G/TBT/N/IDN/93
8 January 2015 
(15-0116)  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: INDONESIA 
If applicable, name of local government involved (Article 3.2 and 7.2):    
2. Agency responsible: National Agency of Drug an d Food Control (NADFC) RI 
Name and address (including telephon e 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 : 
Bureau for Law and Public Relation 
National Agency of Drug and Food Control (NADFC) Republic of Indonesia 
Jl. Percetakan Negara No. 23 Jakarta 10560 - Indonesia Telephone: +(62-21) 4263333 
Facsimile: +(62-21) 4209221 
Email: humas_bpom@yahoo.com  / ulpk@pom.go.id   
Website: http://www.pom.go.id  
Bureau for International Cooperation 
National Agency of Drug and Food Control (NADFC) Republic of Indonesia Jl. Percetakan Negara No. 23 
Jakarta 10560 - Indonesia 
Telephone: +(62-21) 42875379 Facsimile: +(62-21) 42875379 Email: kerjasamaln_bpom@yahoo.co.id   
Website: http://www.pom.go.id  
Center for Cooperation on Standardization 
National Standardization Agency of Indonesia (BSN) 
BPPT I Building, 12th Floor 
Jl. M.H. Thamrin No.8 Jakarta - Indonesia 10340 
Telephone:  +62 21 3927434 ext. 127 
Facsimile:  +62 21 3927527 E-mail: tbt.indonesia@gmail.com  / tbt.indonesia@bsn.go.id   
Website: http://bsn.go.id/  
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 applic able, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable): Drugs  
5. Title, number of pages and language(s) of the notified document: Regulation of the 
Chairman of NADFC RI No. 3 Year 2013, Amendment of Regulation of the Chairman of NADFC RI No. HK.03.1.23.10.11.08481 Year 2011 on the Drug’s Criteria and Registration 
(6 pages, in Indonesian) G/TBT/N/IDN/93 
 
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  6. Description of content: This regulation of the Chairman of NADFC RI No. 3 Year 2013 
amending Article 46 and adding Article 21A, 24A, and 46A to the Regulation of the 
Chairman of NADFC RI No. HK.03.1.23.10.11.08481 Year 2011.  
• Article 21A regulated drug registration with generic name 
• Article 24A regulated the provisions in  the packaging and labelling of drugs 
• Article 46 and 46A regulated approvable letter 
7. Objective and rationale, including the nature of urgent problems where applicable: 
1. To protect people from drugs which do not meet safety and quality requirements;  
2. As guidelines for drug registration. 
8. Relevant documents:  Regulation of the Chairman of NADFC RI 
No. HK.03.1.23.10.11.08481 Year 2011 on the Drug's Criteria and Registration 
9. Proposed date of adoption:   After the date of publication 
Proposed date of entry into force:   After the date of publication 
10. Final date for comments: 60 days after notification 
11. Texts available from: Nati onal enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
Center for Cooperation on Standardization 
National Standardization Agency of Indonesia (BSN) 
BPPT I Building, 12th Floor Jl. M.H. Thamrin No.8 Jakarta – Indonesia. 10340 
Telephone: +62 21 39274 
https://members.wto.org/crnattac hments/2015/TBT/IDN/15_0071_00_x.pdf