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Premium member Presentation Transcript Export and import regulations and methods to obtain licence for export and import of pharmaceuticals as per India , U.S., EU, Japan: SUBMITTED BY :- Alok kr vishwakarma Mahendra singh Amit verma Dept. of pharmaceutics Psit,kanpur cont. 1 Export and import regulations and methods to obtain licence for export and import of pharmaceuticals as per India , U.S., EU, JapanINTRODUCTION: INTRODUCTION cont. 2 Export is selling the drugs, pharmaceuticals, medical devices etc. To other countries crossing the geographical frontiers of the country. Import is purchases drugs from other country and brings them in to the country crossing the geographical borders of the country.General procedure for export: General procedure for export cont. 3 Steps of export procedures :- Receipt of indent Receipt of license for export procurement of goods. Packaging and labelling appointment of forwarding agent dispatch of goods. Foreign customs permit shipping order export duty and shipment bill, Dock dues or challan loading the Mate’s receipt. Bill of loading Marine insurance forwarding agent advice. Preparation of export invoice Payment Advice to importer.General procedure for import: General procedure for import cont. 4 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 deliveryImport regulation in India: Import regulation in India cont. 5 Forms Form 10 - import drugs excluding those specified in schedule X. Form 10A - import drugs specified in schedule X. Registration certificate Certificate issued under rule 27 a by licensing authority in form 41 for registration of premises and drugs manufactured by manufacturer meant for import in to and use in India.Slide 6: cont. 6 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 and reagents. For duplicate license (if original is damaged or lost) 250 Rs shall be paid.Slide 7: cont. 7 A single application be made and a single license may be issued in respect of import of more than one drugs manufactured by same manufacturer. Conditions of import licence :- Premises where imported substance will be stocked are equipped with proper storage. The licensee shall allow any inspector authorized by licensing authority in that behalf to enter with or without notice . Any premises where the imported substance is stocked to inspect the means any employed can come for testing substance and to take sample. Licensee shall being informed by the licensing authority that any part of batch of substance has been found not to confirm with standards of strength , quality, purity.Slide 8: cont. 8 Licensee shall maintain the records of all sales by him of substances for which a license is required. Licensee should maintain a records of all particulars for schedule X drugs. Grant of license License is valid for a period of three years. Prohibition of import after expiry of potency Standards of certain imported drugs. Licensing authority shall not import of any drug having less than 60% residual shelf life period as on date of import. Packaging and labelling should be in conformity with the rules.Medical Device: Medical Device cont. 9 The ministry of Health and Family welfare under Gazette notification S.O. 1468 (E) dated 6/10/05 declared the following sterile devices to be considered as drug under Section 3 (b) (iv) of the Act . Cardiac Stents 2. Drug Eluting Stents 3. Catheters 4. Intraocular Lenses 5. I.V. Cannula 6. Bone cements 7. Heart Valves 8. Scalp vein set 9. Orthopedic Implant 10. internal Prosthetic replacements.Import Of Medical Devices: Import Of Medical Devices cont. 10 Procedure for registration and import licence as prescribed under the D&C rules shall be followed. A period of 60 days would be provided for the importers to make application for import and registration from the date of publication of these guidelines. In case of device which have not been imported in the country before the date of notification no import would be permitted without the approval of the competent authority.Slide 11: cont. 11 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 be sold. Separate committees consisting of subject expert and representative would be setup for their expert advice for evaluation of specific categories of devices. Expert committees would formulate their own procedure for evaluation and the standards to which device should conform.Export regulation of India: Export regulation of India cont. 12 It was compulsory for every exporter to obtain an exporter’s code number from the RESERVE BANK OF INDIA 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 valid IEC number. For obtaing IEC no. you should apply to Regional Licensing authority in duplicate.Slide 13: cont. 13 Before applying for IEC no. it is necessary to open bank account in 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 document : Bank receipt ( in duplicate). Demand draft for payment of the fee of Rs. 1000/- Two copies of pasport size photographs of the applicant duly attested by the banker to the applicants.Slide 14: cont. 14 A copy of permanent account no. issued by Income Tax Authority. If PAN has not been allotted, a copy of application of PAN submitted to Income Tax Authority. An IEC no. allotted to an applicant shall be valid for all its branches/ divisions as indicated on the IEC no.. Application for grant of export license in respect of items mentioned in schedule 2 of ITC (HS). Classification of export and import items may be made in the form given in appendix 18A or 18B or 18C. Compulsory quality control and pre-shipment inspection : Compulsory quality control and pre-shipment inspection cont. 15 An important aspect about the goods to be exported is compulsory quality control and pre-shipment inspection. Under the export act 1963 pharmaceutical product are subject to compulsory pre-shipment inspection. At times , foreign buyers lay down their own standards/ Specification which may or may not be in consonance agencies. .IN PROCESS QUALITY CONTROL: IN PROCESS QUALITY CONTROL cont. 16 The inspection is done at various stages of production. The export 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 form time to time. The certificate of inspection on the end-product is then given without in-depth study at the shipment stage.Slide 17: cont. 17 Under this system, export is allowed on the adequacy of in-process quality control and inspection measures exercised by the manufactured units themselves. The certificates of inspection in favor of the units approved under the scheme are issued by the Export Inspection Agencies in the normal course.Labeling, packaging, and marking goods: Labeling, packaging, and marking goods cont. 18 The involves labeling, packaging, packing and marking of export consignments. Labeling requirement differ form country to country and the same should be ascertained well in advance form the buyer. The label should indicate quality, quantity, method of use etc. Packaging should also be in conformity with the instruction issued by the importer.U.S. IMPORT REQUIREMENTS: U.S. IMPORT REQUIREMENTS cont. 19 CONTENTS Import requirements. Arrival of goods. Entry of goods. Other types of entry Customs examination of goods. Protest. Mail shipments. Restricted Merchandise Foreign assets controlU.S. IMPORT REQUIREMENTS: U.S. IMPORT REQUIREMENTS cont. 20 An individual may make his own customs clearance of goods imported for personal use or business. All merchandise coming into the United States must clear customs and is subjected to a customers duty unless specifically exempted by law clearance involves a no. of steps- Entry, Inspection, Appraisement, Classification and liquidation. The U.S. Customs service does not require an importer to have license or permit. The importer must declare the dutiable value of merchandise. The importer must determination the classification no. of the merchandise imported.Slide 21: cont. 21 The dutiable value of merchandise is determined by customs. Several appraisal methods are used to arrive at this value. The Harmonized Tariff Schedule of the United States (HTSUS), issued by International Trade Commission, prescribes the rates of duty and classification of merchandise 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 lower than the rates currently accorded most favoured nations) and “ column 2” rates for imports not eligible for either general or special rates.ARRIVAL OF GOODS: ARRIVAL OF GOODS cont. 22 Imported goods may not be entered legally until the shipment has arrived within the limits of the port of entry and delivery of the merchandise has been authorized by customs. The is normally accomplished by filling the appropriate documents either by importer or by importer’s agent. Imported merchandise not entered through customs in a timely manner (up to 30 days) is sent by customs to a general order warehouse to be held as unclaimed.ENTRY OF GOODS: ENTRY OF GOODS cont. 23 To make or file a customs entry, the following documents are generally required: A bill of lading, airway bill or carrier’s certificate (naming the consignee for customs purposes) as evidence of the consignee’s right to make entry. A commercial invoice ,obtained from the seller, which shows the value and description of the merchandise. Entry manifest (Customs Form 7533) or Entry / Immediate Delivery (Customs Form 3461). Packing lists, if appropriate and other documents necessary to determine whether the merchandise may be admitted.OTHER TYPES OF ENTRY: OTHER TYPES OF ENTRY cont. 24 IMPORTED GOODS MAY BE SENT IN-BOND FROM THE FIRST PORT OF ARRIVAL TO ANOTHER CUSTOMS PORT. Arrangements for in-bond shipments should be made before the goods leave the country of export. In- bond entries postpone final customs formalities, including payment of duty and processing fee, until the goods arrive at the final port.CUSTOMS EXAMINATION OF GOODS: CUSTOMS EXAMINATION OF GOODS cont. 25 Examination of goods is necessary to determine: The value of the goods for customs purposes and their dutiable status. Whether the goods must be marked with the country of their origin or with special marking or labelling. Whether the shipment contains prohibited articles. Whether requirements of other federal agencies have been met. Whether goods excess of the invoiced quantities are present or a shortage of goods exists.PROTEST: PROTEST cont. 26 With in 90 days, after the date of liquidation or other decision, an importer or consignee may protest the decision and receive an administrative review. The protest is filled with the port director where decision is being protested. Any person whose protest has been denied may content the denial by filing a civil action in the U.S. Court of inter trade.MAIL SHIPMENTS: MAIL SHIPMENTS cont. 27 Shipments by mail which do not exceed $2000 in value whether commercial and non commercial importations are entered under mail entry prepared by a customs officer after the postal service submits.EXPORT REGULATIONS: EXPORT REGULATIONS cont. 28 The Export Administration Regulations (EAR) regulate the export and re-export of the items for national security, non proliferation, foreign policy, and short supply reasons. The Department of Commerce’s Bureau of Export administration (BXA) has taken important steps to remove unnecessary obstacles to exporting, including completion of U.S. Regulatory reform effort and export control liberalization license.APPLY FOR LICENSE: APPLY FOR LICENSE cont. 29 If an export license is required, you must prepare a Form BXA- 748P, “Multipurpose Application Form” and submit it to BXA. The form can be used for requesting an export license, re-exports or commodity classification.MEDICAL DEVICE REGULATION OF U.S.: MEDICAL DEVICE REGULATION OF U.S. cont. 30 Any medical device that is legally in the U.S. may be exported anywhere in the world without prior FDA notification 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- The manufacturing facility must be registered with FDA. The device must be listed with FDA. Device must have cleared premarket notification 510(k) or premarket approval. Device must meet labelling requirment of 21CFR part 801 and 21 CFR 809, if applicable.IMPORT MEDICAL DEVICE : IMPORT MEDICAL DEVICE cont. 31 I n order to import medical device into U.S., the product must meet FDA regulatory requirements. FDA dose not recognize regulatory approval from other countries foreign manufacturers must meet applicable United states medical device regulations in order to import device into U.S. even if the product is authorized for marketing in another country. These order include: Listing of device Manufacturing in accordance with the quality system Medical device reporting adverse effect Premarket notification or premarket approval entry information should identify the product and include appropriate information to demonstrate product compliance with FDA . Product information should include product name and product code.AVOIDING DELAY IN RECEIVING A LICENSE: AVOIDING DELAY IN RECEIVING A LICENSE cont. 32 In filling out a license application, re-exporters commonly make four errors that account for most delays in processing applications: Failing to sign the application. Handwriting, rather than typing the application. Responding inadequately to section 22(j) of the application, “Description of Commodity or Technical Data”, which calls for a description of the item or items to be exported. You must be specific, and you are encouraged to attach additional material to explain the product fully. Responding inadequately to section 21 of the application, where the specific end use of the products or technical data is to be described. Again you must be specific . Answering vaguely or entering “unknown” is likely to delay the application process .JAPAN IMPORT REGULATIONS: JAPAN IMPORT REGULATIONS cont. 33 Pharmaceutical affairs law established by Ministry of health and labour and welfare regulate the matters necessary for security, quality, efficacy and safety of pharmaceuticals and medical devices. Regulation at time of import Request of trader’s code registration Application of business licence for manufacture (import) and distribution of pharmaceuticals. Application of approval for items to be imported and distributed Application of authorization as qualified foreign manufacture Application of GMP conformity examination.Slide 34: cont. 34 Labelling :- The information must be printed on direct container or direct package of medicine. Name, trade name, address of manufacture and distribution licence Manufacturing mark or manufacture no. Content quantity e.g. Volume, weight storage condition, effective period and other specified matter, information Name of API Expiration date of medicine . Word “attention ” : habitual for medicine designated by MHRW as habitual drugs.Slide 35: cont. 35 Japan remains the world’s No. 2 medical device market. Japan’s market is highly regulated : Product approvals are slow and expensive. The Commerce Department helps U.S. Companies overcome Japan’s regulatory problems. Two Agencies Regulate Medical Devices in Japan: Two agencies Regulate Medical Device in Japan Pharmaceuticals and Medical Devices Agency (PMDA), or Kiko Reviews product application is a government agency needs more device specialists as reviewers Ministry of Health, Labour and Welfare (MHLW) Approves product application is a government agency.I and E Licence Number: I and E Licence Number cont. 36 IEC Code is a unique 10 digit code issued by DGFT- Director General of Foreign Trade Ministry of Commerce, Government of India to Indian companies. To import or export IEC code is mandatory. No person or entity 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 to the nearest Regional Authority of Directorate General Foreign Trade, the Registered office in case of company and Head office in case of others, falls in the “Aayaat Niryaat Form – ANF2A” and shall be accompanied by documents prescribed therein. THE APPLICATION DULY SIGNED BY THE APPLICANT SHOULD BE SUPPORTED BY THE FOLLOWING DOCUMENTS: THE APPLICATION DULY SIGNED BY THE APPLICANT SHOULD BE SUPPORTED BY THE FOLLOWING DOCUMENTS cont. 37 Bank receipt (in duplicate)/ demand draft for payment of the fee of Rs 1000. certificate from the Banker of the applicant firm as per Annexure 1 to the form. Two copies of passport size photograph of the applicant duly attested by the banker of the applicant. A copy of Permanent Account Number issued by Income Tax Authorities, if PAN has not been allotted a copy of the letter of legal authority may be furnished. If there is any non resident interest in the firm and NRI investment is to be made with repatriable benefits, full particulars thereof along with a photocopy of RBI’s approval. If there is NRI investment without repatriation benefit, a simple declaration indicating whether it is held with the general/ specific permission of the RBI on the letter head of the firm should be finished. In case of specific approval a copy may also be furnished.Slide 38: cont. 38 Declaration by the applicant that the proprietors/ partners/ directors of the applicant firm/ company the IEC No. Is allotted with a condition that be can export only with the prior approval of the RBI. Profile of the exporter/ importer in a given format at Appendix 3.11 The Registered office/ HO/ Branch office (duly authorized by the HO in this behalf) should apply for allotment of IEC No. However, only one IEC no. Is allotted to a company and the same is valid for all its branches/ offices/ units. The application for the grant of IEC no. Should be made to specified in Appendix 3.111.Slide 39: The application fee shall be deposited by way of deposit in an authorized branch of Central Bank of India indicating the head account 1453 Foreign Trade and Export Promotion minor head 102 import licence application fee. The IEC no. Is likely to be granted within 3 days of the receipt of the complete application and requisite documents. cont. 39Slide 40: cont. 40 How to fill up IEC application Application form should be made in the prescribed from in duplicate along with the above enclosures. The form should be neatly typed/ hand written in bold capital letters only. Each copy of the application from should be signed in ink by the authorised person. Items of information relevant to applicant should only be filled and remaining items may be marked not applicable.Slide 41: Modification of particulars of the applicant should also be furnished on this form by filling the relevant items. However, in case an IEC holder no longer wishes to operate under the allotted code number, the matter should be brought under the notice of Regional Licensing Authority to make the code number inoperative. cont. 41Slide 42: cont. 42 EUROPE EXPORT REGULTIONS The MHRA on the behalf of the department of Health, issues export certificate on request to assist exporter of medicinal product to satisfy the import requirement of other country. The certificate issued by MHRA where necessary, the format of certificate complies with that specified by international authorities, e.g WHO. The MHRA issues four different type of certificates, two of which comply with the format establish by the WHO. Each type of certificate is country specific , naming one individual country .CERTIFICATE FOR PHARMACEUTICAL PRODUCT : CERTIFICATE FOR PHARMACEUTICAL PRODUCT This certificate complies with the format specified by WHO. The certificate will provide details about a single named medicinal product which may be licensed or unlicensed in the U.K. It provide details about the product: The active ingredients and excipients, The manufacturing and packaging sites Whether or not the product is placed on the market in U.K. cont. 43CERTIFICATE OF LICENSING STATUS: CERTIFICATE OF LICENSING STATUS This certificate complies with the format specified by the WHO. It is intended for use by importing agents who are required to 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 accordance with their product license ( if applicable ) and these details will be checked against the MHRA. cont. 44CERTIFICATE OF MANUFACTURING STATUS ( CMS): CERTIFICATE OF MANUFACTURING STATUS ( CMS) It dose not provide any product specified information, but it confirms whether named sites meet Good Manufacturing Practice requirements on a specified manufacturing license number. All or any of the sites named on the manufacturing license may be listed on the certificate. Certificate for the importation of a pharmaceutical constituent ( 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 a site holding a manufacturer’s license appropriate to the dosage form of product which the certificate applies cont. 45Slide 46: It is not possible to issue a certificate for unlicensed product manufactured outside the U.K. THE CERTIFICATE OF A PHARMACEUTICAL PRODUCT – 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 applicant’s name of importing country, standard or urgent service, language and number of copies required. cont. 46IMPORT REGULATION OF EU: IMPORT REGULATION OF EU cont. 47 You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.