  
  
G/TBT/N/JPN/713  
15 October 2021  
(21-7840) 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:  Partial 
amendment to the Public Notice on National Release Testing (1 page(s), in English)  
6. Description of content:  Amendment of the provisions for fee and quantity in the 
"Recombinant Adsorbed Hepatitis B Vaccine (Prepared from Yeast)".  
Deletion of the provision for MPL content test in "Recombinant Adsorbed Bivalent Human 
Papillomavirus -like particle   Vaccine (derived  from Trichoplusia ni cells)".  
Deletion of a part of the provision for  potency test in "Human prothrombin complex" and 
"Freeze -dried activated human blood coagulation factor VII concentrate containing factor 
X." 
Deletion of the provision for rabbit pyrogen test in "Freeze -dried ion -exchange -resin 
treated human normal immunoglobulin" and "Human anti -thrombin III."  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  To stipulate the pharmaceuticals to which special at tention 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.; 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=321 3&vm=04&re=2&new=1  
This amendment will be published in " KAMPO " (Official Gazette) when adopted.  
9. Proposed date of adoption:  In November 2021  
Proposed date of entry into force:  In November 2021  G/TBT/N/JPN/713  
 
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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/2021/TBT/JPN/21_6573_00_e.pdf  
 