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HP09-2012SD/01 Contract Circular
Up to 31 July 2014 1
Item No Description Quantity Awarded
Split Supplier Name Supplier Code
Brand name Unit Price Unit Pack Shipper Pack
Lead Time (Days)
MOQ Total score
National Stock Number
3 Acetyl Cysteine 200mg soluble tablets, 20 - 25 tablets
10,000 100% Sandoz South Africa (Pty) Ltd
VVZ69 ACC 200MG 25 EFFERVES TAB FP
R 31.0900 25 effervescent tablets
25 effervescent tablets
42 1 93.00 181896924 CO
13 ALLOPURINOL 300mg tablet,28 tablets as a prp
659,400 100% Pharmacare Limited V2205 Puricos Tabs 300mg
R 11.0352 28 tabs n/a 42 60 98.00 181896927 PG
15 ALUMINIUM HYDROXIDE DRIED GEL 250mg and MAGNESIUM TRISILICATE 500mg tablet, 24 tablets as a patient-ready pack
3,906,300 100% BE-TABS Pharmaceuticals Pty Ltd
V4728 Aciban 24's (PRP's)
R 3.4000 1 x 24's 1 42 200 90.00 180339400 PG
24.1 Amitriptyline 25mg; 500 tablets 20,000 100% Gulf Drug Company (Pty) Ltd
VTS03 Gulf Amitriptyline 25
R 34.2000 500 20 45 40 95.00 189710122 CO
28 ASPIRIN 300mg soluble scored tablet, 14 tablets as a patient-ready pack
18,428,000 100% Resmed Healthcare CC
VMS39 Soluspirin R 3.1920 14 1x 500 x 14
42 500 x 14 100.00 189753742 PG
29 ASPIRIN 300mg soluble tablet, scored, 96 tablets
51,600 100% Resmed Healthcare CC
VMS39 Soluspirin R 21.5460 96 1 x 50 x 96 42 50 x 96 100.00 189714405 CO
66 CARVEDILOL 25mg scored tablet, 30 tablets
387,600 100% Medpro Pharmaceutica (Pty) Ltd
VSW29 CARLOC 25MG 30'S
R 21.8530 1 2100 42 1 94.00 180155487 CO
83 CINNARIZINE 25mg tablet, 50 tablets 100,000 100% Janssen Pharmaceutica (Pty) Ltd
V6205 Stugeron R 83.7900 50 tablets
N/A 42 1 x 50 tablets
90.00 189710220 CO
103 DIAZEPAM 5mg scored tablet, 500 tablets
18,900 100% BE-TABS Pharmaceuticals Pty Ltd
V4728 Betapam 5mg 500's
R 14.7600 1 x 500's 1 42 144 90.00 189712707 CO
104 DICLOFENAC SODIUM 25mg enteric coated tablet, 15 tablets as a patient ready pack.
1,711,000 100% Biotech Laboratories (Pty) Ltd
VUV35 DICLOFENAC 25 BIOTECH Tablets 15's
R 3.2000 1 x 15's 100 x 1 x 15's
21 100 94.00 181868878 PG
105 DICLOFENAC SODIUM 25mg enteric coated tablet, 42 tablets as a patient-ready pack
569,800 100% Biotech Laboratories (Pty) Ltd
VUV35 DICLOFENAC 25 BIOTECH Tablets 42's
R 4.2000 1 x 42's 100 x 1 x 42's
21 100 94.00 181798149 PG
HP092012SD/01: SUPPLY AND DELIVERY OF SOLID DOSAGE FORMS AND TRANDERMAL PATCHES TO THE DEPARTMENT OF HEALTH FOR THE PERIOD UP TO 31 JULY 2014
HP09-2012SD/01 Contract Circular
Up to 31 July 2014 2
Item No Description Quantity Awarded
Split Supplier Name Supplier Code
Brand name Unit Price Unit Pack Shipper Pack
Lead Time (Days)
MOQ Total score
National Stock Number
106 DICLOFENAC SODIUM 25mg enteric coated tablet, 84 tablets as a patient ready.
642,500 100% Biotech Laboratories (Pty) Ltd
VUV35 DICLOFENAC 25 BIOTECH Tablets 84's
R 5.5000 1 x 84's 100 x 1 x 84's
21 100 94.00 181868881 PG
136 ESTRADIOL VALERATE 2mg tablet, 11 tablets, ESTRADIOL VALERATE 2mg and NORGESTREL 0,5mg tablet, 10 tablets and INERT tablet, 7 tablets, Biphasic, 28 tablets
59,600 100% Pharmacare Limited V2205 Postoval Tabs R 39.7632 28 tabs 120 x 10 x 28
42 n/a 98.00 189707481 CO
161 FUROSEMIDE 40mg tablet, 1000 tablets
21,500 100% Pharma-Q Pty Ltd V1NK1 Dinoretic R 72.9900 1000 1 42 25 90.00 189714165 CO
161.1 FUROSEMIDE 40mg tablet, 5000 tablets
2,000 100% BE-TABS Pharmaceuticals Pty Ltd
V4728 Beurises 40mg 5000's
R 247.6200 1 x 5000's
1 42 20 90.00 189715350 CO
190 HYDRALAZINE HCl 50mg sugar coated tablet, 500 tablets
1,000 100% Sandoz South Africa (Pty) Ltd
VVZ69 HYDRALAZINE HCL 50MG 500 TAB FP
R 199.8300 500 500 6 weeks 1 93.00 189710397 CO
238 MAGNESIUM CHLORIDE 500mg - 700mg slow release tablet, 60 tablets
142,000 100% Merck Pty Ltd V3018 Slow Mag Tablets
R 19.6400 60 1 42 20 94.00 180000609 CO
270 MIFEPRISTONE 200mg tablet, 3 tablets
40,000 100% Medi-Challenge (Pty) Ltd
VVP11 MIFEGYNE R 684.0000 1 10 Ex Stock - 7 days
20 90.00 181830030 CO
274 MONTELUKAST 5mg chewable tablet, 28 tablets
4,000 100% Dr. Reddy's Laboratories (Pty) Ltd
V1A08 Topraz 5 R 46.0000 28 480 42 5 90.00 180344234 CO
323 PHENOBARBITONE 30mg tablet, 1000 tablets
2,700 100% BE-TABS Pharmaceuticals Pty Ltd
V4728 Sedabarb 30mg 1000's
R 40.5400 1 x 1000's
1 42 144 90.00 180280766 CO
345.1 PREDNISONE 5mg tablet, 5000 tablets 2,000 100% Gulf Drug Company (Pty) Ltd
VTS03 Trolic R 370.5000 5000 25 45 75 95.00 189715344 CO
347 PROMETHAZINE HCl 10mg tablet, 100 tablets
163,300 100% Sanofi-Aventis South Africa Pty Ltd
V2160 Phenergan Tabs 10mg 100's
R 33.5300 1 100 42 1 94.00 189710047 CO
348 PROMETHAZINE HCl 25mg tablet, 100 tablets
164,700 100% Sanofi-Aventis South Africa Pty Ltd
V2160 Phenergan Tabs 25mg 100's
R 68.9700 1 100 42 1 94.00 189710049 CO
HP09-2012SD/01 Contract Circular
Up to 31 July 2014 3
Item No Description Quantity Awarded
Split Supplier Name Supplier Code
Brand name Unit Price Unit Pack Shipper Pack
Lead Time (Days)
MOQ Total score
National Stock Number
368 ROPINIROLE HCI 0.25mg tablet, 84 tablets
1,000 100% Pharmacare Limited V2205 Requip Tabs 0.25mg
R 89.8776 84 tablet container
144 x 84 tablet container
42 1 98.00 181809452 CO
369 ROPINIROLE HCI 0.5mg tablet, 84 tablets
1,300 100% Pharmacare Limited V2205 Requip Tabs 0.5mg
R 167.6370 84 tablet container
144 x 84 tablet container
42 1 98.00 181809456 CO
370 ROPINIROLE HCI 1mg tablet, 84 tablets
1,400 100% Pharmacare Limited V2205 Requip Tabs 1mg
R 221.5362 84 tablet container
144 x 84 tablet container
42 1 98.00 181809457 CO
371 ROPINIROLE HCI 5mg tablet, 84 tablets
300 100% Pharmacare Limited V2205 Requip Tabs 5mg
R 671.5398 84 tablet container
144 x 84 tablet container
42 1 98.00 181860070 CO
388 SULPHASALAZINE 500mg enteric coated tablet, 100 tablets
115,900 100% Pfizer Laboratories (Pty)
V2189 Salazopyrin EN 500mg TAB
R 223.9100 1 96 42 1 93.00 189714546 CO
431 VIGABATRIN 500mg tablet, 100 tablets
1,100 100% Sanofi-Aventis South Africa Pty Ltd
V2160 Sabril Tabs 500mg 100's
R 930.3100 1 45 42 1 94.00 180115255 CO
450 ZINC tablet, scored, dispersible, equivalent to elemental zinc 20mg, 10 tablets
100,000 100% Zinplex Marketing CC V22Z6 Zinplex R 7.7100 10 tablets
100 units per box
5 100 units 90.00 181896936 CO
451 ZINC tablet, scored, dispersible, equivalent to elemental zinc 20mg, 100 tablets
10,000 100% Zinplex Marketing CC V22Z6 Zinplex R 17.8000 100 tablets
100 units per box
5 100 units 90.00 181862059 CO
Special Requirements and Conditions of Contract
HP09-2012SD / 01
THE SUPPLY AND DELIVERY OF SOLID DOSAGE FORMS AND TRANSDERMAL PATCHES TO THE DEPARTMENT OF HEALTH
FOR THE PERIOD UP TO 31 JULY 2014
VALIDITY PERIOD 120 DAYS
National Department of Health
1. SPECIAL CONDITIONS OF CONTRACT .................................................................................................................. 4
2. EVALUATION CRITERIA........................................................................................................................................... 4
2.1 Preference Points System ...................................................................................................................................... 4
2.2 Designation ............................................................................................................................................................. 6
3. PRE AWARD SUPPLIER DUE DILIGENCE .............................................................................................................. 6
4. PARTICIPATING AUTHORITIES............................................................................................................................... 7
5. CONTRACT PERIOD ................................................................................................................................................. 7
6. RESPONSE FIELDS .................................................................................................................................................. 7
7. VALUE ADDED TAX .................................................................................................................................................. 7
8. TAX CLEARANCE CERTIFICATE............................................................................................................................. 7
9. AUTHORISATION DECLARATION AND LEGISLATIVE REQUIREMENTS ............................................................ 8
9.1 DECLARATION OF AUTHORISATION..................................................................................................................... 8
9.2 LEGISLATIVE REQUIREMENTS.............................................................................................................................. 9
9.3 NON COMPLIANCE.................................................................................................................................................. 9
10. CONTRACT ADMINISTRATION..............................................................................................................................10
11. COUNTER CONDITIONS.........................................................................................................................................10
12. PROHIBITION OF RESTRICTIVE PRACTICES ......................................................................................................10
13. FRONTING ...............................................................................................................................................................11
14. PRODUCT COMPLIANCE .......................................................................................................................................12
14.1 PRE AWARD PRODUCT COMPLIANCE PROCEDURES .....................................................................................12
14.2 SAMPLES ...............................................................................................................................................................12
15. AWARD CONDITIONS.............................................................................................................................................13
16. PRICE QUALIFICATION AND CONTRACT PRICE ADJUSTMENT PROCEDURE ...............................................15
16.1 PRICING STRUCTURE ..........................................................................................................................................15
16.2 PRICE ADJUSTMENTS ..........................................................................................................................................16
16.3 PRICE ADJUSTMENT PERIODS ...........................................................................................................................18
16.4 RATES OF EXCHANGE (RoE) – BASE AND AVERAGE RATES..........................................................................19
16.5 GENERAL ...............................................................................................................................................................20
17. QUANTITIES, ORDERS AND DELIVERY ...............................................................................................................20
17.1 DELIVERY ADHERENCE.......................................................................................................................................20
17.2 QUANTITIES AND ORDERS..................................................................................................................................21
17.3 MANUFACTURING INFORMATION ......................................................................................................................22
18. PACKAGING ............................................................................................................................................................22
19. LABELS AND PACKAGE INSERTS........................................................................................................................23
20. CONTAINERS ..........................................................................................................................................................25
21. STERILITY................................................................................................................................................................25
22. BARCODES..............................................................................................................................................................25
23. INSPECTION AND ASSAY ......................................................................................................................................25
24. QUALITY ..................................................................................................................................................................26
25. SHELF-LIFE .............................................................................................................................................................26
26. POST AWARD .........................................................................................................................................................28
26.1 MERGERS AND TAKEOVERS ……………………………………………………… …………………………...28
26.2 MONITORING ……………………………………………………………………………………………………………… …28
27. REPORTING AND HISTORICAL DATA ..................................................................................................................27
27.1 HISTORICAL DATA ................................................................................................................................................27
27.2 PERFORMANCE MEASURES ...............................................................................................................................28
27.2.1 SUPPLIERS MEASURES .......................................................................................................................................28
27.2.2 END USER MEASURES.........................................................................................................................................28
28. CONTACT DETAILS ………………………………………………… …………………………………………………….29
29. ABBREVIATIONS ...................................................................................................................................................28
1. SPECIAL CONDITIONS OF CONTRACT
This bid and all contracts emanating there from will be subject to the General
Conditions of Contract issued in accordance with Treasury Regulation 16A
published in terms of the Public Finance Management Act, 1999 (Act 1 of
1999). The Special Conditions of Contract are supplementary to that of the
General Conditions of Contract. Where, however, the Special Conditions of
Contract are in conflict with the General Conditions of Contract, the Special
Conditions of Contract will prevail.
2. EVALUATION CRITERIA
2.1 Preference Points System
a. In terms of regulation 6 of the Preferential Procurement Regulations pertaining to
the Preferential Procurement Policy Framework Act, 2000 (Act 5 of 2000),
responsive bids will be adjudicated by the Department of Health on the 90/10-
preference point system in terms of which points are awarded to bidders on the
basis of:
- The bid price (maximum 90 points)
- B-BBEE status level of contributor (maximum 10 points)
b. The following formula will be used to calculate the points for price:
Ps = 90 min
min1
P
PPt
Where
Ps = Points scored for comparative price of bid under consideration
Pt = Comparative price of bid under consideration
Pmin = Comparative price of lowest acceptable bid
A maximum of 10 points may be allocated to a bidder for attaining their
B-BBEE status level of contributor in accordance with the table below
B-BBEE Status
Level of Contributor Number of Points
1 10
2 9
3 8
4 5
5 4
6 3
7 8
Non-compliant contributor 0
c. Bidders are required to complete the preference claim form (SBD 6.1) in order to
claim the B-BBEE status level points.
d. The points scored by a bidder in respect of the level of B-BBEE contribution will be
added to the points scored for price.
e. Only bidders who have completed and signed the declaration part of the tender
documentation may be considered.
f. The Department of Health may, before a bid is adjudicated or at any time, require
a bidder to substantiate claims it has made with regard to preference.
g. The points scored will be rounded off to the nearest 2 decimals.
h. In the event that two or more bids have scored equal total points, the contract will
be awarded to the bidder scoring the highest number of preference points for B-
BBEE.
i. A contract may, on reasonable and justifiable grounds, be awarded to a bid that did
not score the highest number of points.
j. The Department of Health reserves the right to negotiate prices
k. The Department of Health reserves the right not to award a line item.
2.2 DESIGNATION
a. In terms of regulation 9 of the Preferential Procurement Regulations pertaining to
the Preferential Procurement Policy Framework Act, 2000 (Act 5 of 2000), the
Department of Trade and Industry has designated Solid Dosage Forms included in
this contract to pharmaceutical manufacturers that formulate the medicine within
South Africa. It is envisaged that 70% of these products (by volume) may be
awarded to such local pharmaceutical manufacturers, hereinafter referred to as
Local Manufacturers.
b. Preference will be given to 70% of volume to Local Manufacturers provided that
bidders qualifying for preference regarding local content meet the following criteria:
Adherence to all aspects stipulated in the Special Conditions of
Contract; and
Bids are within 10% of the highest points scored; and / or
The provided reference price is not exceeded.
Demonstrated capacity to provide required quantity (by completing due
diligence questionnaire PBD2)
c. Item awards and splits will be done in view of this designation for local preference
– See Section 15.
d. Local content must be declared on Form PBD3 and must be calculated on the
VAT-exclusive bid price. This document must be signed by the Chief Executive
Officer of the Bidder per product in order to be considered for local content.
3. PRE AWARD SUPPLIER DUE DILIGENCE
The Department of Health reserves the right to conduct supplier due diligence
prior to final award. This may include site visits and confirmation of authenticity
of local content claims.
4. PARTICIPATING AUTHORITIES
The National Department of Health and the following Provincial Departments will
participate in this contract:
Provincial Departments of Health: Eastern Cape, Free State, Gauteng, KwaZulu-
Natal, Limpopo, Mpumalanga, Northern Cape, North West and Western Cape
5. CONTRACT PERIOD
The contract period shall be for a period of 24 months commencing 1 August 2012
to 31 July 2014.
6. RESPONSE FIELDS
It is imperative that bidders submit responsive bids by completing all the
mandatory response fields for the individual items. In this regard bidder’s attention
is drawn to the response field and price structure explanations and examples
supplied in the bid document.
Non-compliance with this condition may invalidate the bid for the item/s
concerned.
7. VALUE ADDED TAX
All bid prices must be inclusive of 14% Value-Added Tax.
Failure to comply with this condition may invalidate the bid
8. TAX CLEARANCE CERTIFICATE
An original and valid Tax Clearance Certificate issued by the South African
Revenue Services certifying that the tax affairs of the bidder are in order must be
submitted at the closing date and time of bid. Copies or certified copies of the Tax
Clearance Certificate will not be acceptable. It is the obligation of bidders to
ensure that the Department is provided with a replacement valid Tax Clearance
Certificate after expiry of the originally submitted Certificate.
Failure to comply with this condition may invalidate the bid.
9. AUTHORISATION DECLARATION AND LEGISLATIVE
REQUIREMENTS
9.1 DECLARATION OF AUTHORISATION
a. In the event of the bidder not being the actual manufacturer and will be sourcing
the product(s) from another company (third party), a signed letter from the source
company to the bidder committing to firm supply arrangement(s) for each item,
including lead times in this regard, must accompany your bid at closing date and
time. The Bid Authorization Form (Form PBD1) must be completed and signed
giving full details of the declaration of authorisation and be submitted with bid
documents at the closing date and time of the bid.
b. The said company/manufacturer/supplier issuing such a letter must confirm that it
has familiarised itself with the item description/specification, lead times and bid
conditions and if the bid consists of more than one item, it should be clearly
indicated in respect of which item(s) the supportive letter has been issued.
c. The Department reserves the right to verify any information supplied by the bidder
in the Authorisation Declaration and should the information be found to be false or
incorrect, the Department of Health will exercise any of the remedies available to it
in the bid documents.
d. The bidder must ensure that all financial and supply arrangements for goods,
including lead times, have been mutually agreed upon between the bidder and the
third party. No agreement between the bidder and the third party will be binding on
the Department of Health.
e. It must be indicated in the letter that all the terms and conditions are mutually
agreed upon
f. Failure to submit a duly completed and signed Authorisation Declaration, with the
required annexure(s), in accordance with the above provisions may invalidate the
bid for such goods offered.
9.2 LEGISLATIVE REQUIREMENTS
a. Bidders must comply with the requirements of the Patents Act, 1978 (Act 57 of
1978) and the Trade Marks Act, 1993 (Act 194 of 1993) as amended.
Bidders must submit a copy of the actual patent or an agreement with the patent
holder with the bid document at the closing date and time of the bid.
b. Bidders must comply with any legal requirements with regard to voluntary licenses
obtained, and proof of agreements in this regard must be supplied with the bid
document at the closing date and time of the bid.
c. The bidder offering medicines in terms of this bid must be licensed with the
Medicines Control Council (MCC) in terms of section 22C (1) (b) of the Medicines
and Related Substances Act, Act 101 of 1965, as amended, and must be the
holder of the license according to section 22C (6) of the said Act. A certified copy of
the licence including all annexure thereto must be submitted with the bid document,
at the closing date and time of bid.
d. Medicines offered by bidders must be registered in terms of section 15 of the
Medicines and Related Substances Act, Act 101 of 1965 as amended, and bidders
must indicate on the item response field the registration number of such an item in
terms of the said Act. The medicines must comply with the conditions under which
the medicine is registered at the closing date and time of bid. Certified copies of
product registration certificates with the MCC should accompany the bid at closing
date and time.
e. The bidder must submit proof of current GMP compliance of all manufacturing,
packing and laboratory sites used for each product and disclose any notice of
deviation from GMP received from the MCC.
f. The bidder must submit a certified copy of a valid certificate of Registration as a
Responsible Pharmacist with the South African Pharmacy Council.
9.3 NON COMPLIANCE
Non compliance with the above mentioned (Paragraphs 9.1 and 9.2) special
conditions may invalidate the bid for such products offered
10. CONTRACT ADMINISTRATION
a. Successful bidders must advise the Cluster Manager: Pharmaceutical Policy and
Planning immediately when unforeseeable circumstances will adversely affect the
execution of the contract. Full particulars of such circumstances as well as the
period of delay must be furnished within a week of identifying such a problem.
b. The administration and facilitation of the contract will be the responsibility of
National Department of Health and all correspondence in this regard must be
directed to one of the following addresses:
Director: Affordable Medicines
Department of Health
Private Bag X828
PRETORIA 0001
Civitas Building
Room 501 South Tower
242 Struben Street
PRETORIA 0002
c. The Department of Health may communicate with bidders where clarity is sought
after the closing date of the bid and prior to the award of the contract, or to extend
the validity period of the bid, if necessary.
d. All communication between the bidder and the Department of Health must be done
in writing.
e. Any communication to any government official or a person acting in an advisory
capacity for the Department in respect of this bid between the closing date and the
award of the bid by the bidder is discouraged.
11. COUNTER CONDITIONS
Bidders’ attention is drawn to the fact that amendments to any of the Bid
Conditions or setting of counter conditions by the bidders may result in the
invalidation of such bids.
12. PROHIBITION OF RESTRICTIVE PRACTICES
a. In terms of section 4 (1) of the Competition Act No. 89 of 1998, as amended, an
agreement between, or concerted practice by, firms, or a decision by an
association of firms, is prohibited if it is between parties in a horizontal
relationship and if a bidder (s) is / are or a contractor(s) was / were involved in:
directly or indirectly fixing a purchase or selling price or any other trading
condition;
dividing markets by allocating customers, suppliers, territories or specific types
of goods or services; or
collusive bidding.
b. Section 4 (2) of Act No.89 of 1998 as amended states that an agreement to
engage in a restrictive horizontal practice referred to in subsection (1)(b) of the Act
is presumed to exist between two or more firms if:
any one of those firms owns a significant interest in the other, or they have at
least one director or substantial shareholder in common; and
any combination of those firms engages in that restrictive horizontal practice.
c. If a bidder(s) or contractor(s), in the judgment of the purchaser, has / have engaged
in any of the restrictive practices referred to above, the purchaser may refer the
matter to the Competition Commission for investigation and possible imposition of
administrative penalties as contemplated in the Competition Act No. 89 of 1998.
d. If a bidder(s) or contractor(s) has / have been found guilty by the Competition
Commission of any of the restrictive practices referred to above, the purchaser
may, in addition and without prejudice to any other remedy provided for, invalidate
the bid(s) for such item(s) offered, and / or terminate the contract in whole or part,
and / or restrict the bidder(s) or contractor(s) from conducting business with the
public sector for a period not exceeding ten (10) years and / or claim damages from
the bidder(s) or contractor(s) concerned.
13. FRONTING
a. The National Department of Health supports the spirit of broad based black
economic empowerment and recognizes that real empowerment can only be
achieved through individuals and businesses conducting themselves in accordance
with the Constitution and in an honest, fair, equitable, transparent and legally
compliant manner. Against this background the National Department of Health
condemns any form of fronting.
b. The National Department of Health, in ensuring that bidders conduct themselves in
an honest manner will, as part of the bid evaluation processes, conduct or initiate
the necessary enquiries/investigations to determine the accuracy of the
representation made in bid documents. Should any of the fronting indicators as
contained in the Guidelines on Complex Structures and Transactions and Fronting,
issued by the Department of Trade and Industry, be established during such
enquiry / investigation, the onus will be on the bidder / contractor to prove that
fronting does not exist. Failure to do so within a period of 14 days from date of
notification may invalidate the bid / contract and may also result in the restriction of
the bidder /contractor to conduct business with the public sector for a period not
exceeding ten years, in addition to any other remedies the National Department of
Health may have against the bidder / contractor concerned.
14. PRODUCT COMPLIANCE
14.1 PRE AWARD PRODUCT COMPLIANCE PROCEDURES
The following pre-award product compliance procedures will apply:
a. Compliance to specifications as stated in the bid document.
b. Certified copy of product registration with Medicines Control Council (MCC) where
applicable
c. Compliance to Good Manufacturing Practice where applicable
d. Valid relevant licence from Medicines Control Council where applicable
e. Submission of completed and signed Due Diligence Questionnaire (PBD2) and
Local Content Questionnaire (PBD3)
f. Submission of samples of the relevant products on or before the closing date and
time of the bid at the addresses indicated in paragraph 14.2.
14.2 SAMPLES
a. No samples must be sent to the Pharmaceutical Policy and Planning unit of the
National Department of Health.
b. Samples must be submitted to each of the addresses indicated below, to be
received before or at closing date and time of bid:
Ms Santie Van Dyk
Tel: 011 628 9003
Gauteng: Medical Supplies Depot
Store 3
35 Plunkett Avenue
Hurst Hill 2092
Ms Helen Hayes
Tel: 021 483 4567
Western Cape Department of Health
Pharmaceutical Services
4 Dorp Street Room T14-02
Cape Town 8001
c. For accurate evaluation of samples, bidders must submit in original packaging at least one
original pack of each offer
d. Bids not supported by samples will be disregarded in respect of the items for which
samples are not submitted.
e. Samples of items offered must be marked with the bid number, the item number as well as
the bidder’s name and address.
f. It is the responsibility of the bidders to ensure receipt of the samples at the testing
authorities described in section 13.2 (b).
g. Samples submitted by unsuccessful bidders must be collected by them within 3 months of
the commencement of the contract. Samples not collected within this 3 month period will
be destroyed.
h. Samples of all products accepted against this bid will be retained for the duration of the
contract period.
i. All samples must be a true representation of the product which will be supplied.
j. All samples of registered medicines must be submitted with the MCC approved/registered
package insert.
k. No samples will be required for schedule 6 items.
15. AWARD CONDITIONS
a. The Department of Health will apply preference to Local Manufacturers. If local content of a
product offered meets the criteria set out in paragraph 2.2 b, preference will be given to
such bid(s).
b. The Department of health reserves the right to issue multiple awards. The decision to issue
multiple awards is based on estimated volume to be supplied, risk to public health if the
item is not available and capability of bidder to supply the volume awarded. Where multiple
awards are necessary domestic producers will be given preference based on the criteria
below:
c. Single award
If there are no local manufacturers within 10% of the highest scoring bidder then 100 % of
the volume may be awarded to the highest scoring bidder.
Where a local manufacturer scores within 10% of the highest points, then 100% volume
may be awarded to the local producer, irrespective of highest points scored.
d. Split award (2)
The local manufacturer with the highest points and within 10% of the bidder with the highest
points may be awarded 70% of the volume. The bidder with the highest points may be
awarded 30% of volume
Where there is no local manufacturer within 10% of the highest points then the volume
distribution as described in table below will be applied.
Where the bidder with the highest points is also a local manufacturer then the local
manufacturer may be awarded 80% of the volume if the difference in points (compared to
the second highest bidder) is between 10.1% and 20%.
Category Difference between points Recommended percentage split
A Equal points – 1% 50/50
B 1,1% – 5 % 60/40
C 5,1% - 10% 70/30
D 10,1% – 20 % 80/20
e. Multiple award (3)
Where there is no local manufacturer within 10% of the highest score then the volume
distribution as described in the formula below will be applied.
Where there is only one local manufacturer within 10% of the highest score then the local
producer will be allocated 50% of the total volume. The remaining 50% of the volume
allocation to each bidder will be based on the formula below using their individual scores.
Where there are two local producers within 10% of the highest points then the combined
allocation to the two bidders will be 70% of the total volume. The individual volume
allocation of the 70% to each bidder will be based on the formula below using their
individual points. The bidder scoring the highest points will be allocated 30%.
Where there are three local producers within 10% of the highest points then the volume
distribution amongst the three shall be as described in the formula below.
Supplier portion = [1/N * 100]% + [Supplier score – Mean score] * 0.23%
where N= the number of bids accepted.
f. The following conditions will apply to all multiple or split awards:
A single bidder will not be awarded more than one portion for the same line item.
The Department of Health reserves the right not to split award amongst bidders using
the same API source and / or manufacturer.
g. The Department of Health reserves the right to determine the number of awards per lineitem.
16. PRICE QUALIFICATION AND CONTRACT PRICEADJUSTMENT PROCEDURE
16.1 PRICING STRUCTURE
a. Prices submitted for this bid will be regarded as non-firm and subject only to
adjustment(s) in terms of the formula under paragraph 16.2, defined areas of cost
and defined periods of time.
b. Bidders should quote a final delivered price.
c. Final price must include API price, formulation cost, packaging, transport cost,
Value Added Tax, etc. Bidders are referred to the pricing schedule in this regard.
d. Bidders should note that margins above cost cannot be adjusted.
e. Bidders are advised to refer to the Reference Price List for Solid Dosage Forms
published on the Department of Health website (www.doh.gov.za) before preparing
the bid submission.
16.2 PRICE ADJUSTMENTS
a. The Department of Health reserves the right to accept or reject any application for
price adjustment.
b. Bidders are required to complete the price breakdown in the relevant response
fields as per diagram below. Failure to provide such breakdown may exclude the
bidder from any price adjustments during the contract period
Cost component
(For fully imported or finished
products offered from another
manufacturer, API, formulation and
packaging components may be
combined)
% of total product
value
(Values in this column
must add up to 100%)
Value
(Value for “% imported” and “%
local” must add up to 100% for
each cost component)
% imported % local
API
Formulation
Packaging
Transportation N/a
Margin N/a N/a
c. Applications for price adjustments must be accompanied by documentary evidence
to support of any application.
d. The process for price adjustment will be as follows:
Identify the cost component(s) to be adjusted. Margins above cost
cannot be adjusted, thus eligible cost components include:
o Cost of the API
o Costs related to formulation
o Costs related to packaging
o Costs related to transport
Calculate price adjustment using the following formula:
= + + +
Pa = The new price to be calculated
Pt = Original award price. Note that Pt must always be the original award price
DA = The proportion of the award price attributable to API cost
RA1 = New cost of the API
RA0 = Base cost of the API
DF = The proportion of the award price attributable to formulation cost
RF1 = The new cost of formulation
RF0 = The base cost of formulation
DT = The proportion of the award price attributable to transport cost
RT1 = The new cost of transport
RT0 = The base cost of transport
PM=
The proportion of the award price that is attributable to margin above cost; this variable is not adjustable
e. Costs associated with normal business risk are not eligible for adjustment, but
unforeseen costs that may impact continuous supply will be considered.
f. Applications for price adjustments may be submitted by the half-yearly review dates
stipulated in section 16.3 and must be accompanied by documentary evidence of the
circumstances that are claimed to warrant a price adjustment.
g. Information required to assess price adjustment requests is as follows:
For adjustments related to API price changes, suppliers must submit the
following:
o Documentation of the current cost of the API
o Documentation of the new cost of the API
For adjustments related to formulation or transport price changes, suppliers must
submit the following:
o A description of why the adjustment is necessary
o Documentation of the current cost of the cost component
o Documentation of the new cost of the cost component
h. Successful bidders can apply for adjustments relating to one or more than one
combination of the above factors.
i. Contracted suppliers are expected to continue to supply the product without interruption
at the contracted price until advised of the outcome of a price adjustment application.
j. No retroactive price increases will be permitted for purchase orders already issued to
and accepted by the manufacturer.
k. Where the Department of Health is not satisfied with the documentation submitted, it
could grant a lower adjustment or deny the request altogether.
l. All requests for price adjustments will be based on the original award price – and not on
any previously adjusted price.
m. Should the Department of Health choose to initiate a price adjustment (decrease) for a
particular product, the following factors will be taken into account to determine the
revised prices:
Material reductions in the cost of the API, as determined by a composite index of
API costs linked to international prices for products in question;
Feasibility of using an alternate source if a cheaper source of APIs is available at
the requisite quality level;
Time needed to implement necessary changes in raw material or API sources as
determined by regulatory processes mandated by the MCC and other regulatory
bodies in question;
Other material reductions in the cost of Production based on changes in
technology or alternate routes of production becoming available or substantially
higher volumes than anticipated resulting in a drop in fixed manufacturing costs.
16.3 PRICE ADJUSTMENT PERIODS
Adjustment to contract prices may be applied for at the following dates:
Adjustment
Application for price adjustment to reach the office by the following dates
Dates from which adjusted prices will become effective
1st Adjustment 5 January 2013 1 February 2013
2nd Adjustment 5 July 2013 1 August 2013
3rd Adjustment 5 January 2014 1 February 2014
16.4 RATES OF EXCHANGE (RoE) – BASE AND AVERAGE RATES
In the event where material and/or finished products are imported the following will
apply:
a. The formula described in par. 14.2 will be used and ONLY the imported cost component
of the bid price will be adjusted taking into account the base RoE and the average RoE
rate over the period under review indicated in paragraph (d) below.
b. Rate(s) of exchange to be used in this bid in the conversion of the price of the item(s) to
South African currency.
Currency Rates of exchangeAverage for the period 1 May 2012 to 31 July 2012
Dollar R 8.2757
Br Pound R 13.0114
Euro R 10.4748
Yen R 0.1042
c. Should the bidder make use of any other currency not mentioned above, the bidder is
requested to calculate the average for the period 1 May 2012 to 31 July 2012 using the
South African Reserve Bank published rates for the specific currency. Visit
www.reservebank.co.za to obtain the relevant rates.
d. Contract price adjustments due to rate of exchange variations are based on average
exchange rates as published by the Reserve Bank for the periods indicated hereunder:
Adjustment Average exchange rates for the period:
1st Adjustment 1 August 2012 – 31 December 2012
2nd Adjustment 1 January 2013 - 30 June 2013
3rd Adjustment 1 July 2013 – 31 December 2013
16.5 GENERAL
a. Unless prior approval has been obtained from National Department of Health, no
adjustment in contract prices will be made.
b. Contract Price Adjustment (CPA) applications will be applied strictly according to the
specified formula and variables above as well as the cost breakdown supplied by
successful bidders in their bid documents.
c. In the event where the supplier’s CPA application, based on the above formula and
parameters, differs from National Department of Health’s verification, National
Department of Health will consult with the supplier to resolve the differences.
d. Bidders are referred to paragraph 11 of the Special Conditions regarding counter
conditions.
e. An electronic price adjustment calculator will be made available on the Department of
Health’s website and will be communicated.
17. QUANTITIES, ORDERS AND DELIVERY
17.1 DELIVERY ADHERENCE
a. For each product, bidders must explicitly indicate the minimum and maximum volumes
that they can supply on a monthly, quarterly (3-monthly) and annual basis on the
response fields.
b. Ability to supply must be maintained throughout the duration of the contract.
c. Bidders must indicate and provide assurance of ability to maintain delivery lead time
(time from placement of the order to delivery at the provincial medical store or delivery
point) of less than 6 weeks for the duration of the contract.
d. Delivery of products must be made in accordance with the instructions appearing on the
official order forms emanating from the above mentioned Participating Authorities and
institutions placing the orders.
e. All deliveries or dispatches must be accompanied by a delivery note stating the official
order number against which the delivery has been effected.
f. In respect of items awarded to them, contractors must adhere strictly to the delivery
periods quoted by them in their bids.
g. The instructions appearing on the official order form regarding the supply, dispatch and
submission of invoices must be strictly adhered to.
h. All invoices should be delivered / posted to reach the institution that placed the order
timeously. The invoices should be original and accompanied by proof of delivery.
i. Deliveries must be in accordance with official orders and any deviation will be returned
to the contractor at the contractor’s expense.
j. Deliveries must conform to cold chain distribution requirements, if applicable. Normal
storage conditions (25 degrees Celsius) must not be exceeded.
17.2 QUANTITIES AND ORDERS
a. The ordered quantities are required for delivery as indicated by the particular
participating departments.
b. Suppliers should under no circumstances deviate from the orders issued by the
departments.
c. The Department of Health is under no obligation to purchase any stock, which is in
excess of the indicated quantities for any item.
d. The quantity indicated against each item represents the total estimated off-take of all
participating departments as per paragraph 4.
e. Bidders should note that the order/s will be spread out throughout the contract period
and that delivery points will be to the individual Provincial Depots or institutions.
f. Bids must be for supply ex duty paid stocks held in the Republic of South Africa during
the contract period.
g. The quantities reflected in the bid documents are estimated quantities and no guarantee
is given or implied as to the actual quantity which will be ordered.
h. The Department of Health also reserves the right to purchase its requirements
elsewhere outside the contract in terms of clause 21 of the General Conditions of
Contract if:
Minimum order quantity specified by the contractor be more than that of an
institution’s requirements
The item(s) are urgently required and not immediately available
An emergency arises
If the contractor fails to perform in terms of this contract
i. The Department of Health reserves the right to change drug regimens and/or product
formulations if necessary due to emerging clinical evidence, disease profiles, reported
adverse drug reactions or resistance patterns.
17.3 MANUFACTURING INFORMATION
a. Bidders must disclose the manufacturing site(s) as well as the API supplier(s), as
approved by or submitted to the MCC.
b. Bidders must be able to substantiate the API price provided.
18. PACKAGING
a. All deliveries made against this contract whether by road or rail are to be packed in
containers, which will be acceptable for further dispatch by rail. Attention is drawn to the
requirements of the Transnet Fright Rail Standard Conditions of Carriage Policy (Check
Relevance).
b. The number of “PACK” items in the commercial packing must appear on the bid
documents. The packing must be uniform for the duration of the contract period, i.e.:
The number of “PACK” items per commercial packing.
The number of commercial packing per carton.
The number of cartons per bulk packing.
The conditions under which the product must be stored.
c. The following information must be clearly and indelibly printed on all inner and outer bulk
packing in letters not less than 10mm in height:
Name and strength of item and quantity
Date of manufacture.
Expiry date.
Batch number.
d. Outer wrappers of patient-ready packs must be labelled with the number of packs within
the wrapper
19. LABELS AND PACKAGE INSERTS
a. Labels and package inserts for medicines intended for administration to humans, must
comply with the Medicines and Related Substances Act, 1965 (Act 101 of 1965) as
amended.
b. Bids indicated as patient-ready pack must comply with all the standards as laid down by
the Medicines Control Council.
c. Where patient-ready packs (PRP) are specified, these should be made available in one of
the two forms mentioned below:
Blister pack in a square/rectangular box made of sturdy cardboard or similar
material with a matt writing surface in format as set out in the example below. The
actual format of the directions and other required information should be according to
the specification of the item.
Tamper proof re-sealable tablet bag (polyethylene polymer or a foil). The surface
must be pre-printed in a format as set out in the example below. The actual format
of the directions and other required information should be according to the
specification of the item.
d. Re-sealable tablet bags / envelopes
Special warnings and important information may be printed on the reverse side of the
package.
The surface must be pre-printed with individual blocks for inserting dosage instructions.
Unless stated otherwise in the specification, the format of the pre-printing to appear on
the square/rectangular box or re-sealable tablet bag (polyethylene polymer or a foil) must
be as set out in the example below:
The printing must be in letters not less than 10 points in height and the expiry date must
be printed or embossed onto the packet; a stick-on label will NOT be acceptable.
No conflicting information may appear on the pre-printed label
Tamper proof re-sealable tablet bag (polyethylene polymer or a foil) must comply with the
United States pharmacopoeia (USP) category “tlr” (30, 2007, volume 3 – 661 page 260 –
267).
Seals must:
be hermetic and smooth to ensure that no air can enter the bags or that the
bags are smooth on all surfaces without wrinkles visible on the sealing line
or seal itself; and
not obscure any printing or affect any information
NOT FOR SALE - FOR STATE USE ONLY
[S ] Quantity, Generic name & Strength
Proprietary Name may appear above or below generic name, but may not be larger than generic name.
Dosage and Directions for use
Take tablet(s) /capsule(s) in the morning / at breakfast
Take tablet(s) /capsule(s) at noon / lunchtime
Take tablet(s) /capsule(s) at night / suppertime
SPECIAL INSTRUCTIONS, WHERE APPLICABLE:
PATIENT’S NAME …………………………………………………..........
DATE……......………… REFERENCE NUMBER ..………....................
Store below 25ºC. Protect from light
KEEP OUT OF REACH OF CHILDREN
Space for name of institution
MCC Registration number, manufacturer name, Lot number and expiry date as per legal requirements suitably spaced
e. Labels printed on containers offered as patient-ready packs must be of an appropriate
size and format to allow legible and clear writing of instructions and patient particulars
as per the tablet bag labelling above.
20. CONTAINERS
The function of a container for a medicinal preparation is to maintain the quality, safety
and stability of its contents. Containers should withstand the mechanical hazards of
handling and transport, prevent leakage, and provide an appropriate level of protection
from environmental conditions. Conditions of container must be acceptable to purchaser
at the point of delivery. Ideally, the materials of construction should have no chemical or
physical effect on the preparation, and, for liquid preparations, should be sufficiently
transparent to permit inspection of the contents whilst providing protection from incident
radiation when necessary.
21. STERILITY
a. All relevant preparations are to be supplied sterile and apyrogenic.
22. BARCODES a. It is a specific condition of all pharmaceutical bids that the packaging of all products
supplied to the State must include a barcode (number plus symbology). Both the outer
case and the specification pack must be marked with the appropriate number and
symbology. The European Article Numbering Code 13 (EAN 13) has been accepted as
standard. The batch number and the expiry date should be included in the barcode, if
possible.
b. Bidders who are already in possession of the necessary block of numbers are
requested to submit the EAN 13 numeric code(s) for each of the products offered as
well as the outer case coding applicable to the distribution pack(s) (ITF 14) together with
the quantity of items contained in such packs.
23. INSPECTION AND ASSAY
a. A valid certificate of analysis per batch, not older than two years from date of issue, must
accompany every delivery of raw materials when requested.
b. All deliveries to authorised participants will be subject to a visual examination and
scrutiny by the relevant participant and/or assay by the Laboratories as indicated in
paragraph 13.2 (g)
24. QUALITY
a. Products supplied in consequence of this bid must conform in every respect with the
conditions of registration lodged with Medicines Control Council
b. Where a standard for the quality of a substance is not stipulated, bidders must state whether the product offered complies with B.P., B.P.C., or any other pharmacopoeial standard.
25. SHELF-LIFE
a. Products, upon delivery, must have at least 18 months of shelf-life before date of expiry.
For patient-ready packs in foil or plastic envelopes, products must have at least 12
months of shelf-life before date of expiry.
b. Any delivery of short dated supplies without prior written approval must be collected by
the respective suppliers at their own cost.
c. Contractors may make written applications to deliver material with a shorter shelf-life,
provided such applications are accompanied by an undertaking that such short-dated
stock will be unconditionally replaced before or after expiry and that such applications
are approved before execution of the orders.
d. Provided also that any such written application must include an undertaking by the
contractor to apply the following discount formula when supplying short dated stock:
For stock other than patient-ready packs in foil or plastic envelopes:
A=2 (18 – months to date of expiry) % X consignment value short dated stock.
Therefore, amount to be invoiced is: Consignment value – A, where A is the discount
formula.
For patient-ready packs in foil or plastic envelopes:
A=2 (12 – months to date of expiry) % X consignment value short dated stock.
Therefore, amount to be invoiced is: Consignment value – A, where A is the discount
formula.
e. Any participating authority may, without prejudice, decline written applications to deliver
stock with a shelf -life of less than the above.
26. POST AWARD
26.1 MERGERS AND TAKE OVERS
a. Where a contracted supplier merges with or is taken over by another, the Department
of Health must be informed of such plans immediately. See contact details in
paragraph 26.2 below.
b. Documentation in paragraph 9 above pertaining to the new company must be submitted
to the Department of Health
c. The Department of Health reserves the right to agree to the transfer of contractual
obligations to the new supplier under the prevailing conditions of contract or to cancel
the contract.
26.2 MONITORING
The contractors must confirm compliance with the Good Manufacturing Practice. Any
change in the said status during the contract period must be reported within seven (7)
days of receipt of such notice from the Medicines Control Council to:
Pharmaceutical Policy and Planning, Affordable Medicines, Department of Health, for
attention:
Ms. Helecine Zeeman
Director: Affordable Medicines
Tel. No: 012 395 8530
Ms Phuti Moloko
Deputy Director: Procurement & Distribution
Tel. No: 012 395 8439
27. REPORTING AND HISTORICAL DATA
27.1 HISTORICAL DATA
Historical value and volume reports are required to be submitted monthly preferably via
e-mail to the Department of Health for attention of Ms P Moloko
([email protected]), Ms B. May ([email protected]) and Ms M Coetzee
([email protected]) by all successful bidders. For this purpose electronic
templates which will include orders received and deliveries made will be supplied to
successful bidders. The reports must be submitted on or before the 10th of each month.
27.2 PERFORMANCE MEASURES
27.2.1 SUPPLIERS MEASURES
a. Delivery period adherence
b. Product quality adherence
27.2.2 END USER MEASURES
a. On time payment
28. CONTACT DETAILS
Chief Directorate: Pharmaceutical Policy and Planning, Private Bag x 828, Pretoria, 0001 or
Physical address: 242 Struben Street, Civitas Building, Pretoria, 0001.
Bid Enquiries:
Phuti Moloko:
Tel: (012) 395 8439
Fax: (012) 395 8823
Specification / Technical Enquiries
Babalwa May
Tel: (012) 395 8442
Fax: 086 632 9951
29. ABBREVIATIONS
The abbreviations used in this bid signify the following:
B.P = British Pharmacopoeia (latest edition)
B.P.C. = British Pharmaceutical Codex (latest edition)
GMP = Good Manufacturing Practice
G = gram
HCG = Human Chorionic Gonadotropin
HCl = Hydrochloride
HIV = Human Immunodeficiency Virus
iu = international unit
iu/litre = international unit per litre
IV = intravenous
kg = kilogram
MCC = Medicines Control Council
mcg = microgram
mg = milligram
Mg I/ml = milligram Iodine per millilitre
ml = millilitre
m/m = mass per mass
MNN = Morning, Noon & Night (layout of labels)
pH = acid-base scale
PRP = patient-ready pack
w/w = weight/weight
