G/TBT/N/JPN/743  
12 July 2022  
(22-5318) 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 code(s): 30)  
5. Title, number of pages and language(s) of the notified document:  Partial 
amendment to the Minimum  Requirements for Biological Products (1 page, available in 
English)  
Partial amendment to The Public Notice on National Release Testing.  
6. Description of content:  The Minimum Requirements for Biological Products will be 
amended as follows ；To add the stan dard, criterion, fee and quantity for a vaccine product 
to be newly approved; "Meningococcal tetravalent polysaccharide tetanus toxoid 
conjugate vaccine", "Pneumococcal 15 -valent conjugate vaccine". Partially amended to 
"Meningococcal tetravalent polysacch aride diphtheria toxoid conjugate vaccine", 
"Pneumococcal Vaccine Polyvalent", "Pneumococcal 13 -valent conjugate vaccine", 
"Smallpox Vaccine Prepared in Cell Culture", "Freeze -dried Smallpox Vaccine Prepared in 
Cell Culture". To delete "Pneumococcal 10 -valent conjugate vaccine", "Smallpox Vaccine", 
"Freeze -dried Smallpox Vaccine".  
The Public Notice on National Release Testing will be amended as follows ； To add the 
criterion, fee and quantity for a vaccine product to be newly approved; "Meningococcal 
tetrava lent polysaccharide tetanus toxoid conjugate vaccine", "Pneumococcal 15 -valent 
conjugate vaccine". Partially amended to "Meningococcal tetravalent polysaccharide 
diphtheria toxoid conjugate vaccine", "Pneumococcal Vaccine Polyvalent", "Pneumococcal 
13-valent conjugate vaccine", "Smallpox Vaccine Prepared in Cell Culture", "Freeze -dried 
Smallpox Vaccine Prepared in Cell Culture". To delete "Pneumococcal 10 -valent conjugate 
vaccine", "Smallpox Vaccine", "Freeze -dried Smallpox Vaccine".  G/TBT/N/JPN/743  
 
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  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 special 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 f or the testing.  
8. Relevant documents:   
Act on Securing Quality, Efficacy and Safety of Products Including 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:  September 2022  
Proposed date of entry into force:  September 2022  
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/2022/TBT/JPN/22_4626_00_e.pdf