  
  
G/TBT/N/JPN/729  
7 March 2022  
(22-2057) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  JAPAN   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:  Ministry of Health, Labour and Welfare  
Name and address (including telephone and fax numbers , email and website 
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 [   ], 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):  
PHARMACEUTICAL PRODUCTS (HS: 30  ) 
5. Title, number of pages and language(s) of the notified document:  (1) Partial 
amendment to the Minimum Requirements for Biological Products (2) Partial amendment 
to the Public Notice on National Release Testing (1 page(s), in English)  
6. Description of content:  (1) The Minimum Requirements for Biological Products will be 
partially amended to add the standard for a vaccine product to be newly approved. (2) 
The fee, criterion and test sample quantity for National Release Testing will be partially 
amended to provide for the above -mentioned vaccine product.  
7. Objective an d rationale, including the nature of urgent problems where 
applicable:  (1) To establish the standard for manufacturing process, properties, 
quality, storage and others of pharmaceuticals to which special attention must be paid 
for the attainment of public health and sanitation (Biological products). (2) To stipulate 
Biological products as subject to National Release Testing, as well as fee, criterion and 
quantity for the testing.  
Other  
8. Relevant documents:   
Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and 
Medical Devices.  
http://www.japaneselawtranslation.go.jp/law/detail/?id=3213&vm=04&re=2&new=1  
This amendment will be published in " KAMPO " (Official Gazette) when adopted.  
9. Proposed date of adoption:  The same day as the approval of the above -mentioned 
vaccine product.  
Proposed date of entry into force:  The same day as the approval of the above -
mentioned vaccine product.  G/TBT/N/JPN/729  
 
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  10. Final date for comments:  30 days from notification  
11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Japan Enquiry Point  
International Trade Division,  
Economic Affairs Bureau,  
Ministry of Foreign Affairs  
Fax: (+81 3) 5501 8343  
E-mail: enquiry@mofa.go.jp  
https://members.wto.org/crnattachments/2022/TBT/JPN/22_1898_00_e.pdf  
 