G/TBT/N/JPN/761  
23 January 2023  
(23-0524) 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 ab ove:  
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.; ( 2 page(s), in 
English)  
6. Description of content:  The Minimum Requirements for Biological Products will be 
amended as follows ；To add the standard for a vaccine product to be newly approved; 
"Nasally Live Attenuated Influenza Vaccine", "Adsorbed Diphtheria -purified Pertussis -
tetanus -inactivated polio Haemophilus TYPE b Combined Vaccine". Partially amended to 
"Diphtheria Toxoid", "Adsorbed Diphtheria Toxioid", "Adsorbed Diphtheria Toxioid for 
Adult Use", "Adsorbed Diphtheria -tetanus Combined Toxoid", "Tetanu s 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", "Freeze -dried Haemophilus 
TYPE b Vaccine (Tetanus Toxoid Conjugate)", "Inactivated Polio Vaccine (Salk Vaccine)". 
To delete "Adsorbed Diphtheria -purified Pertussis -tetanus -inactivated polio (Salk Vaccine) 
Combined Vaccine".  
The test for pH and test for abnormal toxici ty ("test for freedom from abnormal toxicity") 
will be deleted from monographs for "Freeze -dried Inactivated Tissue Culture Hepatitis A 
Vaccine", "Freeze -dried Gas Gangrene Antitoxin, Equine", "Freeze -dried Inactivated 
Tissue Culture Rabies Vaccine", "Free ze-dried Diphtheria Antitoxin, Equine", "Freeze -dried 
Habu Antivenom, Equine", "Freeze -dried Botulism Antitoxin, Equine", "Freeze -dried 
Mamushi Antivenom, Equine".  
The Public Notice on National Release Testing will be amended as follows ；To add the 
standard  for a vaccine product to be newly approved; "Nasally Live Attenuated Influenza 
Vaccine", "Adsorbed Diphtheria -purified Pertussis -tetanus -inactivated polio Haemophilus 
TYPE b Combined Vaccine". Partially amended to "Diphtheria Toxoid", "Adsorbed G/TBT/N/JPN/761  
 
- 2 - 
 
  Diphtheria  Toxioid", "Adsorbed Diphtheria Toxioid for Adult Use", "Adsorbed Diphtheria -
tetanus Combined Toxoid", "Zoster Vaccine Recombinant, Adjuvanted", "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", "Freeze -dried Haemophilus 
TYPE b Vaccine (Tetanus Toxoid Conjugate)", "Inactivated Polio Vaccine (Salk Vaccine)" 
"Freeze-dried Inactivated Tissue Culture Hepatitis A Vaccine", "Freeze -dried Gas 
Gangrene Antitoxin, Equine", "Freeze -dried Inactivated Tissue Culture Rabies Vaccine", 
"Freeze -dried Diphtheria Antitoxin, Equine", "Freeze -dried Habu Antivenom, Equine", 
"Freeze -dried Botulism Antitoxin, Equine", "Freeze -dried Mamushi Antivenom, Equine", 
"Human Anti -tetanus Immunoglobulin". Accordingly, the fee, criterion and quantity for 
National Release Testing of the above -mentioned vaccine will be partially amended. To 
delete  "Adsorbed Diphtheria -purified Pertussis -tetanus -inactivated polio (Salk Vaccine) 
Combined Vaccine".  
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 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 " (Official Gazette) when adopted.  
9. Proposed date of adoption:  March 2023  
Proposed date of entry into force:  March 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_0592_00_e.pdf