EXPORT:-

IMPORT:-
 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
 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 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
 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.Mate’s receipt
13. Bill of loading
14. Marine insurance
15. Forwarding agent advice
16. Preparation of export invoice
17. Payment
18. Advice to importer
1. Obtaining import licence
2. Foreign exchange
3. Placing the indent
4. Dispatch of goods by export agent
5. Obtaining shipment documents
6. Appointment of clearing agent
7. Endorsement of delivery
8. Payment of import duty dock dues
9. Taking delivery of goods
10. Keeping goods in warehouse
11. Dispatch of goods by clearing agent
12. Receipt of documents
13. Taking the delivery
 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.
 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.

 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.
 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.
 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.

 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.
 IMPORT OF MEDICAL DEVICES

Forthe 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.        
 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.        
 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/-.
 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
 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.
 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.
 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
 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.
 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
 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.
 Attachments:

   Model Certificate to Foreign Government

 
  Model Certificate of Exportability - Section 802
 
  Model Certificate of Exportability - Section 801(e)
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.
 
 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.
 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
_____________________________
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
 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.
 
 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.
 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.
 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. 
 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.
 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.
 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.
 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.
Number Medical Specialty Regulation
73 Anesthesiology Part 868
74 Cardiovascular Part 870
75 Chemistry Part 862
76 Dental Part 872
77 Ear, Nose, and Throat Part 874
78 Gastroenterology and Urology Part 876
79 General and Plastic Surgery Part 878
80 General Hospital Part 880
81 Hematology Part 864
82 Immunology Part 866
83 Microbiololgy Part 866
84 Neurology Part 882
85 Obstetrics and Gynocology Part 884
86 Ophthalmics Part 886
87 Orthopedics Part 888
88 Pathology Part 864
89 Physical Medicine Part 890
90 Radiology Part 892
91 Toxicology Part 862
 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.
 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.
 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.
 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 forms

The 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
 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
 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.
 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.
 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:
 (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
 (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
 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

.
 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.
 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
 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 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.
 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
Average Medical Device Approval Times

 European Union: 6 Months.

 United States: 3 to 10 Months.

 Japan: 12 to 36 Months
 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
 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