  
  
G/TBT/N/JPN/683  
6 January 2021  
(21-0230) 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 (MHLW)  
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):  (HS: 30 , 
90 ) 
5. Title, number of pages and language(s) of the notified document:  Partial revision 
of Regulation for Enforcement of the Act on Securing Quality, Efficacy and Safety of 
Products Including Pharmaceuticals and Medical Devices. (2 page(s), i n English)  
6. Description of content:  The amendment to the Act on Securing Quality, Efficacy and 
Safety of Products Including Pharmaceuticals and Medical Devices was established in 
December 2019. The amendment to the Act introduced the system in Japan according to 
which Marketing Authorizatio n Holders (MAHs) basically use electronic methods such as 
barcodes when providing information on pharmaceuticals and medical devices. The 
Ordinance for Enforcement of the Act will be amended to specify the details of the system.  
7. Objective and rationale , including the nature of urgent problems where 
applicable:  To ensure the efficacy and safety of pharmaceutical products.; Other  
8. Relevant documents:   
The Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals 
and Medical Devices.  
http://www.japaneselawtranslation.go.jp/law/detail/?re=01&co=01&ia=03&ja=04&x=0
&y=0&kn[]=%E3%81%84&ky=%E5%8C%BB%E8%96%AC%E5%93%81&page=4  
This amendment was published i n "KAMPO" (Official Gazette).  
9. Proposed date of adoption:  February 2021 (planned)  
Proposed date of entry into force:  August 2021 （planned ） 
10. Final date for comments:  60 days from notification  G/TBT/N/JPN/683  
 
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  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_0258_00_e.pdf  
 