import and export of pharmaceuticals corrt

Export and import regulations and methods to obtain licence for export and import of pharmaceuticals as per u.s,eu,japan presented by: priyanka nagar m pharm(2 sem) : 

EXPORT:- IMPORT:- Export and import regulations and methods to obtain licence for export and import of pharmaceuticals as per u.s,eu,japan presented by: priyanka nagar m pharm(2 sem)

Table of contents : 

Table of contents Introduction Export and import general procedures India export and import regulations U.s export and import regulations Europe export and import regulations Japan export and import regulations References

introduction : 

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. Import :- When a country purchases drugs from other country and brings them in to the country crossing the geographical borders of the country it is called import.

Indian Pharmaceutical Industry : 

Indian Pharmaceutical Industry Indian Pharmaceutical Market ~US $ 20 bn Import (2008-09 ) US$ 2.7 Bn Export (2008-09 ) US$ 8.6 Bn 8% global Production & 2% of World pharma Market Bulk Drug Production > 400 API’s Export of Biotech products & Biopharmaceuticals ~US $1363M Manufacturing Facilities 142 US FDA Approved Largest Number of Manufacturing Facilities outside US Abbreviated New Drug approval Filing - 2nd to USA

Indian Pharmaceutical IIndustry: EXPORTS : 

Indian Pharmaceutical IIndustry: EXPORTS

General procedure for export : 

General procedure for export The export procedure includes several steps :- Receipt of indent Receipt of license for export Procurement of goods. Packing and labeling Appointment of forwarding agent Dispatch of goods. Foreign customs permit Shipping order Export duty and shipment bill Dock dues or challan Loading the goods Mate’s receipt

General procedure for export cont. : 

General procedure for export cont. Bill of loading Marine insurance Forwarding agent advice Preparation of export invoice Payment Advice to importer

Import general procedure : 

Import general procedure Obtaining import licence Foreign exchange Placing the indent Dispatch of goods by export agent Obtaining shipment documents 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

IMPORT REGULATIONS IN INDIA : 

IMPORT REGULATIONS IN INDIA IMPORT LICENCE:- Licence in form 10 is to import drugs excluding those specified in schedule X Licence in form 10-A to import drugs specified in schedule X Registration certificate:- means a 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. Forms and manner of application for import licence:- An application for an import licence shall be made to the licensing authority in form 8 for drugs excluding those specified in schedule X Form 8-A for drugs specified in schedule X Fee for licence:- 1000Rs for a single drug and additional fee at rate of 100Rs for each additional drug.

IMPORT REGULATIONS IN INDIA CONT. : 

IMPORT REGULATIONS IN INDIA CONT. Application for import licence shall be accompanied by a copy of registration certificate. Registration certificate shall not be required for import of invitro diagnostic kits and reagents. A fee of 250Rs shall be paid for a duplicate copy of license issued if original is damaged or lost. A single application be made and a single license may be issued in respect of import of more than one drug or class of 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 substances is stocked to inspect the means if any employed for testing substance and to take sample.

Cont.. : 

Cont.. Licensee shall being informed by the licensing authority that any part of any batch of substance has been found not to confirm with standards of strength,quality,purity. Licensee shall maintain the records of all sales by him of substances for import of which a license is required.

CONT. : 

CONT. Licensee shall maintain the records of all particulars for schedule X drugs Name of the drug Batch number Name of address of manufacture Date of transaction Opening stock on business day Quantity of drugs received if any and the source Name of purchaser, his address and licence no. Balance quantity of drug at end of business day Signature of person under whose supervision drug supplied.

CONT.. : 

CONT.. Grant of license:- The licensing authority issue the license AND IS VALID FOR A PERIOD OF THREE YEARS. If manufacturer fail to comply with any of the condition of import licence the licensing authority may after giving an opportunity to show the cause why such an order should not passed by an order in writing stating reason suspend it. 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 labeling should be in conformity with the rules.

MEDICAL DEVICE : 

MEDICAL DEVICE The Ministry of Health and F.W. under Gazette notification S.O. 1468 (E) dated 6/10/2005 declared the following sterile devices to be considered as drugs under Section 3 (b) (iv) of the Act. 1.      Cardiac Stents. 2.      Drug Eluting Stents. 3.      Catheters. 4.      Intra Ocular Lenses. 5.      I.V. Cannula. 6.      Bone Cements. 7.      Heart Valves. 8.      Scalp Vein Set. 9.      Orthopedic Implants. 10.  Internal Prosthetic replacements.

Cont. : 

Cont. IMPORT OF MEDICAL DEVICES For the purpose of import of Devices specified above, the procedure for registration and import licence as prescribed under the Drugs and Cosmetics Rules shall be followed. 1.  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. 2.  In case of devices 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.

Cont.. : 

Cont.. 3. For the time being and for a period up to six months, until an application is approved or rejected, whichever is earlier, the devices which are currently in use will be permitted to be sold. In case of stents or drug eluting stents the import will not be permitted if the applicant has sold less than One thousand stents of the particular specification prior to the date of issue of these guidelines.  4.  Separate committees consisting of subject experts and representative of DCG(I) office would be setup for their expert advice for evaluation of specific categories of devices. The expert committees would formulate their own benchmarks and procedures for evaluations and the standards to which such devices should conform.

Export regulations of india : 

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. : 

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.. : 

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

Slide 20: 

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.

Slide 22: 

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.

Slide 23: 

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).

Slide 24: 

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.

Slide 25: 

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.

EXPORT REGULATIONS OF U.S.A BY FDA : 

EXPORT REGULATIONS OF U.S.A BY FDA The export of drug,,biologicals,device etc. from U.S is governed by the FDA Export reform act 1906 under section 801 and 802 of the act. This act is then amended in 1986 and FDA Export reform and enhancement act 1996 which basically solves the problem for exporting of unapproved drugs biologicals and devices. Certification for Exports:- Certification is the process by which a formal or official attestation is made concerning the regulatory status of a product.

Cont. : 

Cont. Requests for certification have variously asked for verification that the products being exported: (1) are freely marketed in the U.S.; (2) are in compliance with U.S. laws and regulations; (3) are in compliance with the importing country's requirements; (4) meet certain national or international standards, such as quality standards; or (5) do not contain specific contaminants. FDA has historically issued a number of different types of certificates, e.g., Certificates of Free Sale, Certificates for Export, Certificates to Foreign Governments

CONT.. : 

CONT.. Under section 801(e) of the Act, FDA is required to issue certificates for human drugs and biologics, and devices that meet the applicable requirements of the Act. If FDA issues a certificate within 20 days of receipt of a request for such a certificate, the agency may charge a fee of up to $175. The following guidance has been developed to improve agency uniformity and consistency in providing export certificates: Certificates for human drug products, including human biological drugs, that conform to the World Health Organization’s certification requirements should be entitled . If authentication of the certificate is required, the certificate may be notarized or certified under seal of the Department of Health and Human Services in accordance with 21 CFR 5.22, or both.

Cont.. : 

Cont.. a. Provide a written statement that: (1) identifies the product or products to be exported; and (2) demonstrates that the products to be exported-- 5. A certification issued pursuant to section 801(e) of the Act may contain the following elements (specific examples are attached): a. A statement that each specific product identified is subject to FDA jurisdiction b. A statement indicating the compliance status of the system by which the product is required to be manufactured for approved or licensed products

Cont… : 

Cont… A statement that the certificate is valid for a period of twenty-four (24) months from the date authorized Examples of circumstances for which certificates would not be issued include: Failure of the manufacturing facilities to operate in compliance with the current Good Manufacturing Practice regulations Manufacturing facility not registered or listed with FDA. Manufacturing facility for which FDA has no inspectional information. Products eligible for a certification of exportability if they meet the applicable requirements of sections 801 and 802 of the act.

Cont… : 

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

CERTIFICATE TO FOREIGN GOVERNMENT : 

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_____________________________TitleFood 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) : 

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 _______________________________TitleFood 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)) : 

Certificate of Exportability (Section 801(e)) 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). 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_____________________________TitleFood 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 Industry1FDA Export Certificates

Import regulations of U.S : 

Import regulations of U.S Imported products regulated by the FDA are subject to inspection at the time of entry by the U.S. Bureau of Customs & Border Protection (Customs).  Shipments not found to comply with the law are subject to detention.  They must be brought into compliance, destroyed, or re-exported.  Under the Act, FDA may refuse admission to any drug that "appears" to be unapproved, misbranded, or adulterated, placing the burden on the importer to prove that specific drugs sought to be imported are not in violation of the Act.

Cont. : 

Cont. FDA's Import Program / General Procedures Entry of Product into the United States To ensure that FDA is notified of all regulated products imported into the United States, the importer, or his/her representative, must file an entry notice and an entry bond with Customs pending a decision regarding the admissibility of the product.  FDA inspection and enforcement procedures for imports rely on coordination with Customs.  FDA is notified by Customs of the product’s entry and makes a decision as to its admissibility.  If FDA does not wish to examine the entry, the product is allowed to proceed into United States commerce.  Generally, if FDA decides to examine an entry, an agency representative will collect a sample from the shipment for laboratory evaluation.  If the analysis indicates that the product complies with the Act and related regulations, the shipment may be released into United States commerce.  If there is a violation, the product will be detained.  If not brought into compliance, the product will be refused admission.

Cont.. : 

Cont.. Refusal of Admission Section 801 of the Act directs FDA to refuse admission to any article that appears to be in violation of the Act.  If admission of the product is refused, the importer must either re-export or destroy the product under Customs or other approved supervision.  If the product is not destroyed or re-exported, Customs issues a notice for redelivery to the importer of record.  Application to Recondition If admission is refused, the importer may submit an application to recondition the product to bring it into compliance with the Act Detention Without Physical Examination In some instances, a product may be detained without physical examination as soon as it is offered for entry into the United States.  This process is based on history and/or other information indicating that the product may be violative.

Cont… : 

Cont… Import Alerts The purpose of an Import Alert is to identify and disseminate import information (such as problems and violative trends) to FDA personnel, thus providing more uniform and effective import coverage. Computerization To assure the expeditious handling of imported products, FDA has automated its import operations.  By combining FDA's Operational and Administrative System for Import Support (OASIS) and Customs' Automated Commercial System (ACS), an FDA reviewer can more efficiently evaluate and process each import entry.

Cont…. : 

Cont…. Information's and records :- The regulations shall require an importer to submit following information and documentation:- Name and quantity of active ingredient of drug. A description of dosage form The date on which drug is shipped The quantity of drug shipped The point of origin and destination of drug The price paid by importer Documentation from foreign seller specifying the original source of drug (ii) the qty of each lot of prescription drug originally received by seller from that source. Name.address,telephone no. and professional licence no. of importer.

MEDICAL DEVICE REGULATIONS OF U.S : 

MEDICAL DEVICE REGULATIONS OF U.S Export Requirements Flowchart The Medical Device Export Decision Tree flow diagram below depicts a firm's options to export as revised by the FDA Export Reform and Enhancement Act of 1996 (FDERA). This quick reference chart shows when to export under sections 801(1), 801(e)(2), and 802 of the FD&C Act.

Cont.. : 

Cont.. Requirements 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 provisions under section 802 of the FD&C Act only applies to unapproved devices. For a device to be legally in commercial distribution in the U.S., the following requirements must be met: The manufacturing facility must be registered with FDA; The device must be listed with FDA; The device must have a cleared Premarket Notification 510(k) or Premarket Approval (PMA). The device must meet the labeling requirements of 21 CFR Part 801and 21 CFR 809, if applicable; The device must be manufactured in accordance with the Quality Systems (QS) Regulation of 21 CFR Part 820 (also known as Good Manufacturing Practices or GMP), unless exempted by regulation.

IMPORT MEDICAL DEVICE : 

IMPORT MEDICAL DEVICE In order to import medical devices into the U.S., the product must meet FDA regulatory requirements. FDA does not recognize regulatory approvals from other countries Foreign manufacturers must meet applicable United States (U..S.) medical device regulations in order to import devices into the U.S. even if the product is authorized for marketing in another country. These requirements include registration of establishment, listing of devices, manufacturing in accordance with the quality system regulation, medical device reporting of adverse events, and Premarket Notification 510(k) or Premarket Approval Entry information should identify the product and include appropriate information to demonstrate that the product is in compliance with FDA regulations. Product information should include device name and product code.

Cont. : 

Cont.

EUROPE EXPORT REGULATIONS : 

EUROPE EXPORT REGULATIONS The MHRA, on behalf of the Department of Health, issues export certificates on request to assist exporters of medicinal products to satisfy the import requirements of other countries. The certificates issued by MHRA Where necessary, the format of certificates complies with that specified by international authorities, for example, the World Health Organization (WHO) The MHRA issues four different types of export certificates, two of which comply with the format established by the WHO. Each type of certificate is country specific, naming one individual country - the EU is not acceptable as a one-country unit. The fee charged is the same for each type of certificate but varies dependent on the service level (24-hour or five-day turnaround) requested and the number of original copies required.

Cont. : 

Cont. Certificate of a pharmaceutical product (CPP). 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 UK. It provides details about the product ,the active ingredients and excipients, the manufacturing and packaging sites and whether or not the product is placed on the market in the UK. Certificate of licensing status (CLS). 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 products. It provides less information than the CPP and can include a maximum of ten products per certificate.

Slide 47: 

Certificate of manufacturing status (CMS) It does not provide any product specific information, but it confirms whether named sites meet Good Manufacturing Practice (GMP) requirements on a specified manufacturing license number. All or any of the sites named on the manufacturing licence may be listed on the certificate. Certificate for the importation of a pharmaceutical constituent (CPC) is available for a named constituent of a medicinal product.

Cont.. : 

Cont.. The MHRA will only issue certificates for unlicensed medicinal products that are manufactured in the UK on a site holding a manufacturer's licence appropriate to the dosage form of the product for which the certificate applies. If an application is made for a certificate for a medicinal product that is not manufactured in the UK it will only be issued if the product has a UK (not EMEA) product licence. It is not possible to issue a certificate for unlicensed products manufactured outside the UK. Information for completion of export certificate application formsThe certificate of a pharmaceutical product (CPP) 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 from the applicant's, name of importing country, standard or urgent service, language and number of copies required

Cont… : 

Cont… The MA/PL number must be quoted along with the name and dosage form of the product A certificate can only state one strength. A product may be registered under several names but only one name can be quoted on the certificate. However a different name may be quoted in the importing country. The list of actives and excipients and their full quantitative formulation must be as detailed against the MA/PL number. The certificate of manufacturing status requires the manufacturing license holder number - this must be a UK license holder, an overseas license number is not acceptable. If more than one site is included on the license the applicant can select which or all of the sites to include on the certificate

Slide 50: 

The certificate of licensing status is limited to ten products per certificate and is country specific. Details of the product name, dosage form, active ingredients and amounts should all be quoted in accordance with their product license (if applicable) and these details will be checked against the MHRA database. Any differences will be queried and will need to be verified. The certificate for the importation of a pharmaceutical constituent is country and ingredient specific.

IMPORT regulations OF EU : 

IMPORT regulations OF EU The UK Parallel Import Licensing Scheme allows medicinal products authorized in other EU Member States to be marketed in the UK, provided the imported products have no therapeutic difference from the equivalent UK products Parallel import license application categories :- From 1 April 2009 Parallel Import License applications are in one of three categories. The fees for the categories are different so it is important that the correct category is selected.

Cont. : 

Cont. The categories are: Parallel import (simple)This category will apply when the UK product and the product to be imported from a Member State are manufactured by companies in the same group of companies or are made under license from the same licensor. This is the traditional ‘common origin’ criterion. Parallel import (standard) This category will apply when the UK and imported products do not share a common origin (as defined above) and the application is not ‘Complex’ (see below). Parallel import (complex) This category will apply when the UK and imported products do not share a common origin (as defined above) and:

Cont. : 

Cont. (a) the imported product contains a new excipient (b) the imported product contains an active ingredient made by a different route from that used in the UK product (c) the imported product is a controlled release preparation (d) the imported product is a sterile product which is sterilized in a different way from the UK product (e) the imported product is a sterile product in which the container is made from a different material to the container of the UK product

Cont.. : 

Cont.. (f) the imported product is an influenza vaccine (g) the product is a metered dose inhaler (h) the product is a powder for inhalation (i) bioequivalence of the UK and imported product cannot be demonstrated through bioavailability studies (j) the sole or primary evidence for the safety and efficacy of the imported product consists of published scientific literature (k) the manufacturer of the active ingredient contained in the imported product is different from the manufacturer of the active ingredient contained in the UK product

JAPAN IMPORT REGULATIONS : 

JAPAN IMPORT REGULATIONS 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 .

Cont. : 

Cont. 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 manufacturing no. Content quantity e.g. volume, weight Storage condition, effective period and other specified matter, information Name of API Expiration date of medicine Words ‘attention’: habitual1 for medicine designated by MHRW as habitual drugs.

Japan import regulations : 

Japan import regulations

Global Medical Device Market Growth Potential : 

Global Medical Device Market Growth Potential The global medical device market is projected to exceed $250 Billion by 2012 U.S., UK, Japan, Germany, France, and Italy 15% of population, 75% of medical device use China, India, Indonesia, Brazil and Pakistan have about half of the world’s population but consume only about 5% of medical devices globally

Global Medical Device Market— U.S. Position : 

Global Medical Device Market— U.S. Position U.S. medical technology companies lead the world in medical device production The U.S. is the world’s largest market for medical technologies ($85 Billion) U.S. share of world medical device market has held at roughly 45-47% in recent years

JAPAN : 

JAPAN 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 Devices in Japan Pharmaceuticals and Medical Devices Agency (PMDA), or Kiko Reviews product applications Isn’t a government agency Needs more device specialists as reviewers Ministry of Health, Labor and Welfare (MHLW) Approves product applications Is a government agency

Cont.. : 

Cont.. Average Medical Device Approval Times European Union: 6 Months. United States: 3 to 10 Months. Japan: 12 to 36 Months

Cont.. : 

Cont.. 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

references : 

references http://trade.gov/index.asp http://trade.gov/mac/index.asp http://www.mac.doc.gov/japan http://trade.gov/cs/index.asp http://www.buyusa.gov/japan/en/ccg.html 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 Vijay malik,drug and cosmetic act and rules 1940 Mhra.gov.in Consumer protection act of japan . Sidney h.willig,GMP for pharmaceuticals,5th edition,page no.425-437. www.emea.europe.in Vidya sagar,pharmaceutical industrial management,page no. 325-335

Slide 66: 

THANK YOU