G/TBT/N/JPN/751  
31 October 2022  
(22-8144) 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 Na tional Release Testing.  
6. Description of content:  The Minimum Requirements for Biological Products will be 
amended as follows; The test for abnormal toxicity ("test for freedom from abnormal 
toxicity") will be deleted from monographs for "Influenza HA Va ccine", "Diphtheria 
Toxoid", "Adsorbed Diphtheria Toxoid", "Adsorbed Diphtheria -tetanus Combined Toxoid", 
"Tetanus Toxoid", "Adsorbed Tetanus Toxoid", "Adsorbed Purified Pertussis Vaccine", 
"Adsorbed Diphtheria -purified Pertussis -tetanus Combined Vaccine",  "Adsorbed 
Diphtheria -purified Pertussis -tetanus -inactivated polio (Sabin strain) Combined Vaccine", 
and "Adsorbed Diphtheria -purified Pertussis -tetanus -inactivated polio (Salk Vaccine) 
Combined Vaccine".  
The Public Notice on National Release Testing will  be amended as follows; Partially 
amended to"Influenza HA Vaccine", "Diphtheria Toxoid", "Adsorbed Diphtheria Toxoid", 
"Adsorbed Diphtheria Toxoid for Adult Use", "Adsorbed Diphtheria -tetanus Combined 
Toxoid", "Tetanus Toxoid", "Adsorbed Tetanus Toxoid", " Adsorbed Purified Pertussis 
Vaccine", "Adsorbed Diphtheria -purified Pertussis -tetanus Combined Vaccine", "Adsorbed 
Diphtheria -purified Pertussis -tetanus -inactivated polio (Sabin strain) Combined Vaccine", 
"Adsorbed Diphtheria -purified Pertussis -tetanus -inactivated polio (Salk Vaccine) 
Combined Vaccine", with the amendment of The Minimum Requirements for Biological 
Products.  
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 G/TBT/N/JPN/751  
 
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  health and sanitation as subject to National Release Testing, as well as fee, criterion and 
quantity for the testing.  
8. Relevant documents:   
Act on Securing Quality, Eff icacy 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" (O fficial Gazette) when adopted.  
9. Proposed date of adoption:  December 2022  
Proposed date of entry into force:  December 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_7337_00_e.pdf