SAMPLE AND IMPORTANCE OF EXPORT DOCUMENT FOR A PHARMA PRODUCT

EXPORT:-

IMPORT:-

VINIT SHAH

MBA PHARMA SEM-II

K.B.I.P.E.R.

TABLE OF CONTENTS

Introduction Export general procedures India export regulations Conclusion References

INTRODUCTION

Export :Export is selling the drugs ,pharmaceuticals, medical devices etc. to other countries crossing the geographical frontiers of the country. A good example is India selling the drugs to U.S.A and England. Export earns a country lot of foreign exchange and helps in tilting the balance of payment.

INDIAN PHARMACEUTICAL INDUSTRY : EXPORT

2008-2009 30730 2008-2009 2007-2008 2006-2007 2005-2006 2004-2005 2003-2004 2002-2003 38433

2007-2008 2006-2007 24942

2005-2006

22216

2004-2005 2003-2004

17857

15213

2002-2003

12826

Figures in Rs Crore

GENERAL PROCEDURE FOR EXPORT

The export procedure includes several steps :1. Receipt of indent 2. Receipt of license for export 3. Procurement of goods. 4. Packing and labeling 5. Appointment of forwarding agent 6. Dispatch of goods. 7. Foreign customs permit 8. Shipping order 9. Export duty and shipment bill 10. Dock dues or challan 11. Loading the goods 12. Mates receipt

GENERAL PROCEDURE FOR EXPORT CONT.

13. 14. 15. 16. 17. 18.

Bill of loading Marine insurance Forwarding agent advice Preparation of export invoice Payment Advice to importer

EXPORT REGULATIONS OF INDIA

Registration
It was compulsory for every exporter to obtain an exporters' code number from the Reserve Bank of India before engaging in export. Registration with Regional Licensing: Authorities (obtaining IEC Code Number) The Customs Authorities will not allow you to import or export goods into or from India unless you hold a valid IEC number. For obtaining IEC number you should apply to Regional Licensing Authority in duplicate . Before applying for IEC number it is necessary to open a bank account in the name of your company / firm with any commercial bank authorized to deal in foreign exchange. The duly signed application form should be supported by the following documents: Bank Receipt (in duplicates)/Demand Draft for payment of the fee of Rs. 1,000/-.

CONT.

Two copies of Passport size photographs of the applicant duly attested by the banker to the applicants. A copy of Permanent Account Number issued by Income Tax Authorities. If PAN has not been allotted, a copy of application of PAN submitted to Income Tax Authorities

The number should normally be given within 3 days provided the application is complete in all respects and is accompanied by the prescribed documents.

An IEC number allotted to an applicant shall be valid for all its branches/divisions as indicated on the IEC number

CONT..

Acquire Export License

Exports free unless regulated: The current Export Licensing Policy of the Government of India is contained in the new Import Export Policy and Procedures, 1997-2002 as amended .

It may be stated that all goods may be exported without any restriction except to the extent such exports are regulated by the ITC (HS) Classifications of Export and Import items

Application for an Export License:

An application for grant of export license in respect of items mentioned in Schedule 2 of ITC (HS) Classifications of Export and Import items may be made in the form given in Appendix-18A or 18B or 18C.

Compulsory Quality Control & Preshipment Inspection

An important aspect about the goods to be exported is compulsory quality control and pre-shipment inspection. Under the Export(Quality Control and Inspection) Act, 1963 pharmaceutical products are subject to compulsory pre-shipment inspection. At times, foreign buyers lay down their own standards / specifications which may or may not be in consonance with the Indian standards. They may also insist upon inspection by their own nominated agencies. These issues should be sorted out before confirmation of order.

Particulars of the consignment intended to be exported. A crossed cheque/draft for the amount of requisite inspection fees or an Indian Postal Order.

Copy of the Commercial Invoice. Copy of letter of credit. Details of packing specifications. Copy of the export order/contract, indicating that products are strictly according to the prescribed specifications

The certificate is issued in the standardised form which is aligned pre-shipment export document. (Three copies for exporter, original copy for customs use, the second copy for the use of the foreign buyer and the third copy for the exporter's use, fourth copy for Data Bank, Export Inspection Council, New Delhi and the fifth copy is retained with the agency for their own office record).

In-Process Quality Control (IPQC)

The inspection is done at various stages of production. The exporter has to get his unit registered as "Export Worthy" and keep record of processing and production. Inspection by the officers of Export Inspection Agency is done from time to time. The certification of inspection on the end-products is then given without in-depth study at the shipment stage. Under this system, export is allowed on the basis of adequacy of in-process quality control and inspection measures exercised by the manufacturing units themselves. The certificates of inspection in favor of the units approved under the scheme are issued by the Export Inspection Agencies (EIAs) in the normal course.

Labeling, Packaging, Packing and Marking Goods This involves labeling, packaging, packing and marking of export consignments. Labeling requirements differ from country to country and the same should be ascertained well in advance from the buyer.

The label should indicate quality, quantity, method of use etc. packaging should also be in conformity with the instructions issued by the importer. Packing refers to the external containers used for transportation .

All shipping cases should be marked a number with special symbols selected by the exporters or the importers, so that the competitors cannot find out the details of the customers and the country of destination or supplier's country of despatch. Care should also be taken to ensure that the marking conforms to those written in the invoice, insurance certificate, bill of lading and other documents.

ATTACHMENTS FORMS:

Attachments: Model Certificate to Foreign Government Model Certificate of Exportability - Section 802 Model Certificate of Exportability - Section 801(e)

CERTIFICATE TO FOREIGN GOVERNMENT

In order to allow the importation of United States products into foreign countries, the U.S. Food and Drug Administration (FDA) certifies the following information concerning the product(s) to be exported listed below: NAME OF MANUFACTURER OR DISTRIBUTER, ADDRESS NAME OF PRODUCT(S) (GENERIC NAME IF APPLICABLE) COUNTRY OF DESTINATION (OPTIONAL) PREMARKET APPROVAL IDENTIFIER (IF APPLICABLE, I.E., NDA, NADA, PMA NUMBER, 510(k) NUMBER, LICENSE NUMBER) The product(s) described above and the plant(s) where it is produced are subject to the jurisdiction of the FDA under the Federal Food, Drug, and Cosmetic Act. It is certified that the above listed product(s) may be marketed in, and legally exported from, the United States of America at this time. The manufacturing plant(s) in which the product(s) is produced is subject to periodic inspections. The last such inspection showed that the plant(s), at that time, appeared to be in substantial compliance with current good manufacturing practice requirements for the product(s) listed above. _____________________________ Signature _____________________________ Title Food and Drug Administration _____________________________ Date This certificate expires on (insert - date 24 months from date notarized). County of ________________ State of _________________ Subscribed and sworn to before me this _____ day of _________. Notary Public ________________________ My Commission Expires __________________________________ Certificate No.

CERTIFICATE OF EXPORTABILITY (SECTION 802)

The Food and Drug Administration certifies that the product(s) described below is subject to its jurisdiction under the Federal Food, Drug, and Cosmetic Act (the Act). Such product(s), which is not approved for marketing in the United States, may be legally exported provided it meets the requirements of Section 802 of the Act. Under Section 802 of the Act, a drug or device not approved for marketing in the United States may be exported if it is manufactured, processed, packaged, and held in substantial conformity with current good manufacturing practice requirements. The manufacturing plant(s) in which the product(s) is produced is subject to periodic inspections. The last such inspection showed that the plant(s), at that time, appeared to be in substantial compliance with current good manufacturing practice requirements for the product(s) listed below. The company has certified to the Food and Drug Administration that: * The product(s) accords to the specifications of the foreign purchaser; * The product(s) is not in conflict with the laws of the country to which it is intended for export; * The shipping package for the product(s) is labeled on the outside that it is intended for export; and * The product(s) is not sold or offered for sale in the United States. Based on the information above, the product(s) listed below may be exported pursuant to Section 802 of the Act. NAME OF PRODUCT [NAME OF COMPANY], [ADDRESS] (GENERIC NAME IF APPLICABLE) COUNTRY OF DESTINATION (OPTIONAL) ______________________________ Signature _______________________________ Title Food and Drug Administration ________________________________ Date This certificate expires on (insert - date 24 months from date notarized). County of ___________________ State of ___________________ Subscribed and sworn to before me this ______ day of __________. Notary Public ________________________ My Commission Expires _________________________ Certificate No.

CERTIFICATE OF EXPORTABILITY (SECTION 801(E)) Drug Administration certifies that the product(s) described below is subject to its jurisdiction under the Federal The Food and

Food, Drug, and Cosmetic Act (the Act). The product(s) described below may not be sold or offered for sale in the United States. The company has certified to the Food and Drug Administration that: * The product(s) accords to the specifications of the foreign purchaser; * The product(s) is not in conflict with the laws of the country to which it is intended for export; * The shipping package for the product(s) is labeled on the outside that it is intended for export; and * The product(s) is not sold or offered for sale in the United States. Based on the information above, the product(s) listed below may be exported pursuant to Section 801(e) of the Act. NAME OF PRODUCT [NAME OF COMPANY], [ADDRESS] (GENERIC NAME IF APPLICABLE) COUNTRY OF DESTINATION (OPTIONAL) ___________________________ Signature _____________________________ Title Food and Drug Administration _____________________________ Date This certificate expires on (insert - date 24 months from date notarized). County of __________________________ State of ____________________________ Subscribed and sworn to before me this ______ day of _________. Notary Public ______________________________ My Commission ExGuidance for Industry1 FDA Export Certificates

CONCLUSION:

Export Documentation plays a vital role in international business, as it facilitates the smooth flow of goods and payments there of across national frontiers. A number of documents accompany every shipment. These documents must be properly and correctly filled.

REFERENCES

http://trade.gov/index.asp http://trade.gov/mac/index.asp http://trade.gov/cs/index.asp http://trade.gov/mas/index.asp http://www.mhlw.go.jp/english http://www.pmda.go.jp/english/index.html http://www.fda.gov/cdrh/devadvice/39.html http://www.fda.gov/cder/guidance/pharmCert2002.pdf http://pharmaceuticals.gov.in/ www.wwcf.com.au. http://www.indiainbusiness.nic.in/industry-infrastructure/industrial-sectors/drugpharma.htm