Export and Import of Medicinal Products - Japanese WTO related regulations
Table of Contents
1. WTO Notification No. G/TBT/N/JPN/78 dated April 8, 2003
2. Pharmaceutical and Medical Safety Bureau Notification No.
170 dated March 6, 2001 - Issuance of Certificates for Export
of Medicinal Products
3. Pharmaceutical and Medical Safety Bureau Notification No.
170 dated March 6, 2001 - Appendix 2: (Updated ) Forms for
the Certificates for Export of Medicinal Products (English
versions)
World Trade Organization/ Committee on Technical Barriers
to Trade Notification No. G/TBT/N/JPN/78- (03-1942) dated
April 8, 2003
WORLD TRADE
ORGANIZATION
G/TBT/N/JPN/78
8 April 2003
(03-1942)
Committee on Technical Barriers to Trade
Original: English
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6.
1.
Member to Agreement notifying: JAPAN
If applicable, name of local government involved (Articles 3.2 and 7.2): _____
2.
Agency responsible: Ministry of Health, Labour and Welfare
Name and address (including telephone and fax numbers, e-mail and web-site
addresses, if available) of agency or authority designated to handle comments
regarding the notification shall be indicated if different from above: _____
3.
Notified under Article 2.9.2 [X], 2.10.1 [___], 5.6.2 [X], 5.7.1 [____], other: ______
4.
Products covered (HS or CCCN where applicable, otherwise national tariff
heading.
ICS numbers may be provided in addition, where applicable): Drugs, quasi-drugs,
cosmetics, medical devices and blood products
5.
Title, number of pages and language(s) of the notified document: Amendment of
the Enforcement Ordinance and enactment of Notifications for Implementing the
Revised Pharmaceutical Affairs Law and the Blood Collection and Donation
Arrangement Control Law.
6.
Description of content: The background and summary of the amendment of the
Enforcement Ordinance and enactment of notifications for implementing the
Pharmaceutical Affairs Law are as follows:
(1) To amend the Enforcement Ordinance and enact notifications for
implementation of the revised Pharmaceutical Affairs Law (issued in July 2002)
in July 2003.
(2) Summary
* To designate individual products which are categorized in "biological
product" or "specified biological product" in accordance with the
assessments of potential risks of infectious disease transmission;
* To enact minimum requirements for biological materials used for production
of pharmaceuticals, medical devices and cosmetics in order to
ensure their quality and safety. (Including criteria for ruminant
material collection regarding countries of origin/source
organs/tissues in order to minimize the risk of BSE transmission);
* To require GMP conformity for manufacturing control and quality assurance
of biological products and specified biological products equivalent to
those of the "biological preparations".
* To require manufacturers of specified biological products to retain the
records of retail (including wholesale) and manufacturing for a period
not less than 30 years etc.
* To require signs identifying biological products or specified biological
products on the direct package/container and to require signs
indicating the country of origin of the human blood as well as how the
blood was donated (voluntary donated or otherwise donated) for
blood products and specified biological products including human
blood.
* To stipulate the contents of periodic infectious disease reports and the
criteria for supervisors for manufacturing biological products.
7.
Objective and rationale, including the nature of urgent problems where
applicable: To improve measures to ensure safety of biological products, in
accordance with advanced technologies which can be applied to developing new
biologicals such as cell/tissue based products.
8.
Relevant documents: The Pharmaceutical Affairs Law and the Law to Secure Stable
Supply of Safe Blood Products. The Enforcement Ordinance and Notifications will
appear in "KAMPO" (Official Government Gazette) when adopted.
9.
Proposed date of adoption:
Proposed date of entry into
force:
?
To be determined
10.
Final date for comments: 30 April 2003
11.
Texts available from: National enquiry point [X] or address, telephone and fax
numbers, e-mail and web-site addresses, if available of the other body: _____
Source: World Trade Organization.
Pharmaceutical and Medical Safety Bureau Notification No.
170 dated March 6, 2001 - Issuance of Certificates for
Export of Medicinal Products (partial revision)
Table of Contents
* PMSB Notification No. 170 dated March 6, 2001
Text and Details
* Appendices
Appendix 1
Separate Table - Distribution of work responsibilities
between the PMSB divisions - in
Japanese (omitted)
Appendix 2
(Updated) Forms for the Certificates for Export of
Medicinal Products (English versions, 12
shown here)
PMSB Notification No. 170
March 6, 2001
To: All Metropolitan and Prefectural Governors
From: Director-General
Pharmaceutical and Medical
Safety Bureau, MHLW
Issuance of Certificates for Export of Medicinal Products (partial revision)
When demanded by the importing countries, the issuance of certificates
for export of medicinal products - drugs (pharmaceuticals), quasi-drugs,
cosmetics and medical devices based on the Pharmaceutical Affairs Law (Law
No. 161 of 1961) and on the requirements set forth by the Pharmaceutical Affairs
Bureau Notification No. 418 dated April 26, 1994 (partially amended by the
Pharmaceutical Affairs Bureau Notification No. 620 dated July 1, 1994 and
PMSB Notification No. 422 dated December 19, 1997), as of April 1, 2001 the
pre-export examination carried out by the Organization for Pharmaceutical
Safety and Research shall not required only for the medicinal products of the
cosmetics category which represent a combination of known ingredients.
Since the amendment shall enter into effect from April 1, 2001, please
assure that all under your jurisdiction whom it might concern are properly
familiarised with the change.
Details - changes in the individual Certificate forms (omitted)
Appendices
Appendix 1
Separate Table - Distribution of work responsibilities between the
PMSB divisions - in Japanese (omitted)
Appendix 2
(Updated) Forms for the Certificates for Export of Medicinal Products
(English versions, 12 shown here)
Form 1 - in Japanese (omitted)
Form 2 - in English (shown here)
Form 3 - in English (shown here)
Form 4 - in English (shown here)
Form 5 - in English (shown here)
Form 6 - in English (shown here)
Form 7 - in Japanese (omitted)
Form 8 - in English (shown here)
Form 9 - in English (shown here)
Form 10 - (omitted)
Form 11 - in English (shown here)
Form 12 - in English (shown here)
Form 13 - in English (shown here)
Form 14 - in English (shown here)
Form 15 - in English (shown here)
Source: Ministry of Health, Labour and Welfare.
Translation: JKS LLC
Pharmaceutical and Medical Safety Bureau Notification No.
170 dated March 6, 2001 - Appendix 2: (Updated) Forms for
the Certificates for Export of Medicinal Products (English
versions)
Note: The forms reproduced here are the versions in English, used by the
Japanese authorities.
The Forms shown below on pages 10 to 24 are facsimile copies.
The translation, formatting, indexing and hyperlinking of the text are copyrights of the
Jouhou Koukai Services LLC
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Reproduction in whole or part without permission is forbidden.
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