exim requlations

8/22/2019 exim requlations

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S U B M I T T E D B Y : -

A l o k k r v i s h w a k a r m a

M a h e n d r a s i n g h

A m i t v e r m a

D e p t . o f p h a r m a c e u t i c s

P s i t , k a n p u rcont.

1

Export and import regulations andmethods to obtain licence for exportand import of pharmaceuticals as

per India , U.S., EU, Japan


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INTRODUCTION

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Export is selling the drugs, pharmaceuticals, medicaldevices etc. To other countries crossing thegeographical frontiers of the country.

Import is purchases drugs from other country andbrings them in to the country crossing thegeographical borders of the country.


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General procedure for export

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Steps of export procedures :-

Receipt of indent

Receipt of license for export procurement of goods.

Packaging and labelling appointment of forwarding agentdispatch of goods.

Foreign customs permit shipping order export duty andshipment bill, Dock dues or challan loading the Matesreceipt.

Bill of loading Marine insurance forwarding agent advice. Preparation of export invoice Payment Advice to

importer.


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General procedure for import

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Steps for import:- Obtaining import licence foreign exchange Placing the indent Dispatch of goods by export agent Obtaining shipment document

Appointment of clearing agent Endorsement of delivery Payment of import duty dock dues Taking delivery of goods Keeping goods in warehouse

Dispatch of goods by clearing agent Receipt of documents Taking the delivery


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Import regulation in India

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Forms

Form 10 - import drugs excluding those specified inschedule X.

Form 10A - import drugs specified in schedule X.Registration certificate

Certificate issued under rule 27 a by licensingauthority in form 41 for registration of premises anddrugs manufactured by manufacturer meant forimport in to and use in India.


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Forms and application for import licence. Application for import licence-

Form 8 (drugs excluding those specified in schedule X)

Form 8A (import drugs specified in schedule X)

Fee

For single drug 1000 Rs

Addition fee for each additional drug- 100 Rs

No registration for import of invitro diagnostic kit andreagents.

For duplicate license (if original is damaged or lost)250 Rs shall be paid.


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cont.

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A single application be made and a single license may beissued in respect of import of more than one drugsmanufactured by same manufacturer.

Conditions of import licence :-1. Premises where imported substance will be stocked are

equipped with proper storage.2. The licensee shall allow any inspector authorized bylicensing authority in that behalf to enter with or withoutnotice .

3. Any premises where the imported substance is stocked toinspect the means any employed can come for testingsubstance and to take sample.

4. Licensee shall being informed by the licensing authoritythat any part of batch of substance has been found not toconfirm with standards of strength , quality, purity.


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cont.

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Licensee shall maintain the records of all sales by him ofsubstances for which a license is required. Licensee should maintain a records of all particulars for

schedule X drugs.

Grant of license1. License is valid for a period of three years.2. Prohibition of import after expiry of potency Standards of

certain imported drugs.3. Licensing authority shall not import of any drug having

less than 60% residual shelf life period as on date ofimport.4. Packaging and labelling should be in conformity with the

rules.


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Medical Device

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The ministry of Health and Family welfare underGazette notification S.O. 1468 (E) dated 6/10/05declared the following sterile devices to beconsidered as drug under Section 3 (b) (iv) of the Act.

1. Cardiac Stents 2. Drug Eluting Stents 3. Catheters4. Intraocular Lenses 5. I.V. Cannula 6. Bone

cements 7. Heart Valves 8. Scalp vein set 9.Orthopedic Implant

10. internal Prosthetic replacements.


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Import Of Medical Devices

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Procedure for registration and import licence asprescribed under the D&C rules shall be followed.

1. A period of 60 days would be provided for the

importers to make application for import andregistration from the date of publication of theseguidelines.

2. In case of device which have not been imported in

the country before the date of notification noimport would be permitted without the approval ofthe competent authority.


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cont.

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For the time being and for a period up to 6 month,until a application is approved or rejected, the device

which is currently in use will be permitted to besold.

Separate committees consisting of subject expert andrepresentative would be setup for their expert advicefor evaluation of specific categories of devices.

Expert committees would formulate their ownprocedure for evaluation and the standards to whichdevice should conform.


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Export regulation of India

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It was compulsory for every exporter to obtain anexporters code number from the RESERVE BANK OFINDIA before engaging in export.

Registration with regional authorities ( obtaining IEC

code number ) The customs authorities will not allow you to export or

import goods into or from India unless you hold a validIEC number.

For obtaing IEC no. you should apply to RegionalLicensing authority in duplicate.


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cont.

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Before applying for IEC no. it is necessary to openbank account in name of your company/ firm withany commercial bank authorized to deal in foreignexchange

The duly signed application form should besupported by the following document :

Bank receipt ( in duplicate).

Demand draft for payment of the fee of Rs. 1000/-

Two copies of pasport size photographs of theapplicant duly attested by the banker to theapplicants.


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cont.

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A copy of permanent account no. issued by Income TaxAuthority. If PAN has not been allotted, a copy ofapplication of PAN submitted to Income Tax Authority.

An IEC no. allotted to an applicant shall be valid for allits branches/ divisions as indicated on the IEC no..

Application for grant of export license in respect of itemsmentioned in schedule 2 of ITC (HS). Classification ofexport and import items may be made in the form givenin appendix 18A or 18B or 18C.


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Compulsory quality control and pre-shipment

inspection

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An important aspect about the goods to be exported iscompulsory quality control and pre-shipment inspection.

Under the export act 1963 pharmaceutical product aresubject to compulsory pre-shipment inspection.

At times , foreign buyers lay down their own standards/Specification which may or may not be in consonance

agencies.


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IN PROCESS QUALITY CONTROL

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The inspection is done at various stages of production.

The export has to get his unit registered as EXPORTWORTHY and keep record of processing and production.

Inspection by the officers of Export Inspection Agency isdone form time to time.

The certificate of inspection on the end-product is thengiven without in-depth study at the shipment stage.


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cont.

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Under this system, export is allowed on the adequacyof in-process quality control and inspectionmeasures exercised by the manufactured unitsthemselves.

The certificates of inspection in favor of the unitsapproved under the scheme are issued by the ExportInspection Agencies in the normal course.


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Labeling, packaging, and marking goods

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The involves labeling, packaging, packing andmarking of export consignments.

Labeling requirement differ form country to country

and the same should be ascertained well in advanceform the buyer.

The label should indicate quality, quantity, methodof use etc.

Packaging should also be in conformity with theinstruction issued by the importer.


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U.S. IMPORT REQUIREMENTS

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CONTENTS1. Import requirements.

2. Arrival of goods.

3. Entry of goods.

4. Other types of entry

5. Customs examination of goods.

6. Protest.

7. Mail shipments.

8. Restricted Merchandise

9. Foreign assets control


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U.S. IMPORT REQUIREMENTS

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An individual may make his own customs clearance ofgoods imported for personal use or business.

All merchandise coming into the United States mustclear customs and is subjected to a customers duty unlessspecifically exempted by law clearance involves a no. ofsteps- Entry, Inspection, Appraisement, Classificationand liquidation.

The U.S. Customs service does not require an importerto have license or permit.

The importer must declare the dutiable value ofmerchandise.

The importer must determination the classification no. ofthe merchandise imported.


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cont.

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The dutiable value of merchandise is determined bycustoms. Several appraisal methods are used to arriveat this value.

The Harmonized Tariff Schedule of the United States(HTSUS), issued by International Trade Commission,

prescribes the rates of duty and classification ofmerchandise by type of product e.g., animal and

vegetable products , textile fibers and textile products. The tariff schedule provides several rates of duty for

each item: general rates for most- favoured nations,

special rates for special trade programs (free, or lowerthan the rates currently accorded most favourednations) and column 2 rates for imports not eligiblefor either general or special rates.


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ARRIVAL OF GOODS

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Imported goods may not be entered legally until theshipment has arrived within the limits of the port ofentry and delivery of the merchandise has beenauthorized by customs. The is normallyaccomplished by filling the appropriate documentseither by importer or by importers agent.

Imported merchandise not entered through customs

in a timely manner (up to 30 days) is sent bycustoms to a general order warehouse to be held asunclaimed.


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ENTRY OF GOODS

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To make or file a customs entry, the following documentsare generally required:

1. A bill of lading, airway bill or carriers certificate(naming the consignee for customs purposes) as

evidence of the consignees right to make entry.2. A commercial invoice ,obtained from the seller, which

shows the value and description of the merchandise.

3. Entry manifest (Customs Form 7533) or Entry /

Immediate Delivery (Customs Form 3461).4. Packing lists, if appropriate and other documents

necessary to determine whether the merchandise maybe admitted.


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OTHER TYPES OF ENTRY

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IMPORTED GOODS MAY BE SENT IN-BONDFROM THE FIRST PORT OF ARRIVAL TO

ANOTHER CUSTOMS PORT. Arrangements for in-bond shipments should be made before the goodsleave the country of export. In- bond entriespostpone final customs formalities, includingpayment of duty and processing fee, until the goodsarrive at the final port.


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CUSTOMS EXAMINATION OF GOODS

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Examination of goods is necessary to determine:

1. The value of the goods for customs purposes and theirdutiable status.

2. Whether the goods must be marked with the country oftheir origin or with special marking or labelling.

3. Whether the shipment contains prohibited articles.

4. Whether requirements of other federal agencies have

been met.5. Whether goods excess of the invoiced quantities are

present or a shortage of goods exists.


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PROTEST

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With in 90 days, after the date of liquidation or otherdecision, an importer or consignee may protest thedecision and receive an administrative review.

The protest is filled with the port director wheredecision is being protested.

Any person whose protest has been denied maycontent the denial by filing a civil action in the U.S.

Court of inter trade.


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MAIL SHIPMENTS

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Shipments by mail which do not exceed $2000 invalue whether commercial and non commercialimportations are entered under mail entry prepared

by a customs officer after the postal service submits.


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EXPORT REGULATIONS

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The Export Administration Regulations (EAR)regulate the export and re-export of the items fornational security, non proliferation, foreign policy,and short supply reasons. The Department ofCommerces Bureau of Export administration (BXA)has taken important steps to remove unnecessaryobstacles to exporting, including completion of U.S.Regulatory reform effort and export controlliberalization license.


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APPLY FOR LICENSE

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If an export license is required, you must prepare aForm BXA- 748P, Multipurpose Application Formand submit it to BXA. The form can be used forrequesting an export license, re-exports orcommodity classification.


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MEDICAL DEVICE REGULATION OF U.S.

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Any medical device that is legally in the U.S. may beexported anywhere in the world without prior FDAnotification or approval.

The export provision under section 802 of the FD & C act

only applies to unapproved device. For a device legally in commercial distribution the U.S. , the

following requirement must be met-1. The manufacturing facility must be registered with FDA.

2. The device must be listed with FDA.

3. Device must have cleared premarket notification 510(k) or premarketapproval.

4. Device must meet labelling requirment of 21CFR part 801 and 21CFR 809, if applicable.


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IMPORT MEDICAL DEVICE

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I n order to import medical device into U.S., the productmust meet FDA regulatory requirements.

FDA dose not recognize regulatory approval from othercountries foreign manufacturers must meet applicableUnited states medical device regulations in order to importdevice into U.S. even if the product is authorized for

marketing in another country. These order include:1. Listing of device2. Manufacturing in accordance with the quality system3. Medical device reporting adverse effect

4. Premarket notification or premarket approval entry informationshould identify the product and include appropriate information todemonstrate product compliance with FDA .

5. Product information should include product name and product code.


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AVOIDING DELAY IN RECEIVING A LICENSE

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In filling out a license application, re-exporters commonly makefour errors that account for most delays in processingapplications:

1. Failing to sign the application.2. Handwriting, rather than typing the application.

3. Responding inadequately to section 22(j) of the application,Description of Commodity or Technical Data, which calls fora description of the item or items to be exported. You must bespecific, and you are encouraged to attach additional materialto explain the product fully.

4. Responding inadequately to section 21 of the application,where the specific end use of the products or technical data isto be described. Again you must be specific . Answeringvaguely or entering unknown is likely to delay the applicationprocess.


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JAPAN IMPORT REGULATIONS

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Pharmaceutical affairs law established by Ministry ofhealth and labour and welfare regulate the mattersnecessary for security, quality, efficacy and safety ofpharmaceuticals and medical devices.

Regulation at time of import Request of traders coderegistration Application of business licence formanufacture (import) and distribution ofpharmaceuticals.

Application of approval for items to be imported anddistributed Application of authorization as qualifiedforeign manufacture Application of GMP conformityexamination.


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Labelling :- The information must be printed ondirect container or direct package of medicine.Name, trade name, address of manufacture and

distribution licence Manufacturing mark ormanufacture no. Content quantity e.g. Volume,

weight storage condition, effective period and otherspecified matter, information Name of API

Expiration date of medicine . Word attention :habitual for medicine designated by MHRW ashabitual drugs.


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Japan remains the worlds No. 2 medical device market.

Japans market is highly regulated : Product approvalsare slow and expensive.

The Commerce Department helps U.S. Companiesovercome Japans regulatory problems.

Two Agencies Regulate Medical Devices in Japan:

Two agencies Regulate Medical Device in JapanPharmaceuticals and Medical Devices Agency (PMDA), orKiko Reviews product application is a government agencyneeds more device specialists as reviewers Ministry ofHealth, Labour and Welfare (MHLW) Approves productapplication is a government agency.


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I and E Licence Number

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IEC Code is a unique 10 digit code issued by DGFT-Director General of Foreign Trade Ministry ofCommerce, Government of India to Indian companies.

To import or export IEC code is mandatory. No person orentity shall make any import or export without IEC code

Number. An application for grant of IEC number shall be made by

the Registered/ head office of the applicant and apply tothe nearest Regional Authority of Directorate GeneralForeign Trade, the Registered office in case of company

and Head office in case of others, falls in the AayaatNiryaat Form ANF2A and shall be accompanied bydocuments prescribed therein.


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THE APPLICATION DULY SIGNED BY THE APPLICANT SHOULD BE

SUPPORTED BY THE FOLLOWING DOCUMENTS

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Bank receipt (in duplicate)/ demand draft for payment of thefee of Rs 1000. certificate from the Banker of the applicantfirm as per Annexure 1 to the form. Two copies of passportsize photograph of the applicant duly attested by the banker ofthe applicant.

A copy of Permanent Account Number issued by Income TaxAuthorities, if PAN has not been allotted a copy of the letter oflegal authority may be furnished. If there is any non residentinterest in the firm and NRI investment is to be made withrepatriable benefits, full particulars thereof along with aphotocopy of RBIs approval. If there is NRI investment

without repatriation benefit, a simple declaration indicatingwhether it is held with the general/ specific permission of theRBI on the letter head of the firm should be finished. In caseof specific approval a copy may also be furnished.


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Declaration by the applicant that the proprietors/partners/ directors of the applicant firm/ company theIEC No. Is allotted with a condition that be can exportonly with the prior approval of the RBI.

Profile of the exporter/ importer in a given format at

Appendix 3.111. The Registered office/ HO/ Branch office (dulyauthorized by the HO in this behalf) should apply forallotment of IEC No. However, only one IEC no. Isallotted to a company and the same is valid for all its

branches/ offices/ units. The application for the grantof IEC no. Should be made to specified in Appendix3.111.


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1. The application fee shall be deposited by way ofdeposit in an authorized branch of Central Bank ofIndia indicating the head account 1453 ForeignTrade and Export Promotion minor head 102import licence application fee.

2. The IEC no. Is likely to be granted within 3 days ofthe receipt of the complete application and

requisite documents.

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How to fill up IEC application

Application form should be made in theprescribed from in duplicate along with the aboveenclosures.

1. The form should be neatly typed/ hand written inbold capital letters only.

2. Each copy of the application from should be

signed in ink by the authorised person.3. Items of information relevant to applicant shouldonly be filled and remaining items may bemarked not applicable.


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1. Modification of particulars of the applicant shouldalso be furnished on this form by filling therelevant items.

2.However, in case an IEC holder no longer wishes tooperate under the allotted code number, the mattershould be brought under the notice of RegionalLicensing Authority to make the code number

inoperative.

cont.

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cont.

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EUROPE EXPORT REGULTIONS

The MHRA on the behalf of the department of Health,issues export certificate on request to assist exporter ofmedicinal product to satisfy the import requirement ofother country.

The certificate issued by MHRA where necessary, theformat of certificate complies with that specified byinternational authorities, e.g WHO.

The MHRA issues four different type of certificates, twoof which comply with the format establish by the WHO.

Each type of certificate is country specific , naming oneindividual country .

CERTIFICATE FOR PHARMACEUTICAL


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CERTIFICATE FOR PHARMACEUTICALPRODUCT

This certificate complies with the format specified byWHO.

The certificate will provide details about a single

named medicinal product which may be licensed orunlicensed in the U.K.

It provide details about the product:

1. The active ingredients and excipients,

2. The manufacturing and packaging sites

3. Whether or not the product is placed on the marketin U.K.

cont.

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CERTIFICATE OF LICENSING STATUS

This certificate complies with the format specified by theWHO.

It is intended for use by importing agents who are requiredto screen bids made in response to an international tender

and can apply to licensed or unlicensed product. The certificate of licensing status is limited to ten product

per certificate and country specific.

Details of the product name, dosage form, active

ingredients and amount should all be quotes in accordancewith their product license ( if applicable ) and these detailswill be checked against the MHRA.

cont.

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CERTIFICATE OF MANUFACTURING STATUS


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CERTIFICATE OF MANUFACTURING STATUS( CMS)

It dose not provide any product specified information, butit confirms whether named sites meet Good ManufacturingPractice requirements on a specified manufacturing licensenumber.

All or any of the sites named on the manufacturing licensemay be listed on the certificate.

Certificate for the importation of a pharmaceuticalconstituent ( CPC) is available for a named constituent of

medicinal product. The MHRA will only issue certificate for unlicensed

medicinal product that are manufactured in the U.K on asite holding a manufacturers license appropriate to the

dosage form of product which the certificate appliescont.

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It is not possible to issue a certificate for unlicensedproduct manufactured outside the U.K.

THE CERTIFICATE OF A PHARMACEUTICALPRODUCT

It requires the most detailed information.

All forms ask for date of application, your reference,your name and business name and address, invoice

details if different form the applicants name ofimporting country, standard or urgent service,language and number of copies required.

cont.

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IMPORT REGULATION OF EU47

Documents

exim requlations