G/TBT/N/JPN/772  
9 June 2023  
(23-3948) 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 [  ], 3.2 [  ], 7.2 [  ], 
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:  Partial 
amendment to the Minimum Requirements for Biological Products.  
Partial amendment to The Public Notice on National Release Testing.; (1 page(s), in  
English)  
6. Description of content:  The Minimum Requirements for Biological Products will be 
amended as follows ；The standard name of "nucleoside modified coronavirus RNA Vaccine 
(SARS -CoV-2)" will be amended to "coronavirus (SARS -CoV-2) RNA Vaccine". 
Accordingly, the test for pH, storage and expiry date will be deleted and partially amended 
for the above -mentioned vaccine.  
The Public Notice on National Release Testing will be amended as follows ； The standard 
name of "nucleoside modified coronavirus RNA Va ccine (SARS -CoV-2)" will be amended 
to "coronavirus (SARS -CoV-2) RNA Vaccine". In addition, the criterion of "Adsorbed 
Diphtheria -purified Pertussis -tetanus -inactivated polio Haemophilus TYPE b Combined 
Vaccine" will be partially amended. Accordingly, the fee, criterion, and quantity for 
National Release Testing of the above -mentioned vaccine will be partially amended.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  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). In addition, to stipulate 
the pharmaceuticals to which speci al attention must be paid for the attainment of public 
health and sanitation as subject to National Release Testing, as well as fee, criterion and 
quantity for the testing.  G/TBT/N/JPN/772  
 
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  8. Relevant documents:   
Act on Securing Quality, Efficacy and Safety of Products I ncluding Pharmaceuticals and 
Medical Devices.  
https://www.japaneselawtranslation.go.jp/en/laws/view/3213  
This amendment will be published in " KAMPO " (Official Gazette) when adopted.  
9. Proposed date of adoption:  August 2023  
Proposed date of entry into force:  August 2023  
10. Final date for comments:  30 days from notification  
11. Texts available from:  National enquiry point [ ] 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/2023/TBT/JPN/23_10142_00_e.pdf