - ---- ....... __._._._ --------


existence, validity, or termination shall be referred to andfinally resolved by arbitration under the Rules of the.London Court of International Arbitration, which rules aredeemed to be incorporated by reference to this clause.

(b) Contracts with Supplier national of the Purchaser's

country:

In the case of a dispute between the Purchaser and aSupplier who is a national of the Purchaser's country, thedispute shall be referred to adjudication or arbitration inaccordance with the laws of the Purchaser's country.

[The bidding documents should contain one clause to be

retained in the event of a Contract with a foreign Supplier

and one clause to be retained in the event of a Contract with

a Supplier who is a national of the Purchaser's country. At

the time offinalizing the Contract, the respective applicable

clause should be retained in the Contract. The following

explanatory note should therefore be inserted as a header to

SCC 2 7.2.2 in the bidding document.

"Clause 27.2.2 (a) shall be retained in the case of a

Contract with a foreign Supplier and Clause 2 7.2.2 (b) shall

be retained in the case of a Contract with a national of the

Purchaser's country."]

28. Limitation of Liability (GCC Clause 28).............. . ........ .... ..... .... . ................. ....... ......... . ............ ......... ............ .. ........ ...... . ....... ...... ....... .......... .... ....... ......... .. ......... ..... .......... ... ..... ..... ..... .......... . ......... ......... ..... ........ ....... ...... ............... .

GCC 28 [insert: necessary and appropriate clauses, or state "There are no

Special Conditions of Contract applicable to GCC 28."]

29. Governing Language (GCC Clause 29).... ................ . ......... .. ........ . ................. ... ............ . ......... .. . . . ......... ....... .......... .. ....................................... ............. ..... ......... ....... ... ... .... ...... ............ ....... .......... ............. . .....................

GCC 29.1 insert: the governing language]

................ . . . .. . . [ i : g ..............................o. ...... .................................................................................. ... ....................... ............... ... ....


30. Applicable Law (GCC Clause 30)

GCC 30.1 The Contract shall be interpreted in accordance with the laws of the:[insert: name of country ].

31. Notices (GCC Clause 31)

GCC 31.1 [insert: the Purchaser's addressfor notice purposes]

[insert: the Supplier's address for notice purposes]

~~~~~~~~~~~............. ... .... .- -..... ..... ........ . . . .. .. . .. .. .. . .. ... .. . .. . .. .... . .... ..... ........... ........ ... .... . ... .. . ....................... ........ .... ............ ...... .................. ......... ........... .................

32. Taxes and Duties (GCC Clause 32)

GCC 32 [insert: necessary and appropriate clauses, or state "There are no

Special Conditions of Contract applicable to GCC 32."]

99


PHARMACEUTICALS(Additional Clauses)

The below data should be included in the Special Conditions of Contract used in BiddingDocuments for the procurement of pharmaceuticals.

11. Delivery and Documents (GCC Clause 11)........... ....... ................. ................ .......... ............ ....... .......................... .................. ....... .. - . ...... ..... -... ... ... . ... ..... . ... .... ........... ......... ............. . ....... . ................. .......... ... .... .

GCC 11.1 & 11.3 For Goods suppliedfrom abroad:

(ix) One original of the Certificate of Pharmaceutical Product asrecommended by the WHO for each of the items supplied.

(x) Certificate of quality control test results in conformity withthe World Health Organization "Certification Scheme on theQuality of Pharnaceutical Products Moving in InternationalTrade" stating quantitative assays, chemical analysis,sterility, pyrogen content, uniforrnity, microbial limit, andother tests as appropriate to the Goods.

(xi) Original copy of the certificate of weight issued by the portauthority/licensed authority and six copies.

. ..~~~~~~~~~~...

.... . ..... . .. . .. . .... . . ... ..... . . .. . ...... ... . ..... ...... ...... .... . ... . . . ......

101


VACCINES(Additional Clauses)

,... . ...... .... .....I. . .......... . ... ..... .. ..... ...... .......... ........ ...... ... ....... ........ .. ..... -- . .... ....... ........ .. . ... .. ..........I... .. ................ ......... ... .................. ... .... ................ ............. ............ ...........The below data should be included in the Special Conditions of Contract used in BiddingDocuments for the procurement of vaccines.

........ ~~~~~~~~~~. ... .. ....... .... ............. ... ... ... ....... .. .. ... .... ......................... .... . ....... ...... .......... .. ...... .... . .... . .. ....................... ............. ....... ... ............. ........ ................ .

11. Delivery and Documents (GCC Clause 11)

GCC 11.1 & 11.3 For Goods supplied from abroad:

(ix) one copy of the Lot Release Certificate issued by the NCAof the country of manufacture for each lot shipped.

(x) Certificate of quality control test results in conformity withthe World Health Organization "Certification Scheme on theQuality of Pharmaceutical Products Moving in InternationalTrade" stating quantitative assays, chemical analysis,sterility, pyrogen content, uniformity, microbial limit, andother tests as appropriate to the Goods.

(xi) Original copy of the certificate of weight issued by the portauthority/licensed authority and six copies.

For Goods from within the Purchaser's country:

(x) one copy of the Lot Release Certificate issued by the NCAof the country of manufacture for each lot shipped.

....... ... ...... ..... ...... . ... . . ........ ... . .... . .. . ......... .. ... .. ........ .. .. ........ ... _.._ ....... .. ........ . ........ .. ........... . ... . .... ... _ .. . _. .....

15. Warranty (GCC Clause 15),...... . .. .. . ... ... ..... ....... ............ ...... .. .. ....... .. .... ..... ... .. ......................... ... . .. ......... ................................... ....... ............ ...... ...... . . .. ..... . ............ ......... ... .......... ............. . .......... . ......... ...... ................ ..... -.. ........GCC 15.1 [Sample clauses]

The Purchaser reserves the right to request evidence of bio-availability and/or bio-equivalence data and/or evidence of thebasis for expiration dating and other stability data concerning theGoods to verify shelf life claimed for the Goods.

,..... .... .......... .. ....... . .... . ............ .. ..... ..... ..... . ... ................... ... ....... . ........ .. . . .......... .. ........ ......... . .......... - - ... ... .. ......... . .......... . . .................. ... ..... .. . .. .... .............. .... .......... 1... ....... .. .....

102 Section V. Special Conditions of Contract - Vaccines (Additional Clauses)

.............. . . . ........ .................. .......................... ...... .......................... .. ....... . ....... . ......- .............-.. ... . ... .….. ........ ...... . .. .... .

If an adverse event following immunization (AEFI) occurs in thePurchaser's country and the cause of such event cannot beimmediately established, the Purchaser will, with all urgency andin accordance with the procedures laid down by the NCA of thePurchaser's country, take steps to advise the Supplier in orderthat an investigation may be launched immediately. If the Ivaccine has been supplied through an agency of the UnitedNations, the most current procedures laid down by the WHO forsuch situations will be used.

.. ......... ... ....... ..... ... .... ......... .. .i.... .... ....... .... .......... . ......... .... .......... ............ ........ ........ . ... ........ .. . ........ ................ ... ............ ........... .. ...... . ....... ... ...... ... .......... . .. ...... . ............... ..........

103


CONDOMS

The following Special Conditions of Contract shall supplement the General Conditions ofContract in the procurement of condoms. Whenever there is a conflict, the provisions hereinshall prevail over those in the General Conditions of Contract. The corresponding clausenumber of the GCC is indicated in parentheses.

9. Inspections and Tests (GCC Clause 9)

GCC 9 (e) The Supplier shall test batches of Goods ready forshipment in accordance with the WHO specification. Thesize of the sample for testing will be calculated byreference to IS02859-1. With each consignment, theSupplier must provide a certificate of quality control testresults in conformity with the standards laid down in ISO2859-1 and in accordance with the general sampling levelsappropriate to each feature as necessary. The Supplierwill bear the cost of such tests.

11. Delivery and Documents (GCC Clause 11)

GCC 11.1 & 11.3 For Goods suppliedfrom abroad.

(ix) original copy of quality control tests for each consignment asstated in SCC 9 above.

(x) original copy of the certificate of inspection furnished toSupplier by nominated inspection agency and six copies[where separate inspection is required].

For Goods from within the Purchaser's country:

(ix) certificate of in-house analysis.

.. .. ..... . ...... .. .. . . . . .. . . .. ... ... . .. ... . ... ... . .. ..... .. .. . ..... ... ...... . .... . . ........- ... ...... . ........ ...... . .

105

SECTION VI. SCHEDULE OF REQUIREMENTS

106 Section VI. Schedule of Requirements

NOTES FOR PREPARING THE SCHEDULE OF REQUIREMENTS*, ._ WW.J# i ftdlt V .*...,_ t=..At*t W

The Schedule of Requirements provides a concise description of each product andthe quantity required, along with any technical specifications unique to that item. If itcan be printed with sufficient space for Suppliers to enter offers, having Suppliersuse this space for bids greatly simplifies the collation of offers. Sufficient spaceshould be provided so that the Supplier can enter all relevant information, includingthe name of the original manufacturer.

The Schedule of Requirements should include the international nonproprietaryname (INN) or generic name (for combination product, the name of each genericcomponent), the strength in metric units for each component, the basic unit (tablet,capsule, vial, bottle), the package size, and the number of packages needed. SomeSchedules of Requirements list both the total number of packages and the totalnumber of basic units needed, to avoid misunderstanding and to allow for thepossibility that a Supplier may offer a different (but acceptable) package sizerepresenting the same number of basic units. The schedule of requirements shouldspecify whether the listed package sizes are the only ones acceptable.

The delivery schedule expressed as weeks stipulates hereafter a delivery date thatis the date of delivery (i) at EXW premises or (ii) to the carrier at the port of shipmentwhen the Contract is placed on FOB or CIF terms or (iii) to the first carrier when theContract is placed on FCA or CIP terms. To determine the correct date of deliveryhereafter specified, the Purchaser has taken into account the additional time that willbe needed for international or national transit to the site or to another commonplace.,

Number Description Strength Quantity4 Delivery schedule (shipment) Mode ofIn weeks from s Shipment6

3 The delivery may be specified for a single shipment, for several partial shipments, for a specific date, orrange of acceptable delivery periods.

4 If the quantity required is very large, and competition is likely to be very restricted because of lack ofmanufacturing capacity, the Purchaser may decide at the time of preparing Bidding Documents to dividethe required quantities into more than one lot. However, as far as practical, the size of lots should be forcomparable quantity and the number of lots should normally not be more than three. The BDS shouldindicate whether or not discounts for combined lots will be taken into account for bid evaluation and awardof Contract.

5 The Purchaser must specify here the date from which the delivery schedule will start. That date should bea date not later than the Contract Effective Date and may be the Contract Effective Date itself, the date theletter of credit is opened, or the date of confirmation of the letter of credit, as appropriate. The Bid Formshould include only a cross reference to this Schedule.

6 Delete if both air and sea shipments are acceptable. If some items must be sent only by air shipment, thisshould be specified clearly.

107

SECTION VII. TECHNICAL SPECIFICATIONS

108 Section VII. Technical Specifications

NOTES FOR PREPARING THE TECHNICAL SPECIFICATIONS

[Procurement Specific]t~~ -, k t * , . 0 $ z §u s>x.r@§§mv__H

A set of precise and clear specifications is a prerequisite for Bidders to respondrealistically and competitively to the requirements of the Purchaser without qualifyingtheir bids. The sample text provided in this section should serve as guidance only.This text is not intended to be used verbatim since technical specifications specificto each procurement should be drafted by the Purchaser for inclusion in the biddingdocuments. In the context of international competitive bidding (ICB) among qualifiedfirms, the specifications must be drafted to permit the widest possible competition.The technical specifications establish the requirements for good manufacturingpractices (GMPs), pharmacopoeial standards, nomenclature, and descriptionrequired for each product, shelf life and package expiration date parameters,labeling instructions, packaging instructions, GMP and quality assurance certificatesrequired, and other evidence of product quality to be submitted with the bid and witheach shipment. Only if this is done will the objectives of economy, efficiency, andfairness in procurement be realized, responsiveness of bids be ensured, and thesubsequent task of bid evaluation facilitated.

Specific pharmacopoeial standards should be listed for each product; if any of arange of standards is adequate (British Pharmacopoeia, United StatesPharmacopoeia, European Pharmacopoeia, or International Pharmacopoeia), thisshould be noted. If special packaging or labeling is required for a subset ofproducts, this should be indicated on the schedule of requirements (see above), buta generic statement of packaging and labeling applied to all products should beincluded in the general technical specifications. Instructions about labeling (contentsand language) and package inserts can be included in the technical specifications,unless there are specific requirements for each batch or schedule of requirements.

Section VII. Technical Specifications 109

Technical Specifications

[Text of Technical Specifications to be inserted in the Bidding Documents by the Purchaser,as applicable.]

TECHNICAL SPECIFICATIONS: PHARMACEUTICALS

TECHNICAL SPECIFICATIONS: CONDOMS

TECHNICAL SPECIFICATIONS: VACCINES

111

Sample Technical Specifications

PHARMACEUTICALS

1. Product and 1.1 The Goods to be purchased by the Purchaser under thisPackage Invitation for Bids are included in the Purchaser's currentSpecifications national essential drugs list or national formulary. The

required packing standards and labeling must meet the latestrequirements of the World Health Organization (WHO) goodmanufacturing practices (GMP) standards in all respects.(These standards are contained in "Good Practices in theManufacture and Quality Control of Drugs.")

1.2 Product specifications indicate dosage form (e.g., tablet,capsules, dry syrup, liquid, ointment, injectable, emulsion,suspension, etc.) and the drug content (exact number of mg orinternational units [IU] or % v/v, w/w or v/w acceptablerange). The Goods should conform to standards specified inthe following compendia: [The Borrower should specify anacceptable pharmacopoeia standard from one of the following:the British Pharmacopoeia, the United StatesPharmacopoeia, the French Pharmacopoeia, theInternational Pharmacopoeia, or the EuropeanPharmacopoeia, the latter particularly for raw materials.] Thestandards will be the latest edition unless otherwise stated bythe Purchaser or other if applicable. In case thepharmaceutical product is not included in the specifiedcompendium, but included in the Purchaser's nationalessential drug list, the Purchaser should clearly indicateacceptable limits and the Supplier, upon award of theContract, must provide the reference standards and testingprotocols to allow for quality control testing.

1.3 Not only the pharmaceutical item, but also the packaging andlabeling components (e.g., bottles, closures, and labeling)should also meet specifications suitable for distribution,storage, and use in a climate similar to that prevailing in thecountry of the Purchaser. All packaging must be properlysealed and tamper-proof, and packaging components mustmeet the latest compendium standards and be approved forpharmaceutical packaging by the manufacturer's nationalregulatory authority (RA). The Purchaser should specify anyadditional special requirements.

112 Section VII. Sample Technical Specifications - Pharmaceuticals

1.4 All labeling and packaging inserts shall be in the languagerequested by the Purchaser or English if not otherwise stated.

1.5 Goods requiring refrigeration or freezing or those that shouldnot fall below a certain minimum temperature for stabilitymust specifically indicate storage requirements on labels andcontainers and be shipped in special containers to ensurestability in transit from point of shipment to port of entry.

1.6 Upon award, the successful Supplier shall, on demand,provide a translated version in the language of the bid of theprescriber's information for any specific goods the Purchasermay request.

2. Labeling 2.1 The label of the primary container for each pharmaceutical andInstructions vaccine products shall meet the W210 GMP standard and

include:

(a) The international nonproprietary name (INN) or genericname prominently displayed and above the brand name,where a brand name has been given. Brand namesshould not be bolder or larger than the generic name;

(b) dosage form, e.g., tablet, ampoule, syrup, etc.;

(c) the active ingredient "per unit, dose, tablet or capsule,etc.";

(d) the applicable pharmacopoeial standard;

(e) the Purchaser's logo and code number and any specificcolor coding if required;

(f) content per pack;

(g) instructions for use;

(h) special storage requirements;

(i) batch number;

(j) date of manufacture and date of expiry (in clearlanguage, not code);

(k) name and address of manufacture;

(1) any additional cautionary statement.

Section VII. Sample Technical Specifications - Phannaceuticals 113

2.2 The outer case or carton should also display the aboveinformation.

3. Case 3.1 All cases should prominently indicate the following:Identification

(a) Purchaser's line and code numbers;

(b) the generic name of the product;

(c) the dosage form (tablet, ampoule, syrup);

(d) date of manufacture and expiry (in clear language notcode);

(e) batch number;

(f) quantity per case;

(g) special instructions for storage;

(h) name and address of manufacture;

(i) any additional cautionary statements.

3.2 No case should contain pharmaceutical products from morethan one batch.

4. Unique 4.1 The Purchaser shall have the right to request the Supplier toIdentifiers imprint a logo, if the quantity so justifies it, on the labels of

the containers used for packaging and in certain dosageforms, such as tablets, and ampoules and this will be in theTechnical Specifications. The design and detail will beclearly indicated at the time of bidding, and confirmation ofthe design of such logo shall be provided to the Supplier atthe time of contract award

5. Standards of 5.1 The successful Supplier will be required to furnish to theQuality Purchaser:Control forSupply (a) With each consignment, and for each item a WHO

certificate of quality control test results concerningquantitative assay, chemical analysis, sterility, pyrogencontent uniformity, microbial limit, and other tests, asapplicable to the Goods being supplied and themanufacturer's certificate of analysis.

(b) Assay methodology of any or all tests if requested.

114 Section VII. Sample Technical Specifications - Pharmaceuticals

(c) Evidence of bio-availability and/or bio-equivalence forcertain critical Goods upon request. This informationwould be supplied on a strictly confidential basis only.

(d) Evidence of basis for expiration dating and otherstability data concerning the commercial final packageupon request.

5.2 The Supplier will also be required to provide the Purchaserwith access to its manufacturing facilities to inspect thecompliance with the GMP requirements and quality controlmechanisms.

Section VII. Technical Specifications -Vaccines 115

Sample Technical Specification

VACCINES

1. Product Option A

Qualification 1.1 The Goods to be purchased by the Purchaser under thisRequirements Invitation for Bids must be produced under the control of a

recognized, well-functioning National Control Authority(NCA) for biologicals, which performs all six criticalfunctions as defined by the World Health Organization(WHO):

(a) licensing based on published set of requirements

(b) surveillance of vaccine field performance

(c) system of lot release for vaccines

(d) use of laboratory when needed

(e) regular inspections for good manufacturing practices(GMP)

(f) evaluation of clinical performance

Or state the following:

Option B

1.1 The Goods under this Invitation for Bids should be purchasedfrom WHO-approved sources only.

1.2 The Goods to be purchased by the Purchaser under thisInvitation for Bids must be produced in accordance with theGMP recomrnendations of WHO for biological products.

1.3 The Goods to be purchased by the Purchaser under thisInvitation for Bids must be registered by the NationalControl Authority (NCA) of the Purchaser's country.

2. Product 2.1 Dosage form (e.g.: oral or injectable; liquid or freeze driedSpecifications with sterile diluent packed separately, etc.).

116 Section VII. Sample Technical Specifications - Vaccines

2.2 Type (e.g.: "live attenuated," "manufactured from purifiedinactivated (...) obtained from human plasma ormanufactured using recombinant DNA technology," etc.).

2.3 Administration (e.g.: "intended for intramuscular injection,"etc.).

2.4 Description of intended use (e.g.: "immunization of newborninfants," etc.).

2.5 Dosage size (if not restrictive), or expected immunogenicreaction (e.g.: each dose shall contain that amount of Hbsagprotein with micrograms/ml specified by the manufacturerfor newborn dosage, that when given as part of a primaryimmunization series [3 doses] is capable of producingspecific humoral antibody [anti HBs] at a level of at least 10milli international units in >-90 percent of recipients," etc.).

2.6 Dose package (e.g.: "5 infant dose sterile glass vials," etc.).

2.7 Filling volume (e.g.: "final product should contain 15%overfill," etc.).

2.8 Closures (e.g.: "vaccine vials shall be fitted with closuresthat conform to ISO standard 8362-2").

2.9 Storage temperature (e.g.: "2-8 degrees C. Do not freeze," oras appropriate, etc.).

2.10 The product should remain stable up to the indicated testexpiry date if kept according to the required storagetemperature.

2.11 Standards (e.g.: "The vaccine should conform to standardsestablished by the Purchaser's country or, where no standardhas been adopted, meet current requirements published bythe WHO Expert Committee on Biological Standardization,or requirements of an established body of equivalent staturesuch as the US. Pharmacopoeia, the British Pharmacopoeia,the French Pharmacopoeia, or the InternationalPharmacopoeia").

3. Labeling 3.1 Each vial or ampoule shall carry the manufacturer's standardRequirements label in the language of Purchaser's country, if available at

no extra charge; otherwise, the label shall be in English.

3.2 Each vial or ampoule label shall state the following:

Section VIl. Sample Technical Specifications - Vaccines 117

(a) name of the vaccine;

(b) name of the manufacturer;

(c) place of manufacture;

(d) lot number;

(e) composition;

(f) concentration;

(g) dose mode for administration;

(h) expiration date;

(i) storage temperature;

() any other information that is appropriate.

3.3 All labeling shall withstand immersion in water and remainintact.

4. Packing 4.1 Inner boxes: Inner Boxes shall contain not more thanRequirements (number) individual vials/ampoules and shall be constructed

of sturdy white cardboard outfitted with individual segmentsfor protecting and separating each vial/ampoules.

4.2 Printed materials: Each inner box shall contain at least(number) manufacturer's standard package inserts in thelanguage of Purchaser's country if available at no extracharge; otherwise, package insert shall be in English.

4.3 Overpacking: Inner boxes shall be overpacked so that thevaccine remains refrigerated as designated in Clause 2.9. Theoverpacking must be suitable for export handling and be inaccordance with WHO Expanded Program of Immunization(EPI) Guidelines on International Packaging and Shipping ofVaccines including all measures needed to maintain requiredtemperatures for seventy-two (72) hours. It must haveadequate insulation and sufficient refrigerant to ensure thatthe warmest storage temperature of the vaccine does not riseabove that designated in Sub-Clause 2.9 when exposed tocontinuous outside temperature of +43 degrees C, nor fallbelow that specified of -20 degrees C during transit and for aperiod of at least twenty-four (24) hours after arrival at theairport destination. Additional cushioning shall be providedsufficient to protect the vials/ampoules from breakage duringtransit and handling.


4.4 Exterior shipping cartons: Product and printed materials,packaged as described above, shall be packed in weather-resistant, triple-wall corrugated fiberboard cartons with abursting test strength of not less than 1,900 kPa. The overalldimensions of the exterior shipping cartons should be suchthat the product does not become damaged duringtransportation and storage.

No shipping carton should contain vaccine from more thanone lot.

4.5 Cold chain monitor cards: Each insulated shipping containermust include appropriate temperature-monitoring devicesdesignated by the Purchaser.

(a) At least two suitable cold chain monitor cards, asapproved by the Purchaser, shall be packed in eachtransport case of vaccine.

(b) Freeze watch indicators shall be included in eachtransport case at the direction of Purchaser.

5. Marking 5.1 All containers and invoices must bear the followingRequirements information:

(a) the name of the vaccine;

(b) expiration date of the vaccine;

(c) appropriate storage temperature.

5.2 Inner boxes: The inner boxes containing vaccine vials orampoules shall be marked with the following information ina clearly legible manner that is acceptable to the Purchaser:

(a) Generic name and trade name of the vaccine;

(b) Manufacturer's name and trade registered address;

(c) Manufacturer's national registration number;

(d) Lot or batch number;

(e) Composition and concentration;

(f) Number of vials contained in box;

(g) Expiration date (month and year in clear language, notcode);

Section VII. Sample Technical Specifications - Vaccines 119

(h) Instructions for storage and handling;

(i) Place of manufacture (Made in

5.3 Exterior Shipping Cartons: The following information shallbe stenciled or labeled on the exterior shipping cartons ontwo opposing sides in bold letters at least 30mm high withwaterproof ink in a clearly legible manner that is acceptableto the Purchaser.

(a) Generic name and trade name of the vaccine;

(b) Lot or batch number;

(c) Expiration date (month and year in clear language, notcode);

(d) Manufacturer's name and registered address;

(e) Manufacturer's national registration number;

(f) Destination airport and routing;

(g) Consignee's name and address in full;

(h) Consignee contact name and telephone number;

(i) Number of vials or ampoules contained in the carton;

(j) Gross weight of each carton (in kg);

(k) Carton #_ of__

(1) Instructions for storage and handling;

(m) Contract number;

(n) Place of manufacture (Made in_ ).

6. Quality 6.1 All goods must:Control forSupply (a) meet the requirements of manufacturing legislation and

regulation of vaccines in the country of origin;

(b) meet internationally recognized standards for safety,efficacy, and quality;

(c) conform to all the specifications and related documentscontain herein;


(d) be fit for the purposes expressly made known to theSupplier by the Purchaser;

(e) be free from defects in workmanship and materials; and

(f) be certified by a competent authority in themanufacturer's country according to resolution WHA28-65(2), of the WHO release certificate.

6.2 The Supplier will be required to furnish to the Purchaser witheach consignment;

(a) A certificate of quality control and test results inconformity with the WHO release certificate.

(b) Assay methodology of any or all tests if required.

(c) Evidence of basis for expiration dating and otherstability data concerning the commercial final packageupon request.

6.3 Preshipment inspection and testing: The Supplier will berequired to provide the Purchaser or his representative withaccess to the product as packed for shipment at the sellers'factory and/or warehouse at a mutually agreeable time priorto shipment of the product.

(a) The Purchaser may inspect and sample, or cause to besampled, such product.

(b) The Purchaser may cause independent laboratorytesting to be performed as deemed necessary to ensurethat the Goods conform to prescribed requirements. Thetesting laboratory shall be of the Purchaser's choice andsuitably equipped and qualified to conduct qualitycontrol test on biological products.

121

Sample Technical Specifications

CONDOMS

1. Product and 1.1 The Goods must conform to the manufacturer's currentPackage standards for condoms and specified in line with the ISOSpecifications 4074 Standard for Latex Rubber Condoms.

1.2 The specifications for the Goods shall indicate criticalfactors, i.e., bursting volume and pressure, freedom fromholes, width and length, thickness, lubricant quality, andviscosity.

1.3 The Goods and packaging and labeling components shallmeet the standards specified in the latest WHO specification,including batch-by-batch independent quality controllaboratory tests.

1.4 Condoms should be shipped in special containers to ensurestability in transit from point of shipment to port/air port ofentry and point of destination for CIP deliveries. Any specialtemperature requirements must be designed to meet theclimatic conditions prevailing in the country of thePurchaser, and the Purchaser should advise the Supplier ofany particular requirements.

2. Labeling 2.1 The primary pack should be labeled in accordance with thelatest WHO specifications and include:

(a) Manufacturer's name;

(b) Batch number (printed at the time of packaging);

(c) Month and year of expiry; and

(d) Any other information as requested by the Purchaser.

2.2 The secondary packing, i.e., the inner box, should be labeledin accordance with the latest WHO specifications andinclude:

(a) Batch number;

(b) Month and year of manufacture (including the words:Date of Manufacture/month/year);

122 Section VII. Sample Technical Specifications - Condoms

(c) Manufacturer's name and registered address;

(d) Nominal width expressed in millimeters;

(e) Number of condoms in box;

(f) Instructions for storage; and

(g) Month and year of expiry.

3. Packaging 3.1 All exterior shipping cartons and packaging must complySpecification with the latest WHO specification for packaging of condoms.

4. Case 4.1 All cases should predominantly indicate the following:Identification

(a) Batch number;

(b) Month and year of manufacture (including the words:Date of Manufacture/month/year);

(c) Name and address of supplier;

(d) Nominal width expressed in millimeters;

(e) Number contained in the carton;

(f) Instructions for storage and handling; and

(g) Month and year of expiry.

5. Lot 5.1 All exterior shipping cartons for each batch should beTraceability assembled and shipped together to facilitate the monitoring

of batch quality during shipping and storage.

5.2 Both codes should be used on exterior shipping cartons, colorcoded for ease of identification if requested by the Purchaser.

6. Unique 6.1 The Purchaser will have the right to request the Supplier toIdentifiers imprint, provided the quantity justifies it, a logo on the

packaging of the condoms. The design and details will beclearly indicated at the time of bidding and shall be providedto the Supplier at the time of contract award.

7. Standards of 7.1 The Supplier will be required to provide the Purchaser withQuality access to its manufacturing facilities to inspect complianceControl for with the GMP requirements and quality control mechanisms.Supply

Section VII. Sample Technical Specifications - Condoms 123

8. Quality 8.1 (a) The Supplier shall be required to carry out testing of a

Control proposed shipment in line with the WHO specification,

Testing and the size of sample will be calculated by reference to

ISO 2859-1.

(b) With each consignment the Supplier must provide a

certificate of quality control test results in conformity

with the WHO specifications and in accordance with

the general sampling levels appropriate to each feature

as necessary.

125

SECTION VIII. SAMPLE FoRMs

126 Section VIII. Sample Forms

NOTES TO THE PURCHASER ON THE PREPARATION OF THE SAMPLE

FORMS

The Sample Forms provided in these SBD provide standard formats for anumber of the key documents that the Purchaser and Bidders will exchange in theprocess of bidding, awarding, and implementing the Contract. Most of the SampleForms are to be completed by the Purchaser. Except for the Bid Form and Form ofContract Agreement, the Purchaser or the Bidder may modify the forms to suit theparticular procurement. The forms are included in the Bidding Documents beforethey are released to potential Bidders. In turn, the Bidders or winning Bidder mustcomplete other forms, as indicated on the form, and submit them to the Purchaser.Notes providing instructions for the Purchaser, the Bidders, and the winning Bidderhave been provided. To avoid confusion, the Purchaser should remove all theinstructions to the Purchaser from the final version of the Bidding Documents that isreleased to potential Bidders.

The typographical aides used in the previous sections of the SBD continue inthis section. General explanatory text that appears in this text (sans serif typeface)remains intended for the Purchaser. General instructions or explanatory text aimedat Bidders and/or the winning Bidder appear in standard roman typeface.Instructions that appear directly in the forms continue to be in italicized romantypeface, set off with square brackets and intended for the Bidders or the winningBidder. If an instruction is meant for the Purchaser, it is identified as such.Purchasers are encouraged to provide as many of these Sample Forms as possiblein revisable, electronic format in the Bidding Documents. This will expedite bidpreparation, reduce the number of inadvertent mistakes made by Bidders, and, as aresult, simplify the evaluation.

Bid Form and Forrm of Contract Agreement: Except as indicated by blanksand/or instructions to fill in information, the text of the Bid Form and the ContractAgreement should be left unaltered in the Bidding Documents from how it appearsin these SBD. It would be at the time of Contract award when the Purchaser has anopportunity to add the final details needed in the Contract Agreement form, bymaking any necessary insertions or changes to paragraph 2.

Since the Price Schedules will form part of the final Contract, if there havebeen any corrections or modifications to the winning bid resulting from pricecorrections, pursuant to the Instructions to Bidders, these too should be reflected inthe Price Schedules at the time of Contract award.

Price Schedules: The price breakdown given in the sample Price Schedulesgenerally follows the usual breakdown requested for procurement of Goods in orderfor the domestic preference procedure to be applied. It is essential that Bidders

Section VIII. Sample Forms 127

submit their prices in the manner prescribed by the Price Schedules. Failure to doso, may result in loss of the preference, if applicable.

Manufacturer's Authorization Form: In accordance with ITB Sub-Clause 7.1 (b), Bidders must submit, as part of their bids, Manufacturer'sAuthorization Form(s) in the format provided in the SBD for all items specified in theBid Data Sheet.

Bid Security Form: Regarding ITB Clause 19, the Purchaser should includethe Bid Security form provided in the SBD in the Bidding Documents. ThePurchaser must ensure that the new form substantially complies with the features ofthe form included here in respect to its degree of protection and clarity of conditionsunder which it can be made effective.

Performance Security Form: Pursuant to GCC Sub-Clause 8.1, thesuccessful Bidder is required to provide the performance security within twenty-eight(28) days of notification of Contract award.

Advance Payment Bank Guarantee: Pursuant to GCC Sub-Clause 16.1, thesuccessful Bidder is required to provide a bank guarantee securing the advancepayment, if SCC related to GCC Sub-Clause 16.1 provides for one.


NOTES TO BIDDERS ON THE PREPARATION OF SAMPLE FORMS

The Purchaser has prepared the forms in this section of the Bidding Documents to suitthe specific requirements of the procurement. In its bid, the Bidder MUST use these forms(or forms that present in the same sequence substantially the same information). If the Bidderhas a question regarding the meaning or appropriateness of the contents or format of theforms and/or the instructions contained in them, these questions should be brought to thePurchaser's attention as soon as possible during the bid clarification process, by addressingthem to the Purchaser in writing pursuant to ITB Clause 11.

The Purchaser has provided explanatory text and instructions to help the Bidderprepare the forms accurately and completely. The instructions that appear directly on theforms themselves are indicated by use of typographical aides such as italicized text withinsquare brackets.

In preparing its bid, the Bidder MUST ensure all such information is provided andthat the typographical aides are removed.


SAMPLE FORMS

1. Bid Forn .130

2. Price Schedule for Goods Offered from Abroad .132

3. Price Schedule for Domestic Goods Offered from within thePurchaser's Country .133

4. Bid Security For .134

5. Form of Contract Agreement .136

6. Performance Security Bank Guarantee .138

7. Bank Guarantee Form for Advance Payment .140

8. Manufacturer's Authorization Form .142

9. Specimen Certificate of a Pharmaceutical Product .143

130 Section VIII. Sample Forns

1. Bid Form

Date: [ insert: date of bid]

Loan/Credit No.: [Purchaser insert: number]

[Purchaser specify: "IFB No.: [number]"]

[ insert: name of Contract]

To: [Purchaser insert: Name and address ofPurchaser ]

Dear Sir or Madam:

Having examined the Bidding Documents, including Addenda Nos. [insertnumbers J, the receipt of which is hereby acknowledged, we, the undersigned, offer to supplyand deliver the Goods under the above-named Contract in full conformity with the saidBidding Documents for the sum of:

[ insert: amount of local currency ([ insert: amount of local currencyin words] in figures])

plus [ insert: amount offoreign ([insert: amount offoreigncurrency A in words] currencyA infigures])

[as appropriate, include the following]

plus [ insert: amount offoreign ([insert: amount offoreigncurrency B in words] currency B infigures])

plus [ insert: amount offoreign ([ insert: amount offoreigncurrency C in words] currency C infigures])

(hereinafter called "the Total Bid Price") or such other sums as may be determined inaccordance with the terms and conditions of the Contract. The above amounts are inaccordance with the Price Schedules attached herewith and are made part of this bid.

We undertake, if our bid is accepted, to deliver the Goods in accordance with thedelivery schedule specified in the Schedule of Requirements.

Section VIII. Sample Forns 131

If our bid is accepted, we undertake to provide an advance payment security and aperformance security in the form, in the amounts, and within the times specified in theBidding Documents.

We agree to abide by this bid, for the Bid Validity Period specified in Clause 18.1 ofthe Bid Data Sheet and it shall remain binding upon us and may be accepted by you at anytime before the expiration of that period.

Until the formnal final Contract is prepared and executed between us, this bid, togetherwith your written acceptance of the bid and your notification of award, shall constitute abinding Contract between us. We understand that you are not bound to accept the lowest orany bid you may receive.

Commissions or gratuities, if any, paid or to be paid by us to agents relating to thisbid, and to contract execution if we are awarded the Contract, are listed below:

Narne and Address Amount and Purpose ofof Agent Currency Commission or

_ ratuity

(if none, state "none")

Dated this [ insert: number] day of [ insert: month], [insert: year].

Signed:

Date:

In the capacity of [ insert: title or position I

Duly authorized to sign this bid for and on behalf of insert: name of Bidder]

2. Price Schedule for Goods Offered from Abroad

(Group C bids)

Name of Bidder ____________IFB Number ____Page. of_._

1 2 3 4 5 6 7 8 9 10 I11 12 13 14

Product Product Strength Dosage Unit Qty. Unit prices Total Total Local Shipment Name of Ctry. Pharma-

code form pack offered unit price per agent's weight manufac- of copoeial

size [a] [b] [C] [d] price item commission and turer origin standardUnit CfF at inland Other [a+c+d) [6 x 8] as a % of volumeprice port of trasp., incidental or FOB priceFOB entry or insurance costs as [b+c+d] included inport CIP & other defined inuoe

loading namned local costs the SCC qoeplace of incidental pricedestina- to

tion delivery if(specify specified

one)~~~~~~~~~~~~Note. Total Bid Price:(i) Column 7[c] is optional and it will be applicable only when required in accordance with ITB CUrrency:

Sub-Clause 16.2 (b) (iv) and (v) and the related provisions in the Bid Data Sheet.(ii) For column 9, pursuant toITB 30.1,in the case of discrepancy between unit price and total In figures:

price, the unit price shall prevail. In words: CD

0

0D

NameofBidder . IFBNumber . Page of_.~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~(

2 3 4 s 6 8 9 -i-o 12 13 14~~~~~~~~~~~~~~~~~~~

CD0

3. Price Schedule for Domestic Goods Offered from within the Purchaser's Country

(Group A and Group B bids)

Name of Bidder . IFB Number Page of0

1 2 3 4 5 6 7 8 9 10 I11 12 13

Product Product Strength Dosage Unit Qty. Unit prices Total Total Sales and Name of Pharma- Local input incode form pack offered unit price other manufacturer copocial the cost as %

size [a] lb] [c] price per item taxes standard of ex-factoryEx-factory Inland transp., Other incident- [a+b+c] [6 x 8] payable if price in

Ex-warehouse insurance & al costs as contract is column 7[a]Ex-showroom other local costs defined in the awardedOff the shelf incidentalto SCC

_______ _______ delivery _ _ _ _ _ _ _ _ _ _ _ _

Note: Total Bid Price:(i) Column 7[b] is optional and it will be applicable only when required in accordance with lTB Sub-Clause 16.2 Currency:

(a) (iii) and (iv) and the related provisions in the Bid Data Sheet.(ii) For column 9, pursuant to ITB 30.1 in the case of discrepancy between unit price and total price, the unit price In figures:

shall prevail. In words:(iii) For column 13, a breakdown of the cost of local labor, local raw materials, and local components provided

from within the country should also be indicated separately as specified in ITB Sub-Clause 27.1 along withadequate proof to substantiate each of these local inputs.


4. Bid Security Form

Date: [insert: date ]Loan/Credit Number: [insert: loan or credit number from IFBR

IFB: [insert: name and number of IFB ]Contract: [insert: name and number of Contract]

To: [insert: name and address of Purchaser j

WHEREAS [insert: name of Bidder] (hereinafter called "the Bidder") has submitted itsbid dated [insert: date of bid] for the performance of the above-named Contract(hereinafter called "the Bid")

KNOW ALL PERSONS by these present that WE [insert: name of bank] of [insert:address of bank] (hereinafter called "the Bank") are bound unto [insert: name ofPurchaser ] (hereinafter called "the Purchaser") in the sum of: [insert: amount ], for whichpayment well and truly to be made to the said Purchaser, the Bank binds itself, its successorsand assigns by these presents.

Sealed with the Common Seal of the said Bank this [insert: number] day of [insert:month , [insert: year].

THE CONDITIONS of this obligation are the following:

1. If, after the bid submission deadline, the Bidder

(a) withdraws its bid during the period of bid validity specified by the Bidder in theBid Form, or

(b) does not accept the Purchaser's corrections of arithmetic errors in accordance withthe Instructions to Bidders; or

2. If the Bidder, having been notified of the acceptance of its bid by the Purchaser duringthe period of bid validity

(a) fails or refuses to sign the Contract Agreement when required; or

(b) fails or refuses to issue the performance security in accordance with theInstructions to Bidders.

We undertake to pay to the Purchaser up to the above amount upon receipt of its first writtendemand, without the Purchaser having to substantiate its demand, provided that in its demandthe Purchaser will note that the amount claimed by it is due it, owing to the occurrence of anyone of the two above-named CONDITIONS, and specifying the occurred condition orconditions.


This guarantee will remain in full force up to and including [ insert: the date that is 30 daysafter the period of bid validity], and any demand in respect thereof must reach the Bank notlater than the above date.

For and on behalf of the Bank

Signed:Date:in the capacity of: [ insert: title or other appropriate designation]

Common Seal of the Bank


5. Form of Contract Agreement

THIS CONTRACT AGREEMENT is made

the [ insert: number] day of [ insert: month], [insert: year].

BETWEEN

(1) [insert: Name of Purchaser], a [ insert: description of type of legal entity,for example, an agency of the Ministry of.... of the Government of [ insert:country of Purchaser], or corporation incorporated under the laws of[insert: country of Purchaser]] and having its principal place of businessat [ insert: address of Purchaser] (hereinafter called "the Purchaser"), and

(2) [insert: name of Supplier ], a corporation incorporated under the laws of[insert: country of Supplier] and having its principal place of business at[insert: address of Supplier ] (hereinafter called "the Supplier").

WHEREAS the Purchaser invited bids for certain goods and ancillary services, viz., [insert:brief description of goods and services] and has accepted a bid by the Supplier for thesupply of those goods and services in the sum of [ insert: contract price in words andfigures ] (hereinafter called "the Contract Price").

NOW THIS AGREEMENT WITNESSETH AS FOLLOWS:

1. In this Agreement words and expressions shall have the same meanings as arerespectively assigned to them in the Conditions of Contract referred to.

2. The following documents shall constitute the Contract between the Purchaser and theSupplier, and each shall be read and construed as an integral part of the Contract:

(a) This Contract Agreement

(b) Special Conditions of Contract

(c) General Conditions of Contract

(d) Technical Requirements (including Functional Requirements andImplementation Schedule)

(e) The Supplier's bid and original Price Schedules

(f) The Purchaser's Notification of Award


(g) The Purchaser's Notification of Award

(h) [Add here: any other documents]

3. In consideration of the payments to be made by the Purchaser to the Supplier ashereinafter mentioned, the Supplier hereby covenants with the Purchaser to provide theGoods and Services and to remedy defects therein in conformity in all respects with theprovisions of the Contract.

4. The Purchaser hereby covenants to pay the Supplier in consideration of the provision ofthe Goods and Services and the remedying of defects therein, the Contract Price or suchother sum as may become payable under the provisions of the Contract at the times andin the manner prescribed by the Contract.

For and on behalf of the Purchaser

Signed:in the capacity of [ insert: title or other appropriate designation]

in the presence of

For and on behalf of the Supplier

Signed:in the capacity of [ insert: title or other appropriate designation]

in the presence of

CONTRACT AGREEMENTdated the [insert: number j day of [ insert: month], [insert. year ]

BETWEEN

[insert: name of Purchaser ], "the Purchaser"

and

[insert: name of Supplier], "the Supplier"


6. Performance Security Bank Guarantee

(unconditional)

Date: [insert: date]

Loan/Credit Number: [insert: loan or credit number from IFB ]

IFB: [insert: name or number of IFB ]

Contract: [insert: nameornumberofContract]

To: [insert: name and address of Purchaser]

Dear Sir or Madam:

We refer to the Contract Agreement ("the Contract") signed on [insert: date]between you and [insert: name of Supplier] ("the Supplier") concerning the supply anddelivery of [insert: a brief description of the Goods]. By this letter we, the undersigned,[insert: name of bank], a bank (or company) organized under the laws of [ insert: countryof bank] and having its registered/principal office at [ insert: address of bank ],(hereinafter, "the Bank") do hereby jointly and severally with the Supplier irrevocablyguarantee payment owed to you by the Supplier, pursuant to the Contract, up to the sum of[insert: amount in numbers and words]. This guarantee shall be reduced or expire asprovided for by GCC Sub-Clause 8.4.

We undertake to make payment under this Letter of Guarantee upon receipt by us ofyour first written demand signed by your duly authorized officer declaring the Supplier to bein default under the Contract and without cavil or argument any sum or sums within theabove-named limits, without your need to prove or show grounds or reasons for your demandand without the right of the Supplier to dispute or question such demand. Our liability underthis Letter of Guarantee shall be to pay to you whichever is the lesser of the sum so requestedor the amount then guaranteed under this Letter in respect of any demand duly made underthis Letter prior to expiry of this Letter of Guarantee, without being entitled to inquirewhether or not this payment is lawfully demanded.

This Letter of Guarantee shall be valid from the date of issue until the date ofexpiration of the guarantee, as governed by the Contract. Except for the documents hereinspecified, no other documents or other action shall be required, notwithstanding anyapplicable law or regulation. Our liability under this Letter of Guarantee shall become null

Section VIII. Sample Fonns 139

and void immediately upon its expiry, whether it is returned or not, and no claim may bemade under this Letter after such expiry or after the aggregate of the sums paid by us to youshall equal the sums guaranteed under this Letter, whichever is the earlier. All notices to begiven under this Letter shall be given by registered (airmail) post to the addressee at theaddress herein set out or as otherwise advised by and between the parties hereto.

We hereby agree that any part of the Contract may be amended, renewed, extended,modified, compromised, released, or discharged by mutual agreement between you and theSupplier, and this security may be exchanged or surrendered without in any way impairing oraffecting our liabilities hereunder without notice to us and without the necessity for anyadditional endorsement, consent, or guarantee by us, provided, however, that the sumguaranteed shall not be increased or decreased.

No action, event, or condition that by any applicable law should operate to dischargeus from liability hereunder shall have any effect, and we hereby waive any right we may haveto apply such law, so that in all respects our liability hereunder shall be irrevocable and,except as stated herein, unconditional in all respects.


Signed:

Date:

in the capacity of: [ insert: title or other appropriate designation]



7. Bank Guarantee Form for Advance Payment

Date: [ insert: date]

Loan/Credit Number: [ insert: loan or credit numberfrom IFB]

IFB: [insert: name and number of IFB J

Contract: [insert: nameandnumberofContract]

To: [insert: name and address of Purchaser]

Dear Sir or Madam:

We refer to the Contract Agreement ("the Contract") signed on [insert: date] between you

and [insert: name of Supplier ] ("the Supplier") concerning supply and delivery of [ insert:

a brief description of the goods].

Whereas, in accordance with the terms of the said Contract, the Purchaser has agreed to pay

or cause to be paid to the Supplier an Advance Payment in the amount of [ insert: amount in

numbers and words, for each currency of the Advance Payment] due to the Supplier.

By this letter we, the undersigned, [insert: name of bank], a bank (or company) organized

under the laws of [insert: country of bank] and having its registered/principal office at

[insert: address of bank ], (hereinafter, "the Bank") do hereby jointly and severally with the

Supplier irrevocably guarantee repayment of the said amounts upon the first demand of the

Purchaser without cavil or argument in the event that the Supplier fails to commence or fulfill

its obligations under the terms of the said Contract, and in the event of such failure, refuses to

repay all or part (as the case may be) of the said Advance Payment to the Purchaser.Provided always that the Bank's obligation shall be limited to an amount equal to the

outstanding balance of the Advance Payment, taking into account such amounts that havebeen repaid by the Supplier from time to time in accordance with the terms of payment of the

said Contract as evidenced by appropriate shipping documents or payment certificates.

This Guarantee shall remain in full force from the date upon which the said Advance

Payment is received by the Supplier until the date upon which the Supplier has fully repaidthe amount so advanced to the Purchaser in accordance with the terms of the Contract. At the

time at which the outstanding amount is nil, this Guarantee shall become null and void,


whether the original is returned to us or not. Any claims to be made under this Guaranteemust be received by the Bank during its period of validity.


Signed:

Date:

in the capacity of: [ insert: title or other appropriate designation ]



8. Manufacturer's Authorization Form

(Manufacturer's or Producer's letterhead)

To: [insert: nameofthePurchaser]

WHEREAS [insert: name of the manufacturer or producer] (hereinafter, "we" or "us"l)who are established and reputable manufacturers or producers of [insert: name and/ordescription of the Goods requiring this authorization] (hereinafter, "Goods") havingproduction facilities at [ insert. address offactory ] do hereby authorize [ insert: name andaddress of Bidder] (hereinafter, the "Bidder") to submit a bid, and subsequently negotiateand sign the Contract with you against IFB [insert: title and reference number of theInvitation for Bids ] including the above Goods produced by us.

We hereby extend our full guarantee and warranty for the above specified Goods againstthese Bidding Documents.

For and on behalf of the Manufacturer or Producer

Signed:

Date:

In the capacity of [ insert: title, position, or other appropriate designation ] and dulyauthorize to sign this Authorization on behalf of [ insert: name of manufacturer orproducer]


9. Specimen Certificate of a Pharmaceutical Product

Certificate of a Pharmaceutical Product'

This certificate conforms to the format recommended by the World Health Organization(general instructions and explanatory notes attached).

No. of certificate:

Exporting (certifying) country:

Importing (requesting) country:_

1 . Name and dosage form of product:

1.1 Active ingredients2 and amount(s) per unit dose.3

For complete qualitative composition including excipients, see attached.4

1.2 Is this product licensed to be placed on the market for use in the exportingcountry?5 yes/no (key in as appropriate)

1.3 Is this product actually on the market in the exporting country?yes/no/unknown (key in as appropriate)

If the answer to 1.2 is yes, continue with section 2A and omit section 2B.

If the answer to 1.2 is no, omit section 2A and continue with section 2B.6

2A. 1 Number of product license' and date of issue:

2A.2 Product-license holder (name and address):


2A.3 Status of product-license holder:8 a/b/c (key in appropriate category asdefined in note 8)

2A.3.1 For categories b and c the name and address of the manufacturer producing thedosage form are:

2A.4 Is Summary Basis of Approval appended?'" yes/no (key in as appropriate)

2A.5 Is the attached, officially approved product information complete andconsonant with the license?'" yes/no/not provided (key in as appropriate)

2A.6 Applicant for certificate, if different from license holder (name and address):'2

2B. 1 Applicant for certificate (name and address):

2B.2 Status of applicant: a/b/c (key in appropriate category as defined in note 8)

2B.2.1 For categories b and c the name and address of the manufacturer producing thedosage form are:9

2B.3 Why is marketing authorization lacking?

not required/not requested/under consideration/refused (key in as appropriate)

2B.4 Remarks:'3

3. Does the certifying authority arrange for periodic inspection of the manufacturing plantin which the dosage form is produced?

yes/no/not applicable'4 (key in as appropriate)

If no or not applicable proceed to question 4.

3.1 Periodicity of routine inspections (years):

3.2 Has the manufacture of this type of dosage form been inspected?

yes/no (key in as appropriate)


3.3 Do the facilities and operations conform to GMP as recommended by the WorldHealth Organization?'5

yes/no/not applicable16 (key in as appropriate)

4. Does the information submitted by the applicant satisfy the certifying authority on allaspects of the manufacture of the product?'1


If no, explain:

Address of certifying authority:

Telephone number: Fax number:

Name of authorized person:

Signature:

Stamp and date:

General instructionsPlease refer to the guidelines for full instructions on how to complete this form andinformation on the implementation of the Scheme.

The forms are suitable for generation by computer. They should always be submitted as hardcopy, with responses printed in type rather than handwritten.

Additional sheets should be appended, as necessary, to accommodate remarks andexplanations.

Explanatory notes

This certificate, which is in the format recommended by WHO, establishes the status of the pharmaceuticalproduct and of the applicant for the certificate in the exporting country. It is for a single product only sincemanufacturing arrangements and approved information for different dosage forms and different strengthscan vary.

2 Use, whenever possible, international nonproprietary names (INNs) or national nonproprietary names.3 The formula (complete composition) of the dosage form should be given on the certificate or be appended.


4 Details of quantitative composition are preferred, but their provision is subject to the agreement of the

product-license holder.When applicable, append details of any restriction applied to the sale, distribution, or administration of theproduct that is specified in the product license.

6 Sections 2A and 2B are mutually exclusive.7 Indicate, when applicable, if the license is provisional or if the product has not yet been approved.

Specify whether the person responsible for placing the product on the market:(a) manufactures the dosage form;(b) packages and/or labels a dosage form manufactured by an independent company; or

(c) is involved in none of the above.9 This information can be provided only with the consent of the product-license holder or, in the case of non-

registered products, the applicant. Noncompletion of this section indicates that the party concerned has not

agreed to inclusion of this information. It should be noted that information concerning the site of

production is part of the product license. If the production site is changed, the license must be updated or itwill cease to be valid.

'° This refers to the document, prepared by some national regulatory authorities, that summarizes the

technical basis on which the product has been licensed.This refers to product information approved by the competent national regulatory authority, such as a

Summary of Product Characteristics (SPC).12 In this circumstance, permission for issuing the certificate is required from the product-license holder. This

permission must be provided to the authority by the applicant.'3 Please indicate the reason that the applicant has provided for not requesting registration:

(a) The product has been developed exclusively for the treatment of conditions-particularly tropicaldiseases-not endemic in the country of export.

(b) The product has been reformulated with a view to improving its stability under tropical conditions.(c) The product has been reformulated to exclude excipients not approved for use in pharmaceutical

products in the country of import.(d) The product has been reformulated to meet a different maximum dosage limit for an active

ingredient.(e) Any other reason, please specify.

4 Not applicable means that the manufacture is taking place in a country other than that issuing the product

certificate and inspection is conducted under the aegis of the country of manufacture.is The requirements for good practices in the manufacture and quality control of drugs referred to in the

certificate are those included in the thirty-second report of the Expert Committee on Specifications forPharmaceutical Preparations (WHO Technical Report Series, No. 823, 1992, Annex 1). Recommendationsspecifically applicable to biological products have been formulated by the WHO Expert Committee onBiological Standardization (WHO Technical Report Series, No. 822, 1992, Annex 1).

16 This section is to be completed when the product-license holder or applicant conforms to status (b) or (c) asdescribed in note 7 above. It is of particular importance when foreign contractors are involved in themanufacture of the product. In these circumstances the applicant should supply the certifying authority

with information to identify the contracting parties responsible for each stage of manufacture of thefinished dosage form, and the extent and nature of any controls exercised over each of these parties.

The layout for this Model Certificate is available on diskette in WordPerfect from the Division of DrugManagement and Policies, World Health Organization, 1211 Geneva 27, Switzerland.

TECHNICAL NOTE

Procurement of HealthSector Goods

The World Bank

May 2000

iii

Contents

1. Introduction ............................................................ 1

2. Health Sector Product Descriptions ............................................................. 3

3. Project Design Considerations ............................................................ 4

3.1 Introduction .. 4

3.2 Assessments .. 73.2.1 Country Level .73.2.2 Procurement Capacity of Implementing Agency .8

3.3 National Policies .. 10

3.4 Local Production .. 12

3.5 Centralized versus Decentralized Procurement .. 133.5.3 Centralized Procurement .133.5.4 Decentralized Procurement .143.5.5 Selective Decentralization of Procurement Responsibilities .15

3.6 Prequalification versus Postqualification .. 15

3.7 Product Quality Assurance .. 17

3.8 Marketing Authorization (Product Registration) ....................................... 19

3.9 Importation Issues ........................................................... 203.10 Logistics ........................................................... 21

3.11 Procurement Methods ........................................................... 233.11.2 International Competitive Bidding ............................................................ 233.11.3 National Competitive Bidding ........................................................... 243.11.4 Limited International Bidding ........................................................... 253.11.5 International or National Shopping .................................... ....................... 253.11.6 Direct Contracting ........................................................... 253.11.7 Procurement from United Nations Sources or Other Agencies .............................. 263.11.8 Use of Procurement Assistance or Agency Services from UN or

Other Agencies ........................................................... 26

3.13 Guidelines for Selecting a Procurement Method for Each Product Group . . 28

4. Procurement Planning Considerations ..................................... 31

4.1 Selection of Health Sector Goods to Be Financed .. 314.1.1 Pharmaceuticals .314.1.2 Vaccines .324.1.3 Contraceptives .324.1.4 Nutritional Supplements .334.1.5 Medical Equipment .33

4.2 Quantification of Requirements .. 344.2.2 Pharmaceuticals .344.2.3 Vaccines .354.2.4 Contraceptives .354.2.5 Nutritional Supplements .364.2.6 Medical Equipment .36

iv Technical Note for the Procurement of Health Sector Goods

4.3 Technical Specifications ........................................................... 364.3.2 Pharmaceuticals, Vaccines, Contraceptives, and Nutritional Supplements ........... 374.3.3 Medical Equipment ........................................................... 38

4.4 Procurement Packaging and Scheduling ........................................................... 39

4.5 Drug Kits ............................................................ 394.6 Scheduling ....... 40

Annex 1. Detailed Product Descriptions . . .41

1.1 Pharmaceuticals ................ 41

1.2 Vaccines ................ 42

1.3 Contraceptives ................ 43

1.4 Nutritional Supplements ................ 44

1.5 Medical Equipment ................ 44

Annex 2: Guidelines for Prequalification .45

Annex 3. Miscellaneous Considerations .53

1.1 Stability and Shelf Life ................................. 53

1.2 Samples ................................. 541.3 Special Storage and Transportation Conditions ................................. 54

1.4 Product and Product Packaging Specifications ................................. 551.5 Labeling ................................. 571.6 Inspection and Testing ................................. 58

Annex 4. Model Certificate of a Pharmaceutical Product . .59

Abbreviations .63

Glossary.64

Reference List .65

Useful Contact Information .67

Technical Note for the Procurement of Health Sector Goods I

1. Introduction 1.1 World Bank financing for procurement of pharmaceuticals, vaccines,contraceptives, and nutritional supplements under various health,population, and nutrition projects (called collectively "health sectorgoods" in this Technical Note [TN]) has increased significantly over thepast few years, and the trend is expected to continue. Assistance underthese projects supports the procurement of, for example, contraceptivesfor family planning programs, pharmaceuticals, vaccines, and other healthsector goods for AIDS, tuberculosis, leprosy, malaria, and maternal andchild health (MCH) programs. The Bank programmed $1.8 billion for theperiod 1997/98 for the Health, Nutrition, and Population (HNP) sector.Financing for pharmaceuticals forms about $220 million to $250 millionof this total. Annual HNP sector lending for medical equipment has beenestimated at $200 million to $400 million'

1.2 This TN accompanies the Standard Bidding Documents (SBDs) forhealth sector goods. Both documents have been updated following theintroduction of the SBDs on a trial basis in 1993, review by Bank staffand interested parties (donors, UN agencies, and industry) andsubsequent revision. The SBDs for health sector goods wereintroduced to facilitate uniformity of approach in the procurement ofthese items and because health sector goods, especiallypharmaceuticals, vaccines, and contraceptives, differ significantlyfrom the type of goods typically procured in infrastructure, energy,industry, and agricultural projects based on which the Bank's SBDsfor the Procurement of Goods were originally developed' Forexample, pharmaceuticals, vaccines, and contraceptives differ fromother goods in terms of diversity, the terminology used to express theirspecific chemical and generic characteristics, stability criteria, shelf-life limitations, special storage requirements, susceptibility to heat andlight, quick obsolescence, and rigid quality control requirements.Significant price differences can exist between brand name andgeneric products. The procurement of medical equipment raisesadditional issues. The use of technology for the diagnosis, treatment,and rehabilitation of people is developing very rapidly. Among otherfactors, increased computerization of equipment makes addressingsubjects as quality and safety standards, total costs of ownership (forexample: maintenance or software upgrades) and training, a challenge.Therefore, the tasks of preparing broad specifications that willencourage competition and carrying out fair and transparentevaluations have become increasingly more difficult. Issues regardingintellectual property rights must also be addressed.

Medical Equipment Procurement Study, Development Finance International, Inc./ECRI, March 1998.2 The Medical Equipment Procurement Study authors concluded that the SBDs for Goods are appropriate for

the procurement of medical equipment. The broad principals outlined in this technical note, however, arealso applicable to the purchase of medical equipment. Customization of the SBDs for Goods to address anyparticular technical or legal requirement related to the purchase of medical equipment must be donethrough the Bid Data Sheet, the Special Conditions of Contract, and the Technical Specifications.

2 Technical Note for the Procurement of Health Sector Goods

1.3 In addition, the nature of the marketplace for health sector goods, andparticularly for drugs, suffers from a number of market failures. Anumber of reasons account for this situation. The consumer does notchoose the drug (vaccine or contraceptive formulation)-usually adoctor or pharmacist makes this decision-and is not trained to judgethe appropriateness, safety, quality, and value for money. The averagemedical practitioner or pharmacist does not have the expertise toindependently assess the quality, safety, or efficacy of each new drugon the market. Substandard counterfeit drugs are very difficult todetect and yet have the potential to cause considerable harm. Thegovernment therefore has a responsibility during the acquisition ofhealth sector goods to be well informed about available products, tokeep up to date with developments, and to take appropriate steps toensure that only quality products enter the public health system.

1.4 Pharmaceuticals, vaccines, contraceptives, nutritional supplements,and medical equipment are essential to the improvement of apopulation's health and well-being. The government's responsibilitiesare wide ranging. Included are the oversight of the range of productsto be available in both the public and private sectors; the establishmentof standards for, and monitoring of, the quality of health sector goodsmanufactured in the country or imported; the efficient distribution ofthese products through public health facilities in countries where itsrole is as the predominant provider of health care; and ensuring thatappropriate diagnosis, prescribing, dispensing, and use by consumerstake place. Additionally, as a provider of health care, the governmentis likely to be involved in the procurement of health sector goods,whether financed through central funds, loans, or donation.

1.5 The purpose of this TN is to provide background information to Bankproject staff and borrowers, about the complex problems and issues inthis kind of procurement, and to help them make well-informeddecisions in each special situation2. Recommendations on whichprocurement method is likely to be most suited to each situation andtype of health sector good are presented. The Bank's StandardBidding Documents for Procurement of health sector goods is requiredto be used, where appropriate, by borrowers for procurementconducted through international competitive bidding (ICB). Anumber of clauses and instructions-such as those on TechnicalSpecifications and required supporting documentation fromsuppliers-are also relevant to other procurement methods to ensureappropriate quality goods are purchased. Special clauses have also

Additional guidance and sources of information can be found on the Bank's Internet- and intranet system,including the Help Desk network HNP advisory service. The following are useful sites:[email protected] and [email protected]. Also, advice on consultants to help with projectdesign and procurement planning can be sought from HDNHE (contact the help desk at previous Internetaddress or call [202] 473-2256). Assistance can be obtained by reviewing phannaceutical technicalspecifications from WHO - Essential Drugs and Other Medicines Unit at WHO, CH-121 1 Geneva 27,Switzerland.

Technical Note for the Procurement of Health Sector Goods 3

been provided for particular health sector goods to address uniquefeatures or issues they may present. Project staff assisting borrowersinterested in using the SBDs should first carefully study this TN. TheTN is not intended to be a substitute for the involvement of aprocurement expert in advising task team leaders (TTLs) onprocurement matters.

1.6 Bank procurement policies and processes are often perceived to be thecause of slow progress in project implementation. A soundapplication of these practices, however, would ensure that Bank-financed procurement meets standards of efficiency, economy, andtransparency. It is important to note that borrowers' own constraintsare also a major factor in determining the pace of implementation.The provisions of national policies, the completeness of regulationsand guidelines, institutional arrangements, and the level ofmanagement capacity within the borrowing country's health systemare equal if not greater contributing factors to prompt and efficientimplementation. This TN will describe several issues, conditions, andactivities that if properly addressed during project design andappraisal, and in advance of the procurement process, will greatlyfacilitate the proper and expeditious purchase of appropriate qualityhealth sector goods. These circumstances are described in the sectionProject Design Considerations (page 4).

2. Health Sector 2.1 Categories of health sector goods. The following is a description ofProduct the various categories of health sector goods that are normallyDescriptions included in Bank-financed health projects. For a more detailed

description, see annex 1.

Pharnaceuticals The most common pharmaceuticals used to treat about ninetypercent (90%) of all the causes of morbidity in developingcountries are included on the WHO model list of essential drugs,and are often available in generic forrn. Other pharmaceuticalproducts with specialized uses may also be included in nationalessential drug lists. These include the following: proprietarypharmaceuticals (newer pharmaceutical products manufacturedunder patent and often used at the tertiary level of health care);drugs for tropical diseases (used infrequently in most exportingcountries but extensively in tropical countries to control majorepidemic diseases); pharmaceuticals used for certain rare diseasesthat therefore have a very limited market; and pharmaceuticals, theconsumption of which is small and sporadic in a developingcountry, primarily because of cost.

Biological These biological products include vaccines for universal (child)Products immunization and products that immunize specific risk groups

against specific diseases. Many of these are named in essentialdrug lists.


Contraceptives Contraceptives take a number of different forms, includingpharmaceutical products. Mechanical contraceptives, e.g.,condoms and intrauterine devices (IUDs), may be classified asdrugs or medical devices and need also to be regulated by the localregulatory agency for quality control. The WHO essential drug listincludes hormonal contraceptives, both pill and injection forn,copper-bearing intrauterine devices, and condom and diaphragmbarrier methods.

Nutritional Nutritionals are pharmaceutical products, including amino acidsAdditives and combinations, minerals and electrolytes, miscellaneous

nutritional supplements, vitamins and combinations, prenatal,renal, and therapeutic formulations. WHO includes a number ofsuch products in the model list of essential drugs.

Medical The Bank primarily supports the financing of capital-mechanical,Equipment electronic, diagnostic, and life-support products-as opposed to

consumable medical equipment. The range of available equipmentis extensive, but guidelines on the type of standard equipment thatshould be on site at primary, secondary, and tertiary facilities havebeen drafted on behalf of the Bank. TTLs may refer to these"Standard Equipment Lists" as the basis for discussion withborrowers on the acceptability of medical equipment for financingwith Bank loans.

3. Project Design 3.1 IntroductionConsiderations

3.1.1 The World Bank finances projects in the health sector as part ofits focus on assisting development in countries throughinvestment in people and strengthening the ability ofgovernments to deliver quality services efficiently andtransparently. Projects may support reviews of the overallhealth sector organization, the development and financing ofplans for decentralization, training, infrastructure, the provisionof technical assistance to country ministries of health, etc., aswell as the procurement of goods, works, and services,including pharmaceuticals, vaccines, contraceptives, nutritionalsupplements, and medical equipment. The outcome of a projectwill be significantly enhanced by timely and cost-effectiveprocurement. This can be achieved through careful packagingand the competent implementation of procurement procedures(which comply with Bank regulations) combined with attentionto a number of areas that influence the environment forprocurement activities in the borrower country. The teamdesigning and carrying out the project must be adequatelystaffed and fully conversant with these procurement proceduresto ensure successful implementation.

3.1.2 Precisely defined, procurement can be presented as one step inthe process of ensuring that good quality cost-effective


commodities are available to support health sector services, asin figure 1.4 Procurement follows on from selection-theinformed determination of the most suitable items to obtain forthe health system-and precedes the distribution (or allocation,in the case of medical equipment) of the products to thedispensing unit and subsequent rational use by the consumer.Underlying the whole process is the national legislative andregulatory framework.

Figure I

3.1.3 World Bank project experience has been that the objectives ofprocurement are successfully met only when careful attention ispaid to a much broader range of activities. These include theselection of health sector goods, issues concerning themanufacture of goods to be purchased for the project,appropriate delivery to and storage within the recipient healthsystem, and stringent monitoring and assurance of qualitythrough inspection and product testing, in addition to thetransparent, fair, and cost-effective management of thepurchasing of goods. Central to the process is management anddirect oversight of all the stages contained in this broaderprocurement definition (see figure 2).

4 Based on the model drug supply cycle presented in Managing Drug Supply, MSH and WHO.


Figure 2

PROCUREMENT{...................... ........................ ......................................... .................. ..................

Managemen P nManagement

<~~ ( ~Management j\ evr Oversight

o j..........................................0 \ | . ~~~~~~~~~~~~~~Storage.|

~~~ + I .'' '' ~~~~~~~~~~~Q-ua'iity''--.r'| ~~~~~~~~~~~~~~~~~~~~Control .

_ 1 "' J ;;~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~....................

;~~~~~t on

............................................. .........................


3.2 Assessments

3.2.1 Country Level

3.2.1.1 It is important that task teams understand that the countryenvironment in which procurement of pharmaceuticals,vaccines, or contraceptives occurs is changing in manycountries. Where traditionally drug supply management forthe public sector was almost always managed via aninternal vertical system involving centralized managementof both procurement and logistics, many countries areexploring alternatives due to the poor performance of suchcentralized systems. The five main models are:

* The traditional central medical store model, withprocurement and distribution managed by a centralgovernment agency that is part of the Ministry ofHealth. Even in this model, some aspects of supplysuch as transport may be contracted out.

- The autonomous supply agency, whereby a centralstore is managed by an autonomous agency reporting tothe government or by a private firm under contract.

* Decentralized procurement, with orders to suppliersplaced by regional, district, or local facilities followedby direct delivery to the ordering agency by thesupplier. Procurement contracts may be managedcentrally, regionally, or locally in such a system.

* A "prime vendor" system, with many variations, inwhich one agency (again, at central, regional, or locallevel) bids and contracts with any number of supplierson the price of drugs. A separate bid and contract isestimated with a single distributor, the prime vendor, tomanage some or all aspects of logistics. The suppliersthen deliver to the prime vendor for distribution.

* A fully private supply system in which health servicesand drug/commodity supply are provided by privateproviders (for-profit or nongovernmental organizations[NGO]). Government may or may not takeresponsibility for paying private providers for careprovided to certain categories of patients.

3.2.1.2 There are many variations on these five models, withvarious potential roles for government, private firms, andNGOs. In some cases a "mixed" supply system may exist(or should be considered) with different models used atdifferent levels of the supply system or for specific types ofproduct.


3.2.1.3 The task team should consider with clients both the existingsystems and potential alternatives (which might bedeveloped and implemented with Bank support) whenworking with clients who are designing projects involvingprocurement of pharmaceuticals, vaccines, orcontraceptives. For more information on these supplysystem models, see chapter 6 (Drug Supply Strategies) inManaging Drug Supply, listed in references.

3.2.1.4 It is advisable that, prior to determining the procurementmodel for a project supported by the Bank, an analysis ofboth the public and the private pharmaceutical sector becarried out. Project identification and preparation teamsshould consider carefully various options for managingeach aspect of the procurement cycle as illustrated in theprevious section in the context of the broader sectoralassessment. The assessment of procurement options shouldbe structured to achieve necessary information objectives,and the team carrying out the assessment and optionsanalysis should include at least one expert in drug/healthcommodity supply management. Task team leaders maywish to refer to chapter 4 (Pharmaceutical Supply SystemAssessment), chapter 13 (Managing Procurement), andchapter 21 (Managing Distribution) in Managing DrugSupply (see references) to obtain concrete ideas forstructuring the pre-project country supply systemassessment during project preparation. Many assessmentissues are also covered in the Bank's instructions forassessing procurement agency capacity, discussed in thenext section.

3.2.2 Procurement Capacity of Implementing Agency

3.2.2.1 The capacity of the party(ies) designated to carry outprocurement must be examined for each project so thatappropriate support and technical assistance can beprogrammed into the project. The Bank has issuedinstructions regarding Assessment of Agency Capacity toImplement Project Procurement to guide evaluation of thecapacity of the implementing agency and of the adequacy ofprocurement and related systems in place to administerprocurement in general, and Bank-financed procurement inparticular. The capacity assessment reviews the followingareas: legal aspects, procurement cycle management,organization and functions, support and control systems,record keeping, staffing, the general procurementenvironment, and private sector assessment. Such anassessment can identify weaknesses in the systems andprocedures for procurement, which may be able to be


addressed through institutional capacity-building activitiesfinanced by the project.5

3.2.2.2 The evaluation also includes an assessment ofadministrative, political, and financial risks to theprocurement process. This produces a risk grading for theprocurement implementing agency, identifies areas whereaction can be taken before and during projectimplementation to improve long-term capacity of theinstitution, and sets the intensity and nature of Banksupervision of the procurement. The intention is that priorreview thresholds for the procurement of health sectorgoods would be determined from the risk assessment.

3.2.3 For projects involving the procurement of health sector goods,several specific issues need to be addressed.

3.2.3.1 Most of the items procured under Bank-financed healthprojects that are classified as pharmaceuticals, vaccines, orcontraceptives have product specifications and qualitycontrol requirements that are normally regulated andmonitored by the governmental agency responsible for foodand drug regulation (FDRA) in the borrowing country. TheFDRA should have the capacity to implement localregistration procedures and monitor GMP. In manydeveloping countries, however, either there is noappropriate legislation to regulate these products, or if suchlegislation is in effect, the FDRAs are too weak to exerciseadequate control. Consequently assessing, and if necessarystrengthening, the capability of the local FDRA to monitorand control quality must be made an essential part of theproject appraisal and the procurement capacityassessment-regardless of method of procurement orsource of financing-to safeguard over the long term thehealth of the population in the borrowing country. Inaddition, it is critical to define proper technicalspecifications and qualification criteria and plan foradequate pre-dispatch inspection and testing of goods. Tothat effect, project staff should ensure that the documentaryrequirements stated in ITB Sub-Clause 6.4 (b) be reviewedbefore the bidding documents are issued.

3.2.3.2 Should inadequacies be identified in the FDRA, monitoringand inspection of shipments by another qualifiedindependent regulatory and testing agency acceptable to theborrower and the Bank could be made a condition of the

Task team leaders can access the HNP Advisory Service of the Bank's Help Desk Network for informationon sources of specialized technical expertise (organizations and individual consultants) from which toidentify resources to assist in the completion of such assessments, if required.


loan for all ICB and other procurement to be financed by theBank. An alternative for smaller value procurements wouldbe to utilize the procurement expertise of a qualified,reputable UN or NGO agency (see sub-paragraph 3.11.7).

3.2.3.3 The acceptability of the country drug registration processneeds to be reviewed. Where this is inadequate orinefficient, steps must be taken to improve the registrationprocess so that it does not impede the effectiveness of thecompetitive bid process by deterring potential bidders (seesection 3.8).

3.2.3.4 Where local quality control systems and functions arejudged inadequate, consideration should be given tofinancing technical assistance to improve the situation in thecountry concerned, either as part of the project or through analternative grant mechanism.

3.3 National Policies

3.3.1 National policies on pharmaceuticals, vaccines, contraceptives,nutritional supplements, and medical equipment can address broadissues relating to acquisition and use in the country, and theyprovide a legislative and regulatory setting within whichappropriate decisions about the procurement characteristics ofhealth sector goods can be made. In the absence of such policies,or equivalent national laws and regulations, the selection ofsuitable health sector goods and the cost-effective procurement ofappropriate quality products become more difficult tasks.

3.3.2 A national drug policy provides a foundation for managing drugsupply and a context within which to implement procurement ofpharmaceuticals, vaccines, contraceptives, and nutritionalsupplements. Such a policy generally embodies the goals set bythe government for the pharmaceutical sector, presents thestrategies designed to achieve those goals, and provides aframework for coordinating the activities of the public and privatesectors, nongovernmental organizations, donors, and otherinterested parties. Comprehensive, officially adopted policies arelikely to contain health-related goals-improving the access of thewhole population to essential drugs, ensuring safety, efficacy, anddrug quality, and prompoting rational prescribing, dispensing, anduse of medicines-as well as economic and national developmentaims. Economic goals generally include lowering the cost ofdrugs, control of foreign exchange expenditures, and the provisionof employment in pharmaceutical supply.

3.3.3 The establishment of a national drug policy will require stronggovernment will to oversee a process that correctly identifies thekey problem areas and involves the principle actors (many ofwhom have distinct self-interest) to develop appropriate

Technical Note for the Procurement of Health Sector Goods II

legislation and introduce regulations as appropriate and thenmonitor and enforce them. The components of a national drugpolicy depend upon the country situation and may include thefollowing areas: a legislative and regulatory framework, soundprinciples of drug and vaccine selection, the supply and rationaluse of drugs, economic strategies for providing pharmaceuticalproducts in the public and private sectors, the development ofhuman resources, and clear monitoring and evaluation roles.

3.3.4 A national drug policy improves the procurement of health sectorgoods financed by Bank loans in two key areas. The developmentof a national essential drug list (EDL) within the drug policyencourages the selection of appropriate and cost-effective healthsector goods, and the establishment and operation of a regulatorysystem ensures goods of appropriate quality are procured. Itshould be recognized that experience from a number of countriesindicates that the development and implementation of acomprehensive national policy does, and ought to, take severalyears (and may be regarded as an ongoing exercise). Projectprocurement should not be delayed while awaiting acomprehensive policy. In the interim, use can be made ofinternationally accepted instruments such as the WHO model listof essential drugs. However, the project will have to includeacceptable measures to mitigate the risks created by the lack of apolicy. Consideration should be given during project design to thefinancing through the loan of such policy activity or componentsas is deemed imperative to successful project implementation.

3.3.5 A national policy for vaccines is established to manage theimportation and ensure the safety, quality, and efficacy of vaccinesused in immunization programs. Such a policy should include theestablishment of a national control authority for biologicalproducts' (probably as part of a national drug regulatory body)with responsibility for licensing vaccines for use in the countryand assessing the quality of imported vaccines lots (and, whereappropriate, those manufactured locally). The national authoritywould also operate a surveillance system to monitor the vaccinesin use and take appropriate action should adverse reactions occur.

3.3.6 Family planning policies may initially determine the extent ofchoice in contraceptive methods to be made available, with manyprograms aiming for a broad method mix to meet the varyingneeds of couples wishing to space or to prevent pregnancies. Apolicy may delineate which cadre of health sector personnel mayrecommend and administer particular methods. For example, it

6 Indicator-based assessment tools to determine the status of national drug policies and regulations have beendesigned by WHO and MSH (see reference list).Further information is contained in WHO's Guidelines for National Authorities on Quality Assurance forBiological Products, 1992.


may be decided that the condom can be distributed by community-based workers, hormonal methods require a higher level of clinicalexpertise, and the IUD and implants may be provided only bytrained doctors. The classification allocated to different methodsby the national regulatory authority can affect quality controlissues. Hormonal methods are generally referred to as drugs;IUDs are usually classified as medical devices, and condomssometimes as consumer or hygienic products. For condoms to bemade to meet higher standards of performance and quality, it maybe more appropriate to classify them also as medical devices.

3.3.7 A national policy on medical equipment for the public sector canaim to ensure that scarce resources are utilized to obtain priority oressential equipment. A well-designed policy can also help ensurethat the equipment is compatible with expertise in the publicsector, that servicing and maintenance is available, that theequipment is suitable for the facility environment, and thatcomplementary equipment is on site (generators, surgeprotectors).8

3.4 Local Production

3.4.1 In many developing countries, local manufacturing capacity ofpharmaceuticals is either nonexistent or is limited to a smallnumber of common products and "galenicals" (i.e., tinctures andspirits). As a result, most procurement, both public and privatesector, is from foreign sources. Procurement opportunities cannotbe reserved only for local manufacturers, and if they participate inICB, LIB, or NCB procurement, they must be held to the samequality and other standards as other bidders. If domesticproducers meet the standards, the Bank allows borrowers toprovide a small margin of preference in the evaluation of bids,applying the preference to goods manufactured in the country ofthe borrower.

3.4.2 Only a small number of countries outside of the developedcountries have the capacity to produce vaccines. This productionis usually limited and intended for programs within the country.Of these manufacturers, only a portion manufacture vaccines to aquality sufficient for safe and reliable use in immunizationprograms. If they meet internationally recognized qualitystandards, however, they must be allowed to compete.

3.4.3 Contraceptives are produced in about twenty-five developingcountries,9 though with the main exception of condoms, these are

8 WHO has assisted a number of countries in the drafting of a national policy on medical equipment, copiesof which may be obtained from WHO, CH- 1211 Geneva 27 - Switzerland, and it is preparing a Guide forthe Formulation of a National Healthcare Equipment Policy to be available in 2000.

9 Contraceptive Manufacturing Overview Draft Paper (#10) prepared by PATH for the World Bank.


primarily for consumption in the country of manufacture.Fourteen of these twenty-five countries are also the largestconsumers of contraceptives. Oral contraceptives are the mostcommonly manufactured products, followed by condoms andinjectable contraceptives.

3.5 Centralized versus Decentralized Procurement

3.5.1 A major issue affecting the overall success of a health project, andwhich must therefore be resolved early in the project cycle, relatesto who in the borrower's country will be responsible for projectprocurement. The service providers who utilize health sectorgoods-central, state, regional, or municipal hospitals, healthcenters, clinics, public and private pharmacies, etc.-may arguefor a decentralized approach, which gives them greater controlover the process. In many situations, however, the governmentmay have an established centralized purchasing unit. The CountryProcurement Assessment Review, or the Assessment of AgencyProcurement Capacity, should play a key role in addressing thisissue by identifying the risks associated with either approach.

3.5.2 The Bank's interest is in the procured health sector goods reachingthe population that needs to benefit from their purchase. This canbe achieved only when a competent implementing agency ischosen and equipped with all the skills needed for carrying outand/or monitoring all phases of the procurement, manufacturing,inspection, delivery, warehousing, and distribution, as well ascontract administration. The selection and quantification (seesections 4.1 and 4.2) of products may be the responsibility oftechnical or program staff or the procurement office.

3.5.3 Centralized Procurement

3.5.3.1 Advantages

Centralized procurement offers some potential advantages inlowering the cost of the goods and in optimally utilizingscarce technically skilled procurement personnel. Lowerproduct costs can sometimes be obtained through centralizedprocurement because of procurement in bulk and moreeffective implementation of competitive procurementprocesses. Total administrative costs should be lower forprocurements managed competitively by a central unit ratherthan a number of regional (or lower) administrative bodies.The expertise to prepare and evaluate competitiveprocurements, especially international ones, is most likely toreside at the central level. Central procurement minimizesfinancial and accounting management requirements ofprocurement.

3.5.3.2 Issues

To make sure enough of the right health sector goods are


ordered, the central purchasing agency must interact withservice providers throughout the system while it preparesthe bidding document and technical specifications. Onepotential disadvantage of centralized procurement is thedifficulty in making the product available in a timely andefficient manner to the consumer. This is a particularconcern if the purchasing agency's control over thedistribution chain is weak and coordination between it andthe lowest link in the system is poor.

3.5.3.3 Centralized procurement is indicated for large fixed-quantitypurchases of pharmaceuticals and nutritional supplements.National immunization and family planning services areoften separate vertical programs, with the management anddistribution of vaccines and contraceptives a centralizedfunction. A trend toward the integration of vertical supplyprograms is discernible in the 1990s. This trend, inconjunction with the limited number of internationalmanufacturers of reliable quality vaccines andcontraceptives, suggests that centralized procurement is thepreferred mechanism. Medical equipment procurementshould also be undertaken centrally, in part to takeadvantage of multiple unit purchases, but primarily becausethe expertise to procure specialized capital medicalequipment is unlikely to be available or easy to maintain in acost-effective way at lower administrative levels of thehealth system.

3.5.4 Decentralized Procurement

3.5.4.1 Advantages

Procurement by lower administrative levels may bebeneficial for emergency requirements, for products that areavailable from a number of national suppliers, products forwhich only a small quantity is needed, or items notcontained on the national essential drug list. By being closerto the service delivery point, lower levels should have abetter understanding of actual requirements. In situationswhere estimated quantity supply contracts are feasible andpreferable, at least some aspects of procurement can readilybe decentralized. (With estimated quantity contracts, theprocurement agency bases contracts on estimated ordervolume and orders are placed throughout the contract periodbased on actual need.) Decentralized procurement alsooffers an opportunity for institution building outside of thecentral geographical areas of the organization as staff atlower administrative levels develop expertise.

3.5.4.2 Issues

Staff at lower levels may possess less expertise in


quantification or quality assurance than at the central level.Staff may not be available to dedicate to manage andmonitor physical and financial procurement activities. Onthe Bank side, the task of assessing the capability ofdecentralized units to carry out procurement and the cost ofany technical assistance is increased.

3.5.5 Selective Decentralization of Procurement Responsibilities

A range of decentralized options (both through devolution ofresponsibility from the center to more peripheral sites and bydivestment of responsibility to an organization outside of thegovernment) exists short of allowing or expecting lower-levelhealth facilities (or even users) to manage all aspects ofprocurement. Some components of procurement may be assignedto lower administrative levels while others remain the prerogativeof the central level. For example, bidding might be managedcentrally, while district offices or hospitals could order healthsector goods from the suppliers previously selected through acentrally managed bid process. Distribution could be contractedout to an autonomous agency or a prime vendor following acentrally managed process that would set the price.

3.6 Prequalification versus Postqualification

3.6.1 A number of steps may be undertaken when evaluating newsuppliers, including formal supplier registration by theprocurement agency, reference checks with previous customers,the purchase of small quantities for trial or testing, and informalinformation collection. Countries that do not have functionalquality assurance testing laboratories should make energeticefforts to confirrn the references of new suppliers. Such countriesshould buy only from suppliers who are known and proven toprovide quality products. Institutions such as UNICEF and WHOmay be able to assist countries in this effort.

3.6.2 Both pre- and postqualification, if properly managed, can help toeliminate substandard suppliers. Prequalification evaluatessupplier capacity, before bids are solicited for specific products(based on documentation of product quality, previousprocurement history, and other customer references). Substantialtime and effort may be required to establish an initial list ofprequalified suppliers, especially if a policy is in place toprequalify suppliers separately for each product (drug, vaccine,etc.). Prequalification, however, expedites bid evaluation andcontract award since the lowest evaluated bidder is deemed to bequalified. There is concern that suitably reliable suppliers may beexcluded from the list if the prequalification process isadministered unfairly. This concern can be eliminated if theprequalification criteria are clearly specified and approved by theBank, and the procedures are fully and consistently applied to all


candidate suppliers (see annex 2, Guidelines for Prequalification).Established procurement systems commonly implement a form ofICB preceded by prequalification, soliciting bids only fromsuppliers who have been prequalified.

3.6.3 Procurement offices using ICB with prequalification shouldperiodically assess the market to seek out potential new suppliersin order to maintain competitive pressure on establishedsuppliers. Once this status is achieved, the supplier remainsprequalified for two years unless there is a reason to review thesituation; for example, if there were product recalls ornoncompliance with awarded contracts. As a matter of course,the list of prequalified suppliers should be reviewed every twoyears. Suppliers who did not prequalify at the outset of the projectshall be allowed to apply for prequalification again at a later stagein the project's life.

3.6.4 The Bank supports prequalification for the procurement of healthsector goods, including pharmaceuticals, vaccines, and condoms.Prequalification contributes significantly to the purchase of high-quality products while maintaining the desired competitive natureof the procurement process. Should the procurement capacity ofthe implementing agency be inadequate to satisfactorilyundertake the prequalification of suppliers, the borrower maycontract for the assistance of outside consultants or internationalagencies such as UNICEF to carry out the prequalification whileit develops its own capacity. Such assistance, which could befinanced by a grant, must also include measures to strengthen theborrower's capacity to undertake prequalification for futureprojects.

3.6.5 It is particularly recommended that prequalification beundertaken for vaccines to ensure the quality and acceptability ofthe product as well as the supplier. The suggested procedure forprequalification is through licensing of the vaccine by thepurchasing country's regulatory body. The result is a list ofvaccines (from specific manufacturers and with specific technicalattributes) that are acceptable and safe to procure. Should thenational regulatory body be too inexperienced to conduct theprequalification exercise, the borrower may be permnitted to relyon vaccine suppliers prequalified "in principle" by WHO,'0 byobtaining a Statement of Known Good Quality from WHO, or byselecting vaccines manufactured and licensed in countries withstrong, competent regulatory bodies."

'° An "Address List of Suppliers Approved in Principle for the Supply of Vaccines to United NationsAgencies" is contained in Procurement of Vaccines for Public Sector Programs: A Reference Manual,WHO/GPV, Geneva, 1998. A list of vaccine suppliers to UN agencies, as of November 1998, is attached atthe end of the document. For a current edition of the list, contact: [email protected] or [email protected] Procurement of Vaccines for Public-Sector Programs: A Reference Manual for more information.


3.6.6 Postqualification is where the supplier qualification exercise iscarried out after bids are submitted in response to an open bidprocess, commencing with the supplier submitting the lowestevaluated bid. The process is similar to that for prequalification,with supplier(s) being assessed with respect to registration status,previous performance, and product quality. Only if the apparentlowest evaluated bidder lacks acceptable qualification wouldmore than one postqualification have to be carried out.Postqualification can result in substantial delays in cases wheremost of the lowest bids are from suppliers with no track record inthe purchasing country, particularly when the local procurementagency has limited capacity to communicate with potentialinternational references. Should delays in postqualification occur,however, following the bid opening, it may be necessary to re-confirm prices, or even require re-bidding, before finalizing thecontract. The validity period should therefore be deliberately setto allow adequate time for postqualification. Providing clear,internationally accepted standards and requirements at the outsetmakes the process easier.

3.7 Product Quality Assurance

3.7.1 The quality of health sector goods is a critical factor insafeguarding the health of the population of the country in whichthe goods are consumed. Poor quality pharmaceuticals, vaccines,and contraceptives are unlikely to fulfill their purpose of curingillnesses, preventing diseases, or controlling fertility. In worst casescenarios they can be detrimental to health. Ensuring productquality is an essential component of the procurement processachieved through preparation of comprehensive technicalspecifications, purchasing from qualified manufacturers andsuppliers, and appropriate testing and surveillance of the goodsthroughout the delivery, customs clearance, warehousing, anddistribution process. Once in the distribution system, ensuringquality requires that a reliable system be in place to monitor expirydates and storage conditions and the operation of a system torecognize and respond to product defects and adverse reactions. Iffinal delivery systems are weak, the Bank would recommend thatthe final delivery process be handled by separate contract with anexperienced qualified freight forwarder.

3.7.2 WHO has established good manufacturing practices (GMP)similar to those enforced by the national drug control authorities inindustrialized countries. The GMPs establish criteria forpersonnel, facilities, equipment, materials, manufacturingoperations, labeling, packaging, quality control, and stabilitytesting. Most countries mandate compliance with national GMPstandards before issuing new manufacturing licenses and enforcethis through a system of inspections and regulatory controls. Anyviolation can result in prosecution or suspension of the offender'smanufacturing license, although enforcement of this provision


requires a strong regulatory agency (RA) and politicalendorsement for regulatory action. Around 140 national drugcontrol agencies participate in the WHO Certification Scheme onthe Quality of Pharmaceutical Products Moving in InternationalCommerce. They agree to certify that drugs, vaccines, andappropriate contraceptive methods (e.g., hormonal) are registeredin the exporting country and that the manufacturer's facilities havebeen inspected and comply with GMPs.'2 Borrowers can stipulatethat bidders arrange to have the RA in the producing countryprovide a product certificate issued under the WHO scheme tosupport their bid. The credibility of such a certificate dependslargely on how reliable and responsive the authority is in theexporting country, its capability to make adequate GMPinspections, and the capability of the importing country's authorityto assess the authenticity or validity of the certificate. Particularcare may be required if the certificate is submitted through themanufacturer or importing agent rather than received directly fromthe issuing RA. In this case, the borrower is advised to seeksupplementary references, for example, from purchasers withprevious experience with that bidder. These aspects can best beaddressed early in the procurement process as part of aprequalification exercise.

3.7.3 Marketing authorization (registration in the country of origin) isroutinely applied for by the supplier. If granted, registration shouldindicate compliance with drug regulatory requirements andsatisfactory quality for drugs circulating in the country. Theprovisions of marketing authorization (MA) of drugsmanufactured only for export vary between producer countries fora number of reasons. Therefore, this MA cannot be consideredadequate proof of quality. In these cases, additional guarantees ofquality-for example, compliance with WHO certification-should be obtained from the supplier. Purchasers need to be awarethat apparently standard quality certificates may indeed be basedon varying parameters, that MA and GMP are both issued byauthorities in the country of origin, and that their value dependsupon the capacity and diligence of the issuing FDRA.

3.7.4 Purchasers can include quality testing of products as part of theprocurement and, where appropriate, importation process. Forcertain products, such as condoms and vaccines, it is essential totest for quality before shipment; for other products, testing can bedone after receipt. The costs of testing in relation to the value ofgoods may need to be taken into account. Not all developingcountries have the necessary facilities and technical personnel incountry to conduct complex quality assurance testing on healthsector goods. In these circumstances, there may be regionalfacilities that could be engaged. Alternatively, there are a number

12 A Model Certificate of a Pharmaceutical Product established by WHO is appended in annex 4.


of international laboratories, including regional quality controllaboratories approved by WHO, that can undertake appropriatetesting on drugs, vaccines, and contraceptives.'3' 4 Projectfinancing may be needed to support the use of alternativeresources.

3.7.5 Capital medical equipment should be tested in place and the finaluser (or "owner") at the health facility sign off on acceptance ofthe items, following appropriate installation procedures such ascommissioning and calibrating the equipment.

3.7.6 Developing countries generally lack the pharmaceutical or vaccinesurveillance systems to monitor product failures, adversereactions, or international recalls. Thus, suppliers are required toinform the borrower of any such event and to replace the affecteditems if a similar action has been taken in the manufacturer'scountry of origin (see clause "Warranty" of the GeneralConditions of Contract of the SBD). The FDRAs in borrowercountries should also establish direct communication channelswith FDRAs in the United States, Europe, and Japan to obtaininformation about recalls and their regulatory actions.

3.8 Marketing Authorization (Product Registration)

3.8.1 Requiring that bidders register individual products locally inadvance of bidding potentially limits competition. Often, largemultiproduct companies register their products to exploit privateand public sector markets and to promote them in the market. Formost bidders who are not already active in a local market,however, going through the expensive and time-consumingproduct registration process would not be justified given theuncertainty of success in the ICB process. Making productregistration a precondition to bid for a contract financed by theBank would in effect force every primary manufacturer to registerall products of potential interest in all Bank member countries.This is unreasonable, since pre- or postqualifying bidders based ontheir experience and quality control facilities, if done carefully andwell, serves virtually the same purpose as registration. To beacceptable to the World Bank, therefore, product registration canbe accepted only as a prior condition of contract signing, notbidding.

3.8.2 If, for statutory reasons, product registration is necessary beforedrugs are allowed entry, the Bank should, in its ongoing dialogue

W3 HO/GPA's Specification and Guidelines for Condom Procurement lists international testing laboratoriesand sampling services. Make reference to the compendium of materials published and distributed by WHO:WHO/RHT/FPP/98/15 and UNAIDS 98/12. Available at http://www.who.ch/rht.A partial list of testing laboratories for vaccines is contained in Procurement of Vaccines for Public-SectorPrograms: A Reference Manual.


with borrowers, encourage them to establish a fast-trackregistration process. This would be designed to automaticallyregister new pharmaceuticals or vaccines offered by successfulbidders on payment of a reasonable fee, provided thedocumentation and samples submitted as part of the bid confirmthat they meet all the qualification criteria established in theBidding Documents including proof of registration and approvalin the country of origin. The registration process can be fasterbecause manufacturers are not requested to submit their ownclinical and toxicological analysis but may rely upon previouslypublished literature. To expedite the process, the purchaser shouldinclude in the BDS full details of the registration authority'5 andbidders can apply even before it is known who will be awarded thecontract. The accompanying registration package should clarifythat the formal registration process is not part of the bid and thatthe original registration forms should not be returned to thepurchaser but sent directly to the appropriate regulatory authority.

3.8.3 Another way to accomplish "fast-track" registration could be forthe country's regulatory authority to formulate a policy that allowsa product to be registered if it can be proven that the product isregistered in another country for importation and use. In this case,the purchaser will need to establish that the selected country (ortrade group) has in place proper and appropriate standards andprocedures to assess the quality of the goods.

3.8.4 In the end, if registration is unreasonably denied to a qualifiedbidder, the Bank cannot finance the contract.

3.9 Importation Issues

3.9.1 Smooth and rapid importation of health sector goods is importantso that the goods are quickly made available to the distributionsystem and hence to the user, and also to minimize the opportunityfor the goods to age, be damaged, or be mislaid at the ports.Delays in importation shorten availability of the shelf life ofpharmaceuticals, vaccines, and contraceptives, and unless properlystored, the efficacy of the product may be substantially impairedby climatic extremes.

3.9.2 The requirements for, and the steps in, the importation processshould be cataloged before procurement activities commence,which will facilitate the efficient transfer of goods from port ofarrival to the implementing agency warehouse and distributionsystem. This review, which ideally should be done in parallel withand should be viewed as an integral part of the agencyprocurement capacity assessment, should also identifyweaknesses, bottlenecks, or inconsistencies and hence areas whereamendments or improvements to policy, infrastructure, or systems

'5 Include contact person, e-mail and street addresses, and telephone and fax numbers.


can be beneficial. Short-term measures needed to bring the qualityof the system up to minimum acceptable levels must beincorporated into the project design. The following points suggestareas that require attention:

e Are items on the project procurement list legally able to beimported?

* Procedures and time lines for obtaining import license.* Import duties. Timeline for payment process.* Exemptions to import duties.* Documentation necessary for importation clearance.* Rate and initiation of demurrage charges.* Special handling requirements of products (for example,

refrigerated storage for vaccines).* In-house clearing or employment of a clearing agent?* Is the customs storage capacity adequate, secure, and suitable

for safeguarding product quality, including the presence ofrefrigeration facilities?

3.9.3 Guidelines on import procedures for pharmaceutical productsdeveloped by WHO are based on the premise that "public healthconsiderations demand that pharmaceutical goods should not betreated in the same way as ordinary commodities." In particularthe guidelines propose that importation of pharmaceutical productsshould be undertaken in line with national drug policy regulationsor other relevant legislation and enforced by the national drugregulatory authority. Importation should be undertaken only bylicensed agencies (including government procurement units) thatprovide the customs authorities with appropriate documentation.'6

3.10 Logistics

3.10.1 The objective of a World Bank-financed project is not simply toprocure a given quantity of identified health sector goods. Aproject is undertaken to improve a country's health program. Tothat end, vaccines are needed for prevention, pharmaceuticals forcuring illnesses, contraceptives to meet reproductive healthneeds, and nutritional supplements to improve nutrition. Peoplewho use these products are located throughout the country andare most often reached by a network of public health facilitiesand community health workers. The pharmaceutical,contraceptive, and vaccine distribution chains often extendthrough federal, regional, provincial, and/or district warehousesto reach the user. Unless these distribution systems operateeffectively, project objectives cannot be met.

3.10.2 As a result of weak management, poor communications, and/orunreliability of transportation, it can take three to six (and insome cases as long as twelve) months for stocks to reach the user

16 Guidelines on Import Procedures for Pharmaceutical Products, WHO, 1996.


after they have reached a central warehouse. For limited-shelf-life items this is a serious problem, especially if shelf-lifestandards are not rigidly enforced at the procurement stage. Thedanger is that by the time the stock arrives at the site it has to beshipped back to the central warehouse or destroyed because itsshelf life has already expired or there is a lack of capacity toconsume or hold the large quantities received. Stipulating'7 thatall products must have a specific period of shelf life (see annex 3)remaining upon arrival at the port of entry in the borrower'scountry can mitigate the consequences of distributioninefficiencies.'8 But this of itself will not solve the problem ofexpiring stocks if the local logistics are inadequate. If distributionproblems relate to poor communication and management by thepublic sector, the use of a private sector distribution or logisticsagent could and should be considered for the project, and theinclusion of a component in the loan aimed at identifying ways toimprove the system should be considered.

3.10.3 Vaccines, unlike most pharmaceuticals and contraceptives, mustbe kept within certain temperature ranges throughout thetransportation from manufacturer to inoculation center.19 Thus inmany countries, national expanded programs on immunization(EPI) established separate vertical cold chains. The continuousproper operation of the cold chain is essential to maintaining theefficacy of vaccines. Several country programs installedrefrigerators and other cold chain equipment a number of yearsago. An assessment of the condition of the cold chain prior toprocurement, and rectification of deficiencies through the project,may well be necessary to safeguard a valuable investment invaccines.

3.10.4 Satisfactory storage, in terms of capacity and its ability to protectand secure health sector goods, is a vital component of logistics.Though the central-level infrastructure is often most easilyrecognized as a problem area, the status of storage facilities atlower levels in the distribution system should not be overlooked.Inadequate capacity at any level may expose shipments toclimatic conditions that may damage the goods. Arranging forthe delivery of large procurements in multiple shipments can, tosome extent, compensate for such a lack of capacity at the central

7 Clause 15 of the General Conditions of Contract in the SBDs requires of five-sixths remaining on goodswith a shelf life of more than two years and three-fourth for goods with a shelf life of two years or less.Some flexibility may be required in the case of products with a shelf life of less than two years or forproducts of very low consumption where the quantity may not meet a manufacturer batch size and hencewill be provided from stock. In these cases, the SBDs will recommend that three-fourths of the shelf liferemain at arrival at port of entry or in accordance with relevant Incoterm used.

s8 After the supplier has transferred the consignment to the shipper, delays during shipment can be an issuebecause, under CIF and CIP arrangements, such delays are not the responsibility of the seller.

19 Although pharmaceuticals and contraceptives should also not be subject to extended periods in extremetemperatures.


level.

3.10.5 Health sector reform in a number of countries involvesconsideration of the integration of existing, separate, verticaldistribution systems for vaccines, contraceptives, andpharmaceuticals (and sometimes laboratory and other verticalhealth program requirements). The implications of integrationmay also need review during the preparation and appraisal ofprojects, and, where appropriate, finance and a project plan withappropriate technical assistance included.

3.11 Procurement Methods

3.11.1 Regardless of which method is used, a number of activities orsteps need to be taken prior to procurement. The items need to beselected (see paragraph 4.1), quantified (4.2), packaged, andaccurate technical specifications drafted or identified. Byidentifying the range of sources for quality products, a review ofthe marketplace for particular goods will help determine the bestprocurement method to use (see Procurement Method matrix onpages 29 and 30). The Bank's Procurement and ConsultantGuidelines recommend methods to be used with Bank-financedprojects and the circumstances under which other methods maybe used. The information about these methods provided below isfor general guidance only. The method appropriate in specificsituations should be determined in consultation with the Bankprocurement staff assigned to the project. The SBD stipulatesthat pharmaceuticals must be procured from the primarymanufacturer or its authorized agent.

The evaluation of offers or bids for health sector goods differssignificantly between "consumable" items-drugs,contraceptives, nutritional supplements, and vaccines-andcapital medical equipment. In essence, borrowers must make aninvestment decision in the case of capital medical equipment,which encompasses "life cycle costs"-maintenance, softwareupgrades, ancillary consumable items-in the evaluation process.

3.11.2 International Competitive Bidding

3.11.2.1 International competitive bidding (ICB) is the Bank'srecommended procurement method because it ensureseconomy efficiency, and transparency. Section 2 of theBank's Procurement Guidelines provides full details. TheSBDs have been drafted to describe the ICB bidding,evaluation, and contract award process.

3.11.2.2 Generally, to be attractive to international suppliers, ICBprocurements must be relatively large in value. An ICBprocurement comprising many low-value items, however,is likely to be uneconomical and not worth the time and


expense required to administer the ICB process. Inplanning health project procurement, only items that arelikely to be available from the same set of bidders shouldbe packaged together (see section 4.4).

3.11.2.3 The borrower is encouraged to prequalify bidders at thebeginning of an ICB procurement by advertising aninvitation to prequalify for bidding, conducting anevaluation of the capability and resources of prospectivebidders and then issuing the bidding documents only toprequalified bidders. Carrying out prequalification earlyin the project is strongly recommended for pharmaceuticalprocurements because it allows the borrower toconcentrate solely on important quality issues before priceconsiderations are introduced. It is often more efficient tocarry out a broad prequalification for all the health sectorgoods to be procured at the beginning of the project thatwould only need to be updated every two years. Careshould be taken to ensure that the qualification criteriaspecified in the bidding documents match those of theprequalification.

3.11.2.4 The borrower may, with the agreement of the Bank, granta margin of preference in the evaluation of bids under ICBprocedures to bids offering goods manufactured in thecountry of the borrower, when compared with bidsoffering goods manufactured elsewhere.20 Biddingdocuments shall clearly indicate any preference to begranted to domestically manufactured health sector goodsand the information required to establish the eligibility ofthe bid for such preference.

3.11.2.5 The evaluation of bids under circumstances allowingdomestic preference involves initially the classification ofbidders into groups-those offering goods with localcontent of more than, and less than, 30 percent of the ex-warehouse cost and those offering imported goods.Should bids from suppliers offering imported goods be thelowest on a straightforward comparison, then a calculationintroducing a factor for the actual importation duties or 15percent, whichever is less, is introduced.

3.11.3 National Competitive Bidding

3.11.3.1 National competitive bidding (NCB) is a competitive biddingprocedure normally used for public procurement in thecountry of the borrower. It may be the most economical and

20 Further details are contained in appendix 2 of the Bank's Guidelines Procurement under IRBD Loans andIDA Credits (1997).


efficient way of procuring health sector products that areavailable locally from a number of qualified suppliers andtherefore are unlikely to attract foreign suppliers (thoughthere can be no restriction on international suppliersparticipating in the bid process). This can be an appropriatemethod in countries with an active local industry.

3.11.4 Limited International Bidding

3.11.4.1 Limited international bidding (LIB) is essentially ICBconducted by direct invitation to all qualified suppliersand without open advertisement. This may be a moreappropriate method when there is only a limited numberof potential suppliers, such as for most vaccines, and somecontraceptives like the Copper T IUD.

3.11.4.2 The task team leader must ensure that the LIB short-listproposed by the borrower includes all qualified suppliers,including national ones (provided they are approved bythe national FDRA), to ensure competitive prices 21

Agencies such as UNICEF have lists of qualified suppliersthat can be accessed by Task Team Leaders (see list ofcontacts at end of document).

3.11.5 International or National Shopping

3.11.5.1 The basis of shopping is the comparison of pricequotations obtained from several local and/or foreignsuppliers. To ensure competitive prices, it is usual tosolicit quotations from at least three suppliers (forinternational shopping from at least two differentcountries). This is an appropriate method for procuringsmall volumes of readily available off-the-shelf goodssuch as galenicals.

3.11.6 Direct Contracting

3.11.6.1 This method is used in those cases where the health sectorgood is available from only one source, e.g., thecontraceptive implant Norplant. It is the least favoredmethod of procurement because in the absence of thecompetitive element it is more difficult to determinewhether the prices quoted are economic and reasonable.Therefore financing for such goods should generally be

21 The Vaccine Supply and Quality Unit of the Global Program for Vaccines and Immunization at WHOmaintains a list of vaccines manufacturers who are acceptable in principle for the supply of specificvaccines to UNICEF and other UN agencies (see Procurement of Vaccines for Public-sector Programs: AReference Manual). International Pharmaceutical Manufacturers' Associations should be able to advise onsources for drugs and medicines. UNFPA can advise on contraceptive manufacturers.


minimized, if possible, in project design. This may not bepossible, however, and some direct contracting can beallowed on Bank-financed projects if it can bedemonstrated that it will achieve the most cost-effectivehealth solution for the project.

3.11.6.2 Borrowers should plan their negotiating strategy verycarefully using historical prices received and the drugprice bulletins issued periodically by, for example,UNICEF or Management Sciences for Health (MSH) todetermine the reasonableness of the price offered from thesingle bidder.22 Similar information sources are availablefrom WHO and UNFPA. With few exceptions, the pricesgiven in these publications for pharmaceuticals, vaccines,and raw material reflect the best prices available in themarket.

3.11.7 Procurement from United Nations Sources or OtherAgencies

3.11.7.1 In emergencies resulting from famine, floods, wars, theinflux of refugees and epidemics, poor planning, orforeign exchange scarcity, the immediate procurement ofpharmaceuticals, vaccines, or nutritional supplements isnecessary to effect deliveries in the shortest possible time.In such emergencies or where the number of items is largebut the overall value is small, procurement directly fromestablished United Nations agencies such as UNICEF, andnonprofit organizations such as the InternationalDispensary Association (IDA) or the Equipment forCharitable Hospitals Overseas (ECHO), would beacceptable. These agencies procure and stock commonessential items for supply to their own constituents andcan supply limited quantities to others quickly on request.The total amount of procurement directly from theseorganizations on any given project, however, shouldremain small and used only when packaging for ICB is notpossible, i.e., no more than US$5 million for the UNagencies and US$250,000 for the NGOs. Some agenciesalso stock and supply WHO emergency kits of drugs andmedicines appropriate for such situations.

3.11.8 Use of Procurement Assistance or Agency Services from UNor Other Agencies

3.11.8.1 UN agencies or private firms with experience in healthsector goods procurement can be hired to provideprocurement consultancy services or to act as

22 See reference list for details of how to obtain price comparison data.


procurement agents on Bank-financed projects, providedthey strictly follow Bank procurement procedures asincorporated in the loan agreement. In general, it isacceptable to use UN agencies to procure certain items orservices that they are experienced in procuring for theirown operations and where the borrower is not equippedto handle the process efficiently on its own. For example,UNICEF23 procures vaccines, drugs (primarily thoseintended for children), medical equipment, and UNFPA24

contraceptives and some medical equipment. WHO25 isprepared to handle the purchase of nonstandard vaccines,drugs, and medical equipment for public sector needs.

3.11.8.2 The selection of UN agencies as procurement consultantsor procurement agents is governed by the Guidelines forthe Selection and Employment of Consultants by WorldBank Borrowers. These guidelines stipulate that in theselection process the private sector and UN agenciescompete on an equal basis when offering consultancyservices to borrowers. Because UN agencies are notprofit-oriented entities, however, they have certaincommercial advantages that must be neutralized in theselection. This is done by employing the Quality-BasedSelection process. If a UN agency wins the competition,the Bank permits use of a different contract format thanthe one stipulated for private firms, the standard contractfor consulting services from UN agencies.26

3.11.8.3 In the case of single-source selection, the justification forexclusive use of UN agencies must meet the same criteriaas applied to any other consulting firm and set out in theguidelines. No special advantages are given.

3.11.8.4 It should be noted that UNFPA's and UNICEF's regulationsrequire that they receive advance payment for the goods theywill be procuring on behalf of the borrower.27

3.12 Successful procurement offices ensure continued good performanceby suppliers through a formal monitoring system that tracks lead time,compliance with contract pricing terms, partial shipments, remainingshelf life, compliance with packaging and labeling instructions, and

23 Further information may be obtained from the UNICEF Supply Division, Copenhagen, Denmark, orthrough the country UNICEF representative.

24 Contact the Procurement Unit, UNFPA, New York, for further information or the UNFPA representative incountry.

25 Further details can be obtained from the Procurement Department, WHO, Geneva.26 Standard Form ofAgreement between Bank/lIDA Borrower and UN Agency Concerning the Carrying Out

of Consultant's Services Financed by the IBRD/IDA-June 1996.27 Currently, fees charged by the various UN agencies are as follows: UNICEF charges a fee of 6 percent,

UJNFPA, 5 percent and WHO 3 percent of the value of the supplies.


compliance with other contract terms. The implementing agencyshould maintain a file for each supplier containing copies ofregistration papers, references, special correspondence, complaints,and other anecdotal supplier information. The information systemshould track the number and value of bid contracts awardedchronologically and the value of total purchases from the supplier byyear.

3.13 Guidelines for Selecting a Procurement Method for Each ProductGroup

Subject to the limitations given in subparagraph 3.11.1 above, ICB isgenerally required for all individual procurements valued at $200,000or more, although exceptions can be made in appropriatecircumstances. The following tables present an informal guide-not anexhaustive catalog-of which procurement method may be the mostsuitable for different circumstances for each of the product groups inhealth sector goods. The kind of goods for which each procurementmethod is appropriate, the characteristic of the market for which itwould be pertinent, and the level of expertise required by theimplementing agency are indicated.

PROCUREMENT PHARMACEUTICAL VACCINES CONTRACEPTIVES NUTRITIONAL MEDICALMETHOD SUPPLEMENTS EQUIPMENT 8

Use For multisource products. Not recommended. For multisource products. For multisource products. For multisource products.

Essential drugs not on patent. Condoms. Larger contracts coveringsupplements with a longer Z

7Z ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~0| mr shelf life (more than three Cs

months).

.Market Multiple manufacturers or oo few reputable Multiple anufactuers or Multiple manufactuers or Multiple manufacturers or 5l - *t C Situation suppliers. manufacturers. suppliers. suppliers. suppliers. C

§ 3 c Value of procurement Value of procurement Value of procurement Value of procurement o

sufficiently high to attract a sufficiently high to attract sufficiently high to attract a sufficiently high to attract i

| X number of bids. a number of bids. number of bids. a number of bids. 9

FImplementing agency procurement expertise: I Iigh - Knowledge of sources: preparation and evaluation of bids.

Use Special pharmaceuticals (see Recommended. For those methods of Recommended Acceptable o

-[ w 1::attachment 1). contraception with only afew manufacturers; rUDs,some formulations of

| --Market Li itedrumber-of Lim ite numberof Limited of er of Limited number of Limited numberof

Situation international manufacturers. manufacturers. manufacturers. manufacturers. manufacturers

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l 9^ C) countries, months).

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PROCUREMENT PHARMACEUTICAL VACCINES CONTRACEPTIVES NUTRITIONAL MEDICALMETHOD SUPPLEMENTS EQUIPMENT

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4. Procurement 4.1 Selection of Health Sector Goods to Be FinancedPlanningConsiderations The first step in procurement planning is to select, based on thorough

borrower needs analysis, the specific health sector goods that will befinanced under the project. This paragraph provides guidance aboutwhich items are typically financed by the Bank.

4.1.1 Pharmaceuticals

4.1.1.1 The current range of products available is extensive. For asingle chemical entity (i.e., "basic drug" according tointernational nonproprietary name [INN] or genericchemical terminology), there may be as many as fifty to ahundred brand names and generics in the market from asmany manufacturers. In any distinct therapeutic group,there are many similar pharmaceuticals with only minorvariations. New products frequently come on the marketwith only minor variations in therapeutic effectiveness,but at a much higher price. Intense competition in themarket can create pressure on buyers to recommendinclusion of new brand name products in the variousapproved procurement lists in the country of use. Thismakes the tasks of selection, evaluation, and inventorymanagement extremely difficult. As a result, procureditems can rapidly become superseded by other products,are not prescribed, and have to be disposed of, with aconsequent net loss to the system. This problem has beenaddressed by developed country health administrations,public and private sector hospitals and teachinginstitutions, and developing country governments throughdesigning formularies or essential drug lists for theprocurement of pharmaceuticals and subsequently onlypurchasing items from that list. Anything outside the listwould have to be bought and paid for by the patient unlessmedical necessity has been documented. The formulary isoften established from standard treatment guidelines. Thedrugs required for the optimal treatment then becomeentries on the formulary or essential drug lists.

4.1.1.2 Many developing countries have developed and adoptedan essential drug list or a national formulary for publicsector procurement, using the WHO essential drug list as amodel. These lists generally include the most commonlyneeded pharmaceuticals to treat the majority of problemsseen at public sector facilities. Public sector procurementis generally limited to the essential drug list or nationalformulary and any items outside the list are procured onlyin emergencies. (The WHO essential drug list should bemodified to a particular country situation throughreference to country-specific morbidity patterns.)


4.1.1.3 An essential drug list or formulary list names the drugsconsidered optimal treatment choices to satisfy the health-care needs of the majority of a population. These needsdiffer between health-care levels or regions of a countryso the national essential drug list must take accountdiverse needs. A national essential drug list contains thegeneric name of the drug and the dosage form and mayinclude pack size and other specifications. It can thereforefunction as a supply list from which to select items to beprocured under a World Bank project. Essential drug listsshould be periodically reviewed and revised as appropriateto account for changing product offerings andmodifications in standard treatment guidelines.28

4.1.2 Vaccines

4.1.2.1 In comparison with the number of drugs available in themarket and the range contained in essential drug lists(EDL), the number of vaccines that are likely to bepurchased is limited. Vaccines can be broadly dividedinto those used for universal immunization to preventillnesses in children, and those to protect against diseasesthat affect specific groups or geographical areas.29Consequently, most countries use about six differentvaccines in their immunization program. The choice ofinternational manufacturers for each vaccine is restricted(and is often only a single company). Selection ofappropriate vaccines is made easier by the inclusion ofrelevant vaccines on the country's essential drug list, withreview as the formulary or EDL is updated.

4.1.3 Contraceptives

4.1.3.1 The World Health Organization proposed the inclusion ofhormonal contraceptives and condoms in nationalessential drug lists in the late 1980s. Subsequently, a fewcountries have revised their national essential drug lists toreflect this view, and others in developing new lists areincluding contraceptives.

4.1.3.2 The selection of contraceptives is guided by the policydecisions of the reproductive health departmentauthorities on which methods of contraception to offer inpublic health facilities. Some types of contraceptiverequire providers to have a certain level of clinicalexpertise or knowledge. In some countries only certaincadre of health employees may legally provide a certain

28 The WHO model essential drug list is updated every two to four years.29 See annex 1, paragraph 1.2.3, for more details.


method (for example, insert IUDs). Once a range ofcontraceptive methods has been determined, selectiondecisions differ according to the method.

Oral contraceptives: Select formulation - theestrogen/progestin combination.Multisource products are availablefor some formulations.

Injectables: Selection based on regimen -contraceptive injections are availablein one-, two-, and three-monthpresentations.

Condoms: There are male and female versions.WHO has proposed a specificationfor male condoms for the publicsector. Variations from thisspecification may be made toaccommodate, for example,alternative thickness requirements,type of lubrication, or color.

Implants: There is currently only one productavailable.

Barrier methods: Spermicidal barrier methods areavailable in different forms-jellies,gels, aerosol foam, foaming vaginaltablets.

Mechanical barrier methods aremostly latex or plastic (thediaphragm, cap).

4.1.4 Nutritional Supplements

4.1.4.1 Nutritional supplements are frequently considered forfinancing under Bank-financed health and nutritionprojects, and products are selected according to theincidence of health problems resulting from dietarydeficiencies and related illnesses (for example, vitamin Adeficiency or anemia from iron deficiency).

4.1.5 Medical Equipment

4.1.5.1 The selection of medical equipment30 is particularlyproject driven and should reflect the needs of the level(s)of the health delivery system addressed in the project,since more sophisticated equipment is generally needed at

30 Tools for borrower needs analysis are available through WHO.


higher levels as the range of diagnostic and treatmentservices offered broadens. Following identification of thetype of equipment required, in terms of functionality,selection can be made with reference to a number ofcriteria: Are there products designed for the (developing)country situation? Which manufacturers' products arealready available in country? What servicing, spare parts,or repair arrangements or facilities are easily supplied?Lists of suggested equipment configurations for each levelof health facility are to be found in the Medical EquipmentProcurement Study Report.

Specifically, the recommendations made in the MedicalEquipment Procurement Study Report regardingadditional "maintenance and support services" conditionsfor bidders should be taken into consideration.31 Inaddition, the inclusion of an extended warranty period(e.g., three to five years) priced on a year-by-year basisshould be considered. In case this extended warranty isnot included in the final supply contract, this informationcan be used as input in assisting borrowers to estimate therecurrent budget needed for maintenance services for thenew equipment.

4.2 Quantification of Requirements

4.2.1 Following the selection of the pharmaceuticals, vaccines,contraceptives, nutritional supplements, and medicalequipment to be procured under World Bank financing,the next essential step is to determine realistically, usingthe best available information, the quantities of each itemto be purchased. The quantification exercise shouldproduce an estimation of the financial requirements of theprocurement (see subparagraph 3.11.6.2 for sources ofcost information). If available funds are not sufficient, thequantities need to be adjusted, using a rational process. Anumber of different estimation methodologies can be useddepending upon the product group and the objectives orscope of the project.

4.2.2 Pharmaceuticals

4.2.2.1 Three prime methodologies are available to determine thequantities of individual drugs required. The consumptionmethod employs data on past use (adjusted for stockoutsand projected changes in drug utilization) to project futureneeds. This is likely to be the most reliable methodproviding that the supply pipeline has been consistently

31 Medical Equipment Procurement Study, pages 40 and 4 1.


full and consumption records accurately kept. Onedrawback is that any existing patterns of irrational druguse will be perpetuated. The morbidity method bases theestimate on the expected number of attendances, theincidence of common diseases, and current standardtreatment guidelines. Good morbidity data is essential.This method is most appropriate for calculating need innew programs and for comparing actual use withtheoretical needs. The adjusted consumption methodapplies the pattem of drug use in a "standard" supplysystem to the target system; it is useful in thosecircumstances when the output from the other methods isconsidered unreliable.

4.2.3 Vaccines

4.2.3.1 If no changes are expected in the country's immunizationstrategy, the requirements can be calculated on historicaluse of the vaccines concerned. Alternatively, twomethodologies are available to forecast needs in less staticsituations-the dose-based system and the vial-basedsystem. The former determines need in relation to thetarget population, the expected coverage, and the numberof doses required per client, with an adjustment for awastage factor. The vial-based methodology initiallyestimates the average number of doses required pervaccination session as a basis to determine the optimalsize of vial to obtain, and then uses this factor to calculatethe total quantity of vaccine to be procured. This methodrequires, in addition to the data for the dose-based method,information on the number of immunization centers andthe total number of vaccination sessions per year.

4.2.3.2 The national immunization program's policy ondiscarding multiple-dose vials once opened willsignificantly influence the wastage factor to beincorporated in the estimation processes.

4.2.4 Contraceptives

4.2.4.1 The main methodologies employ historical consumption(or logistics) data, service statistics, or population andcontraceptive prevalence and method mix information. Inthe first option, data on the consumption of eachcontraceptive product over a number of time periods canbe used to ascertain trends and extrapolate need. In theabsence of comprehensive consumption data from servicedelivery points (because of poor reporting or aninadequate information system), it may be possible to uselogistics data on the movement of stock as a proxy for thequantities used. Forecasting requirements from service


statistics requires information on the numbers of clients ofeach method (or brand), attendances at facilities forresupply, and usual dispensing practices (how manycycles of pills or condoms provided to the client at eachvisit). The third methodology transforms proportions ofthe population using particular methods into quantities ofcontraceptives by the application of consumption factors(the quantity of a method needed to provide a year ofprotection against pregnancy). In all cases, the forecastingprocess should take into account expected changes in theprogram coverage or method mix, and compensate forknown shortages in supply.

4.2.5 Nutritional Supplements

4.2.5.1 The quantity of supplements required is determined withreference to the incidence of dietary deficiency, thepopulation of the group to be provided with supplements,(for example pregnant women, children aged less than fiveyears), and the dosage and form of the food supplement.Alternatively, the methods described above underpharmaceuticals can be used.


4.2.6.1 The type of equipment to be procured is determined bythe objectives of the project and the type or level ofhealth-care facility being furnished. For example, aproject that aims to equip or reequip a number of health-care facilities may refer to the standard equipment lists todecide what equipment is appropriate for each site, andthen determine the total quantity of items required byaggregating the requirements of all the sites minus theexisting functioning equipment. Should the project'sobjective be procuring equipment to provide a specificmedical service throughout the health system, then anenumeration of the number of sites providing the servicecompared with the inventory of available equipment atthose sites will make it easier to quantify equipmentneeds .32

4.3 Technical Specifications

4.3.1 Precise and clear specifications are a prerequisite for bidders torespond realistically and completely to the requirements of theemployer without qualifying or conditioning their bids. In the

32 WHO and others have prepared Guidelines for Health Care Equipment Donation, which contain usefulcriteria for identifying appropriate equipment in terms of utility and technical specifications that also applyto procurement.


context of international competitive bidding, the specificationsmust be drafted to permit the widest possible competition and, atthe same time, present a clear statement of the requirements ofhealth sector goods to be provided. No bid may be modifiedafter bid submission, hence the importance of defining accuratetechnical specifications at the onset. Procedures related toamendments of bidding documents and evaluation of bids arespecified in the Standard Bidding Documents and must befollowed.

4.3.2 Pharmaceuticals, Vaccines, Contraceptives, and NutritionalSupplements

4.3.2.1 Most pharmaceuticals and vaccines have some specialfeatures or requirements that should be clearly addressedin the technical specifications that are part of each set of

33Bidding Documents.

4.3.2.2 Several problems must be avoided with the technicalspecifications. They include the following: lack of clarity andspecificity; listing of incorrect or imprecise dosage formns,strengths, and unit pack sizes; failure to define shelf-lifeparameters, and imposing unrealistic delivery schedules. Anyor all may lead to the delivery of substandardpharmaceuticals or vaccines, incorrect dosage forms, orsupply of pharmaceuticals with very limited shelf life. Theconsequences can be substantial wastage and financial losses.An essential key to avoiding these problems is that theborrower should develop specifications that clearly define therequired standards, quality control procedures, packaging anddosage requirements, minimum acceptable shelf life, modeof delivery and realistic delivery schedules. An appropriatelydeveloped and managed national formulary or essential druglist is recommended as the basis for procurement

4.3.2.3 The technical specifications used in contracts forpharmaceuticals, contraceptives, or vaccines assume specialsignificance because of the importance of both qualitystandards and testing procedures. Fortunately, most itemsare included in intemationally accepted pharmacopoeias suchas the British, European, United States or InternationalPharmacopoeias. Bid technical specifications shouldindicate which of the pharmacopoeial standards will beacceptable in the technical specifications, provided theproduct is labeled, formulated, and tested as per the technicalspecifications and according to the section relating to thespecific product in the selected pharmacopoeia. For

33 Further information on specifications for vaccines can be found in Part III - Specifications of Procurementof Vaccines for Public Sector Programs: A Reference Manual (draft).


pharmaceuticals or vaccines not included in any approvedcompendium, but included in the national essential drug list,the manufacturer should be obligated, as part of its bid, toprovide testing protocols and reference standards. Thisshould be clearly stated in the bidding documents and shouldbe incorporated in the General Conditions of Contract (as hasbeen done in the SBDs).

4.3.2.4 Technical specifications need to address issues concerningthe stability of pharmaceutical, vaccine, or contraceptiveproducts, especially under climatic extremes (see annex 3for further details). To ensure safe use, all formulatedproducts are assigned an expiry date beyond which theymay not be potent or safe to use. The period of timebetween manufacture and expiry date is known as theshelf life of the product and is assigned for each individualproduct based on its stability characteristics. Since theperiod of time it takes from manufacture to availability ata dispensing facility can be several months long andtherefore diminish the useful shelf life significantly, thebidding documents should incorporate conditionsstipulating that a certain amount of the specified shelf lifeshould be available on delivery to the purchasing country(see annex 3 for more information).

4.3.2.5 Purchasers need to be aware that many products aredamaged by extremes of temperature. Vaccines inparticular must be transported (and stored) at specifiedtemperatures, and suppliers must be advised of specificrequirements at the bidding stage (see annex 3 for moredetails).

4.3.2.6 It is critical that:

(a) all firms that comply with the technicalspecifications should have the same opportunity infurther evaluation of the bid, and

(b) specifications should not be changed after bidopening-or during evaluation-to suit a particularbidder or justify award to a particular bidder.


4.3.3.1 Competitive procurement of medical equipment shouldbenefit from the use of a standard nomenclature forcommon medical devices that would eliminate variation inthe use of terms (in English) by different countries andthrough translations from other (main) languages. (Forexample, the European Community has adopted theUniversal Medical Device Nomenclature System.)


4.3.3.2 For medical equipment it has been recommended to theBank that a standardized format for specifications beadopted. This would consist of a specifications scope,applicable industry standards and codes, and the salientcharacteristics of the equipment.34

4.4 Procurement Packaging and Scheduling

4.4.1 Pharmaceutical manufacturers generally produce nonsterileproducts (e.g., tablets and capsules), sterile products, or a mixtureof both for a limited group of pharmaceuticals in a particulartherapeutic range. Different manufacturers may elect to preparespecific products in different dosage forms. It is unlikely that asingle manufacturer would be able or willing to bid on thecomplete range of items in a procurement of health sector goodsconsisting of a large number of products. Participation in such aprocurement may thus be limited to merchant exporters, shippers,or general wholesalers. Concems have been raised about theability of these sources to provide adequate guarantees of qualityand to deliver on time because of poor coordination with themanufacturers they represent; a good prequalification process canminimize these hazards. It should be noted that internationalwholesalers such as the International Dispensary Association(IDA) and reputable national wholesalers may provide the onlyreliable bid for small-volume items.

4.4.2 The packaging of pharmaceutical products into smaller sets (lots)for separate bids using therapeutic or product categories isdiscouraged because, except for large-volume infusions,experience has shown that procurement packaging discouragesbidding by reputable manufacturers and limits competition. Sincemanufacturers often specialize in a particular pharmaceutical form,for example, solutions or tablets, packaging could be based onform, and this may improve the opportunity for competition.Overall there is no easy way to group products that can beguaranteed to make evaluating bids easier when the procurementconstitutes many products in different forms. For packaging to beuseful it is essential that the bidder provide a quotation for at leasteighty percent (80%) of the total number of items listed in the lot.Each item offered must comprise the full quantity required for thatitem. A bid that does not comply with this requirement should berejected as nonresponsive.

4.5 Drug Kits

4.5.1 Drug kits-the consolidation of a number of products inpredetermined quantities for specific types of health-carefacility-can be used in "allocation" (or push) distribution systems

34 Medical Equipment Procurement Study, Development Finance International, Inc./ECRI, March 1998.


whereby the central level determnines the quantities to be providedto each service unit. The kits can be assembled either by thesupplier or centrally within the health system. The procurement ofdrug kits requires an individual approach depending on thecountry context. There are four basic options:

* purchase prepackaged kits from overseas;* purchase prepackaged kits on open bid, from local and/or

international suppliers;• contract a local company to pack the kits using drugs

purchased separately through local or international bid;* set up kit packing at national or regional medical stores using

separately purchased products.35

4.5.2 Individual manufacturers of pharmaceuticals, unless theyproduced the majority of the items constituting the kit, are unlikelyto respond to invitations to bid since they would then need to buythe products they did not make. The reduced opportunity forcompetitive procurement may result in higher direct costs. Kitprocurement is usually undertaken by an intermediary agency thatpurchases the kit contents from different sources and thenpackages them according to predetermined specifications.International suppliers add about 3 to 5 percent to the cost of thedrugs to cover their packaging and related activities. Theresponsibility for the quality of the items in the kit rests with thesupplier.

4.6 Scheduling

4.6.1 Given the importance of maximizing the remaining shelf life ofmost health sector goods after delivery, careful attention needs tobe given to the delivery schedules specified in the biddingdocuments. Wherever possible, phased deliveries should beallowed, with the quantity covered by each partial shipmentgeared to the capacity of the logistics system in the country andthe estimated rate of consumption by the user.

35 Taken from Managing Drug Supply, MSH in collaboration with WHO/DAP, 1997.

Annex 1 41

ANNEX 1. Detailed Product Descriptions

Health Sector Product The following is a description of the various categories of health sectorDescriptions goods that are normally included in Bank-financed health projects.

1.1 Pharmaceuticals

1.1.1 Essential Drugs

These are the most common pharmaceuticals used to treat about90 percent of the causes of morbidity in developing countries.Most of them are included on he WHO model essential drug list(which contains almost 400 drugs36) and are listed in acceptedinternational compendia. A number of manufacturers indeveloped and developing countries produce most of these drugsin generic form.

1.1.2 Proprietary Pharmaceuticals

These are newer pharmaceutical products manufactured by oneor only a few companies that either hold the patent ormanufacture under a license from the original patent holder.Most are used at the tertiary level of health care, i.e., inspecialist hospitals, but certain proprietary products may berequired for broader use, depending upon prevailing morbidity,resistance patterns, or superior cost-effectiveness to treatspecific conditions. Some proprietary drugs may be listed innational essential drug lists.

1.1.3 Special Category Pharmaceuticals

This category would include the following:

* Drugs for tropical diseases, pharmaceuticals that areincluded in essential drug lists but are speciallymanufactured by a few companies to combat tropicaldiseases either based on in-house research or under licensefrom WHO. They are seldom used in the country of originbut extensively in poorer countries to control majorepidemic diseases. Pharmaceuticals in this group includethose for schistosomiasis, onchocerciases and antifilarialdrugs, etc.;

* "Orphan" pharmaceuticals, manufactured for certain rarediseases with a very limited market. They are covered bypatents and also receive subsidies to offset research costs.These are produced and distributed mostly in developedcountries;

36 The WHO model list of essential drugs -Tenth List 1997 contains 393 drugs, vaccines, contraceptives, andfood supplements.


* Antiplastic pharmaceuticals for cancer treatment, generallycovered by patents and manufactured in a few developedcountries where consumption of such items is high;

* Specialized pharmaceuticals, used in developing countries atthe tertiary level or in specialized institutions as a second-line treatment. Consumption of such pharmaceuticals isoften small and sporadic in a developing country, primarilybecause of cost;

* Galenicals, out of vogue in industrialized countries but stillcommonly used in developing countries at the primary andsecondary level of health care (i.e., at village dispensariesand subdistrict and district hospitals) for the preparation ofmixtures, emulsions, or ointments. There are very fewinternational manufacturers for galenicals. Normally sold inbulk (one liter plus), they require very heavy freight costsand are not financially attractive for developed countrymanufacturers because of low demand.

1.2 Vaccines

1.2.1 Vaccines to prevent most childhood illnesses are usually named inessential drug lists. Vaccines are in most cases not covered bypatent, but there are few manufacturers in the international market.Most vaccine procurement is either funded by donor agencies orprocured directly through agencies like UNICEF (using their ownprocurement procedures) and supplied to developing countries fortheir immunization programs. Vaccine manufacture involves hightechnology, rigid production protocols, process controls, and strictquality control. Vaccines have a very limited shelf life, and largeproduction volumes are needed for the manufacturer to recovercosts. The international trend is toward consolidation and mergerof the few vaccine manufacturers to enable these companies tomanufacture global requirements economically while still meetingpharmacopoeial or international standards for manufacture andexport. Some developing countries manufacture a limited numberof vaccines for national consumption, but in most cases, thesesources do not yet meet the standards for export.

1.2.2 Vaccines are biological products-being derived from livingorganisms-and thus are different from other pharmaceuticalproducts. They require special quality considerations because ofthe biological nature of the starting materials, the manufacturingprocess, and the test methods needed to characterize batches.

1.2.3 The following are some of the more commonly used vaccineslikely to be procured through Bank loans:

Annex 1 43

(i) Vaccines for Universal Immunization

* BCG;* Diphtheria-pertussis-tetanus;* Hepatitis B;* Measles and measles-mumps-rubella;* Poliomyelitis;* Tetanus and tetanus-diphtheria.

(ii) Vaccines for Specific Groups of High-Risk Individuals

* Influenza;* Meningococcal;* Rabies;* Rubella;* Typhoid;* Yellow fever.

1.3 Contraceptives

1.3.1 Contraceptives take a number of different forms includingpharmaceutical products. Mechanical contraceptives, e.g.,condoms and intrauterine devices (IUDs), are often treated as drugsand regulated by the local regulatory agency for quality control.The WHO essential drug list includes hormonal contraceptives,both pill and injection form, copper-bearing intrauterine devices,and condom and diaphragm barrier methods.

(i) Hormonal Contraceptives

Hormonal contraceptives are pharmaceutical productscontaining synthetic hormones and are available in threemain forms:

* Oral contraceptives (available in a number of doses andformulations);

* Injectable contraceptives (the three primary types aredistinguished by the differing periods of time for whichthey protect against pregnancy as well as formulation ofhormones);

* Implant (only a single type available).

(ii) Intrauterine Devices

The majority of internationally marketed IUDs are plasticmedical devices available in a variety of shapes and sizes.(Metal devices are manufactured in China primarily for theuse in its national program). Plastic IUDs may be enhancedwith copper-bearing or hormone-releasing components.


(iii) Barrier Methods - Mechanical

The majority of mechanical barrier methods are latex orplastic products (male and female condom, diaphragm, andcervical cap).

(iv) Barrier Methods - Spermicides and Microbicides

Spermicidal microbicides barrier methods consist of chemicalagents available in alternative forms (creams and gels, foam,or suppositories).

1.4 Nutritional Supplements

1.4.1 Nutritional supplements are frequently considered for inclusion inBank-financed health and nutrition projects. A range ofpharmaceutical products may be considered as nutritionalsupplements: micronutrients, oral rehydration salts, vitamins, IVsolutions, and minerals. WHO includes a number of such productsin the model essential drug list under the grouping "Vitamins andMinerals" (e.g., Retinol palmitate, riboflavin) and "OralRehydration Salts." These products have conventionally beenclassified as pharmaceuticals, and borrowers should follow similarprocurement procedures as for pharmaceuticals.

1.5 Medical Equipment

1.5.1 The Bank primarily supports the financing of capital goods asopposed to medical consumables. Including a start-up set ofconsumables (e.g., x-ray film, ultrasound gel) should be taken intoconsideration. Further, the local supply and pricing ofconsumables should be checked in parallel with the technicalspecification process. Medical equipment that would generally beclassified as capital goods consists of mechanical, electronic,diagnostic, and life-support products. Medical equipment may becategorized by the level of the facility it is intended to be used atwithin the health system.

The range of available medical equipment is extensive, butguidelines on the type of standard equipment that should be on siteat primary, secondary, and tertiary facilities have been drafted onbehalf of the Bank.37 Project staff may refer to these "standardequipment lists" as the basis for discussion with borrowers on theacceptability of medical equipment for financing with Bank loans.

37 Medical Equipment Procurement Study.

Annex 2 45

ANNEX 2: Guidelines for Prequalification

Why Prequalification?

1. Prequalification is a formal procedure for the screening of potential bidders prior to invitationto bid. Prequalification is not a device intended to reduce competition, but a process to ensure thatinvitations to bid are extended only to those who have adequate capabilities and resources. TheProcurement Guidelines applicable to contracts financed by the World Bank state the requirementsfor prequalification in paragraphs 2.9 and 2.10. This includes an invitation to prequalify that must beadvertised internationally, as described in paragraphs 2.7 and 2.8 of the Procurement Guidelines. Thescope of the contract and a clear statement of the requirements for qualification are sent to those whoresponded to the invitation.

2. A prequalification document should be prepared by the Borrower and approved by the Bankprior to distribution to potential applicants. The Bank has not issued a standard prequalificationdocument for the procurement of health sector goods (pharmaceuticals, vaccines, and condoms.) Forguidance, Borrowers should consult the Bank's Standard Prequalification Document, September1999, which may be adapted using the Guidelines for prequalification attached. The prequalificationdocument should include evaluation criteria and it should be cleared with the Bank before itsissuance.

3. The decision whether to carry out prequalification is a matter that should be agreed on earlyduring project preparation. It should be based on size and value of procurement, the need for timelydelivery, complexity and critical nature of the procurement, etc. Considerations regarding the processof prequalification should weigh the potential benefits against the potential disadvantages, discussedin paragraphs 4 and 5 below.

Benefits of Prequalification

4. The prequalification process may be of benefit to both bidders and borrowers alike, in that:

(a) the process enables prospective bidders, who may be insufficiently qualified on theirown, to avoid the expense of bidding, or to form a joint venture that may give a betterchance of success;

(b) with prequalification, well-qualified firms will price their bids with the knowledgethat they are competing against other similarly qualified bidders;

(c) prequalification enables borrowers to assess the interest from qualified firmsgenerated by the contract and, in the event that no applications, or only a limitednumber of applications, are received to make any necessary adjustments in theprocurement requirements, conditions, or terms;

(d) it reduces the amount of work and time involved by purchasers in evaluating bidsfrom unqualified suppliers; and

(e) it significantly reduces, if not eliminates, problems associated with low-priced bidssubmitted by bidders of doubtful capability.


Disadvantages of Prequalification

5. On the negative side, prequalification has some potential disadvantages:

(a) unless an early start of the procurement process is made, the delivery target for thegoods may not be met;

(b) the borrower is required to review all prequalification applications, whereaspostqualification requires the review of the qualifications of only one (the lowestevaluated) or a few bidder(s);

(c) collusion (and the possibility of price-rigging) is easier among a small number ofidentified bidders.

6. The Bank, from its own experience, has found that the benefits of prequalification undertransparent conditions outweigh by a considerable margin the potential disadvantages, for bothborrowers and the bidding community alike.

Annex 2 47

Qualification Criteria

Required average annual turnover[The amount of Annual Sales Value required should be at least five times the estimated contract

value.]

Required production capacity[The Annual Production required should be at least three times the quantities specified under the

contract.]

Required number of similar contracts completed[The range should be not less than three and not more than five (normally four), depending on the size

and complexity of the subject contract within the lastfive years.]

Required Quality Assurance[In the case of an applicant who manufactures the goods, the applicant should provide (i) a valid

license issued by the regulatory authority in the country of manufacture to supply the goods and (ii)

evidence that it has received a satisfactory GMP inspection certificate in line with the WHO

certifcation scheme on pharmaceuticals moving in International Commerce from the regulatory

authority in the country of manufacture of the goods or has been certified by the competent authority

of a member country of the Pharmaceuticals Inspection Convention, and has demonstrated

compliance with the quality standards during the past two years.

In the case of an applicant who does not manufacture the goods, the applicant should provideevidence of being duly authorized by the manufacturer, meeting the criteria under (i) and (ii) above, to

supply the goods.]

Required number of years of manufacturing experience[The applicant should have manufactured and marketed the specific goods subject of bidding for atleast two years, and for similar goods for at least five years. Applicants wishing to prequalify for

products that they do not manufacture must submit the information corresponding to the primary

manufacturer of the goods who shall comply with these manufacturing requirements.]

Required experience on packaging, distribution, and transportation[The applicant should provide proof of experience with and knowledge of modes of packing,

distribution, and transportation of pharmaceuticals, vaccines, and condoms under logistical andclimatic conditions similar to the ones in the purchaser's country. It should provide names of

countries to which the firm has supplied (including packaged, distributed, and transported) products

worth at least US$50, 000 within the past three years.]

48 Technical Note for the Procurement of Healti Sector Goods

Guidelines for PrequalificationAll information provided should be relevant to the specific procurement

Section 1: Company Details and General Information

1. Name of Firmn:............ ............ ..... ..... ..I ....... .. .............. .............. . ................. t ........... ......... ,.. .... ....... ... .. . ........... .... .. -...... _

2 Street Address: Postal Code: City: Country

. .......-.. ..... .......... ... ..... .. ... ..- .- - ..... .. ..... .... ... . . .............. ... .......................-...

3. P.O. Box and Mailing Address:...... ...... ... ........ .. . ..... ........ .. .... . .....I......... ..... ..... ..... ... ........ .... ... ........... .... ..... ..... .. . ..... .. ............ .. ........ ......... ... ................ .... ..... ..... -- -----. ........ .............

4. Telephone Number:

5. Fax Number:

6. E-mail Address:.............. .. ...... .. ..... .. ... .......... .... ................ .. .. .,..... .. .... ................ ...... ......_

7. WWW Address:....... ................... .. ......... . ... ......... . ... .............. . .. ........ ........ ........ . ....... . ............................. .................... . .... . ... . ... ....................

8a. Contact Name:

8b. Contact Title:

9. Parent Company, if Any (FullLegal Name):

10. Subsidiaries, Associates, and/or Overseas Representative(s), if Any:

I 1. Nationality of the Firm...... ..... ...... ........ .. ..... ........... . . ..... .................. .............. ............ . .... .............. ....... ............. ...... .......... ......... .............. ........ . .. ........ ...... ..... ..... ..... .. ..._

12. Type of Business:

12a. If Other, specify:

13. Nature of Business:.. ............ .................................. ........... ........... ............. ....... ................ ..................... ... ..... ...... .... ........................ .... . ............................. .... . ...................... ......

14. Year Established:

15. Key Personnel: [include name of candidate, position, professional qualifications, and experience]

Technical Production Management-..... .................. ... . ...... ......... .. ........... .. ........ . ....................... ......... ._ .............. ...... .... ........ ...... ...... . ..... . ... . ....

16. Dates, Numbers, and Expiration Dates of Current Licenses and Per nits:

I. ......... ........... . ...--.. .... ........... -.......... ....... ... ..... ........ .. ...... ......... ... ..... - . . ... ......... .... . ... . . .......... . . . ......................

17. Current health authority registration information:

........... ............ ..... ...... . ..........-............ . ................ ... .......... .. ............ . ..... .................... .................... .......... ..... .... ... b . ......... . ... ... _..... ...... ...... . .. - - -_---

18. Proof of product and facility registrations with purchaser's country regulatory authority andinternational agencies (e.g., WHO Certification Scheme, GMP)

Annex 2 49

19. Name of government agency(ies) responsible for inspecting and licensing of facilities in thecountry of origin of the raw material and or processing of the goods:

Date of last inspection:.......... 1 1............ ...I ....... ....... ............... ..... I ............I.............. ..... ..................... ................ .............. ..................... ...................... ...... ... ................. .......... ........

20. Quality Assurance Certification(Please include a copy of your latest certificate withthe PQ application):

............ . .......... ... .. - - ........ ... ................ ....... .............. ........ .. .......... ..... ........ .. ........ ........ ....... . .... ........ ....... . .... ..... .....

21. Production capacity: [insert peak and average production capacity over the last three years inunits/day or units/month, etc.]

22. List of names and addresses of sources of raw material:

.... ... ... ...... .........-.1 ..................... --------.. ................ ........... ....... .....- -.. ...... .. ......... . .. ... ..... . ........... ... - - - -- - - - -................

23. Raw materials tested prior to use:

..... ...... .I I. .................. ......... ............ ............. ...... ......... - .. ...... . ..... ............................... . ...-............. . . ... ...

24. Presence and characteristics of in-house quality control laboratory

25. Names and addresses of external quality control laboratories used:

.... ...... ....... - .-............ I ........... ... o. .......... .............. _- ..... _.. ......... . ... _......__

26. Are all finished products tested and released by quality control prior to release for sale?

DYes O No If not, why?..... .. ..... ... ......... ........ ...... ...... ... ..- .... . .......... ..... ............. . ...... .... ...... . ... . ....._._ .. ..... ____._.__._

27. List control tests done during production? If so list.

. ............... .-. ...... .......I .............. ........... -....... ... ............ . .. -... _. .. . .. .... ...... _ _.

28. Procedures for dealing with rejected batches:

... ....... . .....I .I.-. ........ ...... ...... . ...I.. ............... . ... ... ...- -. ............ ............. .............-..-...................... . .... ....... ............ . ...... .. . .. ...... ....

29. List tests conducted after production and prior to release of product on market:

I.. ............ ................... .......... . .......... ..... ............. .. . ......... - -..... . ... ........... .--.... . .................. . ........ .. ......... ... . ... ....... .. .. .. ....... ..................

30. List product recalls linked to defects during the last 36 months. Include reason and date of recall.

-................ .I I ........ ............ . ......... .... . .......... ...... . .-. ...... ............. ............. ....... ........................-. . ... . -- - - - --

31. Are technical documents available in: [Purchaser should insert language]

Lyes Eno

32..W rknu.... .... L....a.................a...... ................... ........... ..................._ ...... .................... ...........o.c.. _ _e. .d i.t.w.32. Working languages (Language of bid and contract): [Purchaser should insert working language]


Section 2: Financial Information

33/34. Annual Sales Value for the last 3 years:

Year Total Sales (USD)......... .. .......... .... .. ....... ...... ....... ..... ... .......... .........- ........... ............. .. ...... ............ . .. .......... ............ . . .............. .. ...... .. ............. . .... . .......... ............ ............ . .. ........ ..... ........ ....... ... ... ......... .. .............

............ ............ ..... ........... ........ . .......... ... .. ............. . .... ......... ... . ................. ....... ........... .. ......... ....... ........ .... .. ......... .... .......... ........ . ....... ..... .......... .... ....... ... ......... . ... .

..... ....... . ...... ... ............. ..........-.......... ...... ..... .......... .... ... .............. ......... ............. .... .... . ........... . .......... ....-......... ...... . ....... . ......................... ........ ... .. ... . ...... . ....... .... .. . . .. .... .... ............. .. .....

........ .................................................... ...... ............ .......... .- ............... ............... ................................... . .. ........... ..... ....................... .. ..... ...... . ................ ................. .............

35. VAT No./Tax I.D.:.. ........ ......... ......... .. ........ ............... ..... ..... ................ ......... . ....... ..... ....... .... ..... ... ... ........... ......... .. ......... . .......... ....... . ......... ........... ........................................ .........................................

36a. Bank Name:

36b. Swift/BIC Address:

36c. Bank Address:

36a. Bank Account Number:. ..........- ............ ......... ..................... ....... .... .. ..... ............. ....-........ ..................... ........... ............ ...................... ........... ................ ............................. .......... ........................ ..... ........................

36b. Account Name:.. ........I.... ........ ....................... . ....... ..... ... .............. ......... .. ............. ......... . ... .........-.1-................ ...-.... ............. .. .......... .. .... ............ .. ................... ...................................... ..........................

37. Please mail a copy of the company's Annual or Audited Financial Report of the last three years.

Section 3: Current Contract Commitments / Contracts in Progress

38. Name of Contract(s)

........ ........ ...... . ... .. ......... .......... ............................................ . . .......... .... ........ ....... ....... ... . ......... ... .. . .............. ...... . ... . .............. ....... ......... .................. ................ ...................... . ....-...... ...........

39 Purchaser Contact Information [insert address, telephone, fax, e-mail address]

~~~~~~~~~~~~~~~~~~~~~................... ... .. ........ , ... ... ......... .... J....... ...............I.......... ..... ..... .... ........... ... ............. ... ........ ........ ...- .......... . ... .... ............

40 Value of outstanding contracts [current US$ equivalent]

......... .......................... ............ ... ..... .. ...........I......... I -........... ............ .. ... ....I............... . ......................... .. ............... ........ ..... ... .. . ..... . ....... ... ............... ........ ..... . ...... ....

41 Estimated delivery date

..................... ..... ... .... I - .... ...... - . I - ...........I............ ........................................... .... I.......... ........... ................ ..... .I.... ...... ...... ..... ............ ........................ ...........

42 Average monthly invoices over the last six months (US$/mon.)

Section 4. Experience

43. Contracts over [insert amount] during the last three years:....... .. ............ . ........ ............ .............. ............................... ............. .......... ..... ......... . ........... ............ ............ . .......... ..... ........ .. ...... . ................... .......................- -..................

Purchaser Value Year Goods/Services Supplied Country ofDestination

Annex 2 51

Section 5: Other

44. Please list any disputes your company has been involved in over the last 3 years:Year Award FOR . Name of client, cause of litigation, and Dispute amount

or AGAINST matter in dispute (current value, US$applicant equivalent

.... ....... ... .... ....... .... ......... ... .. ...... .. ......... ..... ....... ........ .. ........ ....... ...... . .. ....... ... .. ..... .. ... ...... . ........ .. ..... .... .. .............. ...... ..... .. .................. ....................

............... ....... ....................................... ....... .... ....... . . I I...................... . ....... . ........ . ......... ..-......... .......... I II . ...........-... ... .................. 1 1 I -. I - - - ..... .- 1

45. We hereby certify that the information provided in this forrn is correct, and in the event ofchanges, details will be provided as soon as possible.

Signed:

Date:

in the capacity of: [insert title or other appropriate designation]

Annex 3 53

ANNEX 3. Miscellaneous Considerations

Miscellaneous 1. I Stability and Shelf LifeConsiderations

1.1.1 Pharmaceuticals, vaccines, and contraceptive products areconsidered stable if they retain the physical, chemical,microbiological, therapeutic, and toxicological characteristicsrequired in the technical specifications for a designated period,which is termed "shelf life" (see below). A warranty to this effectshould be required from the manufacturer. Stability is affected byadverse conditions during storage and transit. Deterioration mayresult in a change in chemical, physical, or antibacterial propertiesof the medicine. Deterioration of certain products may at timesdegrade the drug's therapeutic value or increase its toxicity.Deterioration tends to accelerate under hot and humid conditionsin most tropical countries.38 Common essential pharmaceuticals,vaccines, and contraceptives withstand tropical conditions fairlywell. The implementing agency should clearly specify in thebidding documents any extreme environmental conditions existingin the area of final delivery and use that must be considered bypotential bidders.

1.1.2 Studies conducted by the manufacturer on stability should bemade available to the borrower on demand duly verified by theFDRA of the bidder's country. For tropical climates, based onsimulated conditions and stability evaluation, shelf life would haveto be suitably adjusted.

1.1.2.1 Shelf life varies for different product groups and dosageforms. Most commonly used pharmaceuticals andcontraceptives have a shelf life of three to five years fromthe date of manufacture. Certain products in liquid forms,vaccines, sera, venom, etc., have a shorter shelf life,sometime only twelve months or less. To ensuremaximum shelf life is made available to the borrower onarrival in the country, the following standard conditionshould be incorporated in all bidding documents:pharmaceuticals and vaccines should have, as a minimum,three-fourths of the specified shelf life remaining onarrival at the port of entry. (See footnote 16.)

1.1.2.2 Printing of the date of manufacture and date of expiry onthe label of the primary container and the outer package ismandatory in most countries. It should be clearlystipulated in the technical specifications that failure to

38 The following commonly used drugs have been found to have stability problems under tropical conditions:Acetylsalicylic acid, Amoxicillin, Ampicillin, Penicillin V, Retinal (tablets); Paracetamol (syrup);Ergometrine, and Methylergometrine (injections).


print a description of the contents, the date ofmanufacture, and the date of expiry on the primarycontainer and the outer package may result in rejection ofthe products upon inspection.

1.1.2.3 Certain products tend to lose potency faster during theirshelf life. To compensate for such losses, manufacturersare allowed to add additional quantities of activeingredients termed as "overages," to ensure that the statedpower of the active ingredient is available for therapeuticefficiency during the shelf life of the item. According tointernational standards, overages of up to 30 percent aregenerally acceptable. However, overages above thepermissible limit result in administration of a higher dosewithout a physician's knowledge or supervision andtherefore can be hazardous to the health of the patient.The technical specifications should clearly specify that allpharmaceuticals and vaccines will conform to compendiastandards for overages and that items with overages abovethe permissible ceiling will not be accepted.

1.2 Samples

1.2.1 Purchasers requiring submission of samples along with thebids should be discouraged. Normally no samples should berequested, and decisions on award should be made based onmerit of the bid and bidding qualifications. In exceptionalcases when submission of samples is justified, because ofhigh risks and quality assurance reasons, the biddingdocuments (BDS) should identify this requirement byrequiring the successful bidder to provide samples for testsbefore award, allowing a reasonable time for suchsubmission. However, the procedures and details of tests tobe conducted should be specified and results of tests obtainedwithin a reasonable time of about two weeks. For such items,bidders should be required to submit, along with their bids,test results conducted in a recognized laboratory. If thesamples fail, pursuant to tests conducted by the purchaser,bidders will be notified of the discrepancies and items offailure accompanied with test reports submitted by the bidder.

1.3 Special Storage and Transportation Conditions

1.3.1 Most commonly used pharmaceuticals made in the form of tablets,capsules, syrups, and emulsions are stable, if protected from lightand direct heat and stored in a well-ventilated place attemperatures below 300 centigrade. However, some items requirevery special storage and transportation to ensure stability. Thefollowing are the differing storage and transportation conditionsrequired for most pharmaceuticals and vaccines according to theofficial compendia. Protection from excessive humidity is also

Annex 3 55

important for most items, although these standards for temperatureand humidity may be difficult to achieve in some developingcountries.

(a) Common pharmaceuticals (e.g., tablets, capsules, granules,syrups, and emulsions): Store in a cool dry place below 300centigrade. Can withstand transit hazards for short periods.

(b) Injectables, antibiotics, ophthalmic items, certain syrups,and sterile ointments: Store in a cool room at a temperatureof between 150 and .250 centigrade or below. Deliver inspecial containerized vehicles.

(c) Most vaccines, sera, immunebiologicals: Store at below 2-80 centigrade. Ship in cold boxes or as cold chamber cargo.

(d) Polio and measles vaccines, some toxoids: Store at below-4° centigrade in freezers. Ship only in freeze chambers andtransport in refrigerated carriers.

1.3.2 Individual monographs on pharmaceuticals and vaccines in theofficial pharmacopoeias specify the correct storage and transitconditions for each pharmaceutical or vaccine. When productsrequire special handling during transit, these transportationrequirements must be specified in the bidding documents. Forvaccines, sera, etc., the purchaser must specify that vaccines are"To Be Air-Shipped as Cold Chamber Cargo." The suppliershould also be required to alert the borrower to release theshipment immediately upon arrival and arrange for transport inrefrigerated carriers or cold boxes. Similarly, for containertransport, suppliers should be advised not to ship in dark paintedcontainers and that storage arrangements during marine transitshould avoid the deck and boiler house areas of the vessel used.

1.4 Product and Product Packaging Specifications

1.4.1 All products should be described in the technical specificationsand labeled by their international nonproprietary names (INN) orgeneric names. Each product's name should also appearprominently on the label in addition to any trademark or brandname.

(a) Product Specifications: This should indicate (i) dosage form(e.g., tablets, capsules, injection, dry syrup, liquid, ointmentemulsion, suspension, etc.) and (ii) content per tablet,capsule, or milliliter or gram on the basis of weight byvolume (WN) or volume by volume (VAV). Mostpharmacopoeias indicate the product specification andacceptable range. For pharmaceuticals or vaccines notincluded in a compendium, the borrower should clearlyindicate acceptable limits.


(b) Product Packaging. Most official pharmacopoeias establishthe following broad guidelines for primary containers. Theprimary containers should maintain quality, safety, andstability of the pharnaceutical or vaccine contained.Primary containers should be able to withstand themechanical hazards of handling and transport, preventleakage and environmental degradation, and have nophysical or chemical effect on the contents. For liquids, thecontainers should be sufficiently transparent for visualinspection and should be covered with outer packaging toprotect the contents from incidental radiation. Packagingmaterials that can satisfy all the above conditions fully areoften not available locally in developing countries.

(c) Generally the following are considered the most suitablematerial for different dosage forms:

(i) Glass: Neutral glass containers, colored whenrequired for light-sensitive pharmaceuticals to resistultraviolet radiation, are the most suitable for liquidpreparations. Glass offers a very distinct advantage inthat it can be sterilized, but it is heavy and thereforeexpensive to transport.

(ii) Plastic Containers: These have traditionally beenavoided for liquids except for some very stableproducts that are consumed over a very short period.When stored longer, leaching of the plasticizersoccurred and in some cases may have caused chemicalinteraction with the pharmaceutical or vaccinecontent. Plastic containers with an inner coating canbe used for nonhygroscopic items, tablets, andcapsules, and new-generation plastic containers arebecoming available that are approved for use withliquids. Borrowers should specify in the biddingdocuments the type of plastic that can be used forcontainers in compliance with pharmacopoeialstandards.

(iii) Metal Containers: These are suitable for large packsof tablets and capsules and should preferably belacquered from the inside and have an inner polymerlining for added protection.

(iv) Films and Laminates: A combination of plastic,aluminum, and paper is ideal for single-dose packs.Unit packing in such laminates increases the costconsiderably and thus cannot replace bulk packing inmost routine cases. In-house unit packs at the hospitallevel for the amounts needed for weekly consumptioncould be a much cheaper option in developingcountries.

Annex 3 57

(v) Containers for External Preparations: The shape andsize of product containers for external use should bedifferent from containers for systemic use products toprevent accidental ingestion. Usually externalpreparations (e.g., ointments and creams) are packedin (i) jars; (ii) aluminum extrusion tubes for smallquantities of ointments, or (iii) fluted glass bottles forliquids. For products not included in any officialcompendium, the borrower must clearly stipulate thetype of immediate container to be used.

1.4.2 In general, all containers should be filled to the top, and in case ofdry products, the residual space should be filled with bubbleplastic or other suitable material and then sealed. For liquids, thebottles should be closed with screw caps with inert lining toprovide a moisture-proof seal. All packaging components mustmeet compendial standards and be approved for pharmaceuticalpackaging by the manufacturer's national FDRA. The externalcontainers should be export-worthy and suitable to withstandrough handling in transit and during storage.

1.5 Labeling

1.5.1 As detailed in part B of the technical specifications of the SBD,the product should be labeled according to the applicablepharmacopoeial standard.

General Guidelines for Labeling

= The language for labeling should be clearly stated in thecontract.

* All package labels should contain at least the followinginformation:

- Generic name (INN) of the active ingredients;- Dosage form (tablet, ampoule, vial);- Quantity of active ingredient(s) in the dosage form;- Number of units per package;- Batch number- Date of manufacture;- Expiry date (in clear language, not code);- Pharmacopoeial standard;- Instruction for storage;- Name and address of manufacturer;- Name and address of distributor, if not supplied by the

manufacturer directly;- Desired cautionary statements.

* Directions for use and precautions may be given in leaflets(package inserts), though these provide supplementaryinformation and are not an alternative to labeling.


1.5.2 Similar information should appear on exterior cartons.

1.6 Inspection and Testing

1.6.1 Most ICB contracts for pharmaceuticals and vaccines are on a CIFor CIP basis and require a visual preshipment inspectionconfirming that the quantity and packing method used appear to besatisfactory. Pharmaceutical and vaccine quality is accepted onthe basis of quality test certificates provided by manufacturers.However, to reinforce quality assurance, inspection agents shouldbe periodically asked to collect samples from lots ready forshipment for independent testing. The bidding documents shouldmake it clear that these will be corrected only at the purchaser'scost. (If the supplier or manufacturer pays for these tests, there isa risk that the results will not be impartial.) Shipment should notbe authorized until the test results are evaluated and certified bythe borrower. This condition as well as the borrower's right toconduct random tests at the successful bidder's cost should beincorporated in the General Conditions of Contract as has beendone in the "Inspections and Tests" subclause in the SBD.

Annex 4 59

ANNEX 4. Model Certificate of a Pharmaceutical Product

Certificate of a Pharmaceutical Product1

This certificate conformns to the format recommended by the World Health Organization (generalinstructions and explanatory notes attached).

No. of certificate: _____________________________________

Exporting (certifying) country: ___________________________

Importing (requesting) country: ____________________________

1. Name and dosage form of product:

1.1 Active ingredients and amount(s) per unit dose.3

For complete qualitative composition including excipients, see attached.4

1.2 Is this product licensed to be placed on the market for use in the exporting country? 5 yes/no(key in as appropriate)

1.3 Is this product actually on the market in the exporting country? yes/no/unknown (key in asappropriate)

If the answer to 1.2 is yes, continue with section 2A and omit section 2B.

If the answer to 1.2 is no, omit section 2A and continue with section 2B.6

2A. I Number of product license 7 and date of issue:

2A.2 Product-license holder (name and address):

2A.3 Status of product-license holder:' alb/c (key in appropriate category as defined in note 8)

2A.3.1 For categories b and c the name and address of the manufacturer producing the dosage form9are:

2A.4 Is Summary Basis of Approval appended?10 yes/no (key in as appropriate)

2A.5 Is the attached, officially approved product information completeand consonant with the licence?' 1 yes/no/not provided(key in as appropriate)


2A.6 Applicant for certificate, if different from license holder (name and address):'2

2B. I Applicant for certificate (name and address):

2B.2 Status of applicant: a/b/c (key in appropriate category as defined in note 8)

2B.2. 1 For categories b and c the name and address of the manufacturer producing the dosage form9are:

2B1.3 Why is marketing authorization lacking?

not required/not requested/under consideration/refused (key in as appropriate)

2B.4 Remarks: 13

3. Does the certifying authority arrange for periodic inspection of the manufacturing plant in whichthe dosage form is produced?


If no or not applicable, proceed to question 4.

3.1 Periodicity of routine inspections (years):

3.2 Has the manufacture of this type of dosage form been inspected?yes/no (key in as appropriate)

3.3 Do the facilities and operations conform to GMP as recommended by the World HealthOrganization?'5


4. Does the information submitted by the applicant satisfy the certifying authority on all aspectsof the manufacture of the product? 16


If no, explain:

Address of certifying authority:

Telephone number: Fax number:

Name of authorized person:

Annex 4 61

Signature:

Stamp and date:

General instructions

Please refer to the guidelines for full instructions on how to complete this form and information onthe implementation of the scheme.

The forms are suitable for generation by computer. They should always be submitted as hard copy,with responses printed in type rather than handwritten.

Additional sheets should be appended, as necessary, to accommodate remarks and explanations.

Explanatory notes

i This certificate, which is in the format recommended by WHO, establishes the status of the pharmaceutical product andof the applicant for the certificate in the exporting country. It is for a single product only since manufacturingarrangements and approved information for different dosage forms and different strengths can vary.

2 Use, whenever possible, intemational nonproprietary names (INNs) or national nonproprietary names.

3 The formula (complete composition) of the dosage form should be given on the certificate or be appended.

4 Details of quantitative composition are preferred, but their provision is subject to the agreement of the product-licenseholder.

5 When applicable, append details of any restriction applied to the sale, distribution, or administration of the product thatis specified in the product license.

6 Sections 2A and 2B are mutually exclusive.

7 Indicate, when applicable, if the license is provisional or if the product has not yet been approved.

s Specify whether the person responsible for placing the product on the market:

(a) manufactures the dosage form;(b) packages and/or labels a dosage form manufactured by an independent company; or(c) is involved in none of the above.

9 This inforrnation can be provided only with the consent of the product-license holder or, in the case of nonregisteredproducts, the applicant. Noncompletion of this section indicates that the party concerned has not agreed to inclusion ofthis information.

It should be noted that information concerning the site of production is part of the product license. If the production siteis changed, the license must be updated or it will cease to be valid.

0 This refers to the document, prepared by some national regulatory authorities, that summarizes the technical basis onwhich the product has been licensed.

l This refers to product information approved by the competent national regulatory authority, such as a summary ofproduct characteristics (SPC).


12 In this circumstance, permission for issuing the certificate is required from the product-license holder This permissionmust be provided to the authority by the applicant.

13 Please indicate the reason that the applicant has provided for not requesting registration:

(a) the product has been developed exclusively for the treatment of conditions-particularly tropicaldiseases-not endemic in the country of export;

(b) the product has been reformulated with a view to improving its stability under tropical conditions;(c) the product has been reformulated to exclude excipients not approved for use in pharmaceutical products

in the country of import;(d) the product has been reformulated to meet a different maximum dosage limit for an active ingredient;(e) any other reason, please specify.

14 Not applicable means that the manufacture is taking place in a country other than that issuing the product certificateand inspection is conducted under the aegis of the country of manufacture.

1 5 The requirements for good practices in the manufacture and quality control of drugs referred to in the certificate arethose included in the thirty-second report of the Expert Committee on Specifications for Pharmaceutical Preparations(WHO Technical Report Series, No. 823, 1992, annex 1). Recommendations specifically applicable to biologicalproducts have been formulated by the WHO Expert Committee on Biological Standardization (WHO Technical ReportSeries, No. 822, 1992, annex 1).

16 This section is to be completed when the product-license holder or applicant conforms to status (b) or (c) as describedin note 7 above. It is of particular importance when foreign contractors are involved in the manufacture of the product.In these circumstances, the applicant should supply the certifying authority with information to identify the contractingparties responsible for each stage of manufacture of the finished dosage form, and the extent and nature of any controlsexercised over each of these parties.

The layout for this model certificate is available on diskette in WordPerfect from the Division of Drug Management andPolicies, World Health Organization, 1211 Geneva 27, Switzerland.


ABBREVIATIONS

AIDS Acquired Immune Deficiency SyndromeCIF Cost, insurance, freightCIP Cost, carriage, and insurance paidECHO Equipment for Charitable Hospitals OverseasEDL Essential Drug ListEPI Expanded Programs on ImmunizationFDRA Food and Drug Regulatory Agency/AuthorityGMP Good Manufacturing PracticesHNP Health, Nutrition, and PopulationICB International Competitive BiddingIDA International Dispensary AssociationINN International Nonproprietary NameIUD Intrauterine DeviceIFB Invitation for BidLIB Limited International BiddingMA Marketing AuthorizationMCH Maternal and Child HealthMIS Management Information SystemMSH Management Sciences for HealthNCB National Competitive BiddingNGO Nongovernmental OrganizationOC Oral ContraceptiveSBD Standard Bidding DocumentsTN Technical NoteTTL Task Team LeaderUN United NationsUNICEF United Nations Children's FundUNFPA United Nations Population FundUSD United States DispensaryWHO World Health Organization


GLOSSARY

Bid security A form of financial guarantee provided by the bidder when a bid is submittedand forfeited if a bidder withdraws the offer during the period of bid validity,refuses to sign the final contract, or does not provide the required performancesecurity. The bid security remains valid for four weeks after the date of validityof the bids. Bid security is returned to unsuccessful bidders.

Eligible source countries Bank member countries.Estimated quantity supply A contract for a fixed period that indicates an estimated total quantity. Thecontract actual total quantity purchased is determined by orders placed during the

contract period as required.Good manufacturing Good manufacturing practice is that part of quality assurance that ensures thatpractices (GMP) the products are consistently produced and controlled to the quality standards

appropriate to their intended use and as required by the marketing authorization.Marketing authorization A legal document issued by the competent drug regulatory authority that

establishes the detailed composition and formulation of the product and thepharmacopoeial or other recognized specifications of its ingredients and of thefinal product itself, and includes details of packaging, labeling, and shelf life.

Pharmaceutical product Any medicine intended for human use presented in its finished dosage form oras a starting material for use in such a dosage form, subject to control bypharmaceutical legislation in both the exporting state and the importing state.

Prepacked kits An assortment of drugs (and medical supplies) to cover a set number of patientattendances, which are distributed unopened to health facilities.

Prequalification An assessment made by the purchaser before inviting bids of the experience andcapacity of suppliers expressing interest in undertaking a particular contract.

Postqualification An assessment made by the purchaser immediately prior to award of contract, toensure that the lowest-evaluated, responsive, eligible bidder is qualified toperform the contract in accordance with the qualification requirements.

Shelf life The length of time that a product may be stored without affecting its usability,safety, purity, or potency.

Stability Pharmaceuticals, vaccines, and contraceptive products are considered stable ifthey retain the physical, chemical, microbiological, therapeutic, andtoxicological characteristics required in the technical specifications for adesignated period.

Standard Treatment Systematically developed statements that assist prescribers in deciding uponGuidelines appropriate treatments for specific clinical problems; they reflect a consensus on

the optimal treatment to use at a health facility or hospital.Supplier Primary manufacturer of a health sector good or an individual/organization with

authority to act as an agent for the primary manufacturer.Vaccine Independence A program implemented by UNICEF that enables client governments toInitiative reimburse UNICEF for vaccine procurements in the local currency of the

country (subject to certain conditions).


REFERENCE LIST

Development Finance International, Inc./ECRI. "Medical Equipment Procurement Study." March1998.

Dreyfuss, Michele L., and Rebecca J. Stoltzfus. Guidelines for the Use of Iron Supplements toPrevent and Treat Iron Deficiency Anemia. Washington, D.C.: ILSI Press, 1998.

Management Sciences for Health (MSH) in collaboration with the World Health Organization, ActionProgramme on Essential Drugs (WHO/DAP): Managing Drug Supply, Second Edition. Edited by J.D. Quick, J. Rankin, R. O'Connor, H. V. Hogerzeil, M. N. G. Dukes, and A. Garnet. Hartford,Connecticut: Kumarian Press, 1997.

Management Sciences for Health/Rational Pharmaceutical Management Project (MSH/RPM). RapidPharmaceutical Management Assessment-An Indicator-based Approach. Arlington, Virginia:Management Sciences for Health, July 1995.

MSH. The International Drug Price Indicator Guide. Boston, Massachusetts: Management Sciencesfor Health, 1997 (Updated annually).

PATH. Contraceptive Manufacturing Overview Draft Paper (No. 10) prepared for the World Bank.Seattle, Washington. (NB. Date and reference being checked).

The World Bank. Guidelines Procurement under IBRD Loans and IDA Credits Fifth Edition, Revisedand Expanded. Washington, D.C.: The World Bank, 1995.

The World Bank. Guidelines Selection and Employment of Consultants by World Bank Borrowers.Washington, D.C.: The World Bank, 1997.

World Health Organization (WHO). "Annex 1: Good Manufacturing Practices for PharmaceuticalProducts." WHO Expert Committee on Specifications for Pharmaceutical Preparations: Thirty-second Report. Geneva, Switzerland: WHO, 1992.

WHO. Guidelines for National Authorities on Quality Assurance for Biological Products. Geneva,Switzerland: WHO, 1992.

WHO. "Annex 12: Guidelines on Import Procedures for Pharmaceutical Products." WHO ExpertCommittee on Specifications for Pharmaceutical Preparations: Thirty-fourth Report. Geneva,Switzerland: WHO, 1994.

WHO. "Indicators for Monitoring National Drug Policies." Geneva, Switzerland: WHO/DAP, 1994.

WHO. "Annex 8: National Drug Regulatory Legislation Guiding Principles for Small DrugRegulatory Authorities." WHO Expert Committee on Specifications for PharmaceuticalPreparations: Thirty-fifth Report. Geneva, Switzerland: WHO, 1995.

WHO. "WHO Certification Scheme on the Quality of Pharmaceutical Products Moving inInternational Commerce." Geneva, Switzerland: WHO, 1997.

WHO et al. "Guidelines for Health Care Equipment Donations (Fourth Draft)", 1997.


WHO. "Essential Drugs: WHO Model List (revised in December 1997)." WHO Drug Information,Vol. 12, No. 1 (1998).

WHO/GPV. Procurement of Vaccines for Public-Sector Programs: A Reference Manual, Vol. I & 2Geneva, Switzerland: WHO, 1998.

WHO/UNICEF/IVACG Task Force. Vitamin A Supplements: A Guide to Their Use in the Treatmentand Prevention of Vitamin A Deficiency and Xerophthalmia, Second Edition. Geneva, Switzerland:WHO, 1997.


USEFUL CONTACT INFORMATION

UN Agencies

UNICEFCustomer Services and Support Centre or Contracting CentreUNICEF Supply DivisionUNICEF Plads - FreeportDK-2100 Copenhagen 0DENMARK

Telephone: (35) 273527; fax: (35) 269421; telex: 19813E-mail: [email protected]

UNFPASenior Procurement OfficerProcurement UnitUnited Nations Population Fund220 East 42nd StreetNew York, NY 10017USA

Telephone: (212) 297 5384/5392, fax: (212) 297 4916/5250E-mail: saunders(unfpa.org

WHOProcurement DivisionWHO20 Avenue AppiaCH-1211 Geneva 27SWITZERLAND

Sources of Price Comparison Information

The International Drug Price Indicator Guide. Management Sciences for Health, Drug ManagementProgram, 1515 Wilson Boulevard, Suite 720, Arlington, VA 22209, USA (Tel: 703-524-6575; fax:703-524-7898; e-mail: [email protected]; WWW URL: http://www.msh.org)

UNFPA Procurement Unit (see above)

UNICEF Supply Division (see above)

Global Programme for Vaccines and ImmunizationWHOTel: 41 22 791 4788/4471Facsimile: 41 22 791 4384GVP Internet: [email protected] address: [email protected]

International Committee of the Red Cross19 Avenue de la PaixCH- 1202 Geneva, SwitzerlandTel: 41 22 734 60 01


Fax: 41 22 733 20 57Tlx: 414 226 CCR CH

International Federation of Red Cross and Red Crescent Society17, ch. Des Crets/Pt- SaconnexP.O. Box 372, 1211 Geneva 19, SwitzerlandTel: 41 22 730 4222Fax: 41 22 733 0395Tlx: 412 133 FRC CH

Medecins Sans Frontieres International Technical CoordinationRue de la Tourelle, 39Bruxelles 1040 Brussels, BelgiumTel: 32 2 474 75 62/63Fax: 32 2 474 74 68Tlx: 63607 MSF B

United Nations Children's FundUNICEF Plads, FreeportDK-2100 Copenhagen 0, DenmarkTel: 45 35 27 35 27Fax: 45 35 26 94 21

United Nations High Commissioner for RefugeesCase postale 2500CH- 1211 Geneva 2 Depot, SwitzerlandTel: 4122 739 8111Fax: 41 22 731 9546TIlx: 28741 HCR CH

United Nations Development ProgrammeInter-Agency Procurement Services OfficeMidtermolen 3, PO Box 2530DK-2 100 Copenhagen 0, DenmarkTel: 45 35 46 70 00Fax: 45 35 46 70 01Tlx: 27 38 iaps-dkE-mail: [email protected]: www.iapso.org

Research Foundation for Microbial Diseases of Osaka University (The)3-1 Yamada-OkaSuitaOsaka 565 Japan


VACCINE SUPPLIERS TO UN AGENCIES (As of November 1998)

BCG: Chiron Behring, Intervax (NCIPD, Bulgaria), Japan BCG, Medeva, Pasteur MerieuxConnaught (France) Statens Seruminstitut Copenhagen

DTP: Chiron Behring, Chiron Vaccines (Italy), Pasteur Merieux Connaught (Canada), CSL, PasteurMerieux Connaught (France), Serum Institute of India

DT: Chiron Behring, Pasteur Merieux Connaught (Canada), CSL, Human Co, Pasteur MerieuxConnaught (France), Chiron Vaccines (Italy), Serum Institute of India, Swiss Serum and VaccineInstitute

TT: Chiron Behring, Pasteur Merieux Connaught (Canada), CSL, Human Co, Pasteur MerieuxConnaught (France), Chiron Vaccines (Italy), Serum Institute of India, Swiss Serum and VaccineInstitute

OPV: Chiron Behring, Pasteur Merieux Connaught (Canada), Pasteur Merieux Connaught (France),Chiron Vaccines (Italy), SmithKline Beecham, Bio Farmna

Measles: Pasteur Merieux Connaught (Canada), Eisai/Biken, Medeva, Pasteur Merieux Connaught(France), Chiron Vaccines (Italy), Serum Institute of India, SmithKline Beecham, Swiss Serum andVaccine Institute, Bio Farma

Hepatitis B: Cheil Jedang (plasma derived), SmithKline Beechamn (recombinant), Korean GreenCross Corporation (plasma derived and recombinant vaccines), Lucky Goldstar (recombinant)

Yellow Fever: Pasteur Merieux Connaught (France), Medeva, Institut Pasteur Dakar

Hib: Pasteur Merieux Connaught (France), Chiron Vaccines (Italy), SmithKline Beecham (Belgium),Wyeth Lederle Vaccines and Pediatrics (USA)

Meningococcal type A+ C vaccine: Pasteur Merieux Connaught (France), SmithKline Beecham

DTP-Iep B combined vaccine: SmithKline Beecham

THE WORLD BANK

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Washington, D.C. 20433 USA

Telephone: 202-477-1234

Facsimile: 202-477-6391

Telex: MCI 64145 WORLDBANK

MCI 248423 WORLDBANK

Internet: www.worldbank.org

E-mail: [email protected]

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