WORLD TRADE  
ORGANIZATION   
G/TBT/N/IDN/63 
16 July 2012  
 (12-3830) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6 
 
1. Notifying Member:  INDONESIA  
If applicable, name of local governme nt involved (Article 3.2 and 7.2):     
2. Agency responsible:  National Agency of Drug an d Food Control (NADFC) RI  
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 :   
Bureau of 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 
E-mail:  mailto:humas_bpom@yahoo.com , mailto:ulpk@pom.go.id   
Website:  http://www.pom.go.id  
Bureau of 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 E-mail:  mailto:kerjasamaln_bpom@yahoo.co.id    Website:  http://www.pom.go.id  
3. Notified under Article 2.9.2 [   ], 2.10.1 [X], 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):  Drug/Medicines  
5. Title, number of pages and langua ge(s) of the notified document:  Regulation of the Head 
of NADFC RI  Nomor HK.03.1.1.23. 12.11.10690 of 2011 on Implementation of 
Pharmacovigilance in Pharmace utical Industry (30 pages, in  Bahasa Indonesia).    
6. Description of content:  The Regulation provides explanati on about the rules, technical 
guideline of Pharmacovigilance, the list of re port categorizes and report time and report 
forms.   
The rule specified that Pharmacovigilance have  to be done by monitoring and reporting on: 
a. drug safety aspects in detection, asse ssment, comprehension, and prevention of 
 adverse effects or other pr oblems related to drug use; G/TBT/N/IDN/63 
Page 2  
 
  b. changes in the risk-benefit profile of drugs and / or; 
c. quality aspects that may have impact on drug safety. 
For unexpected events, Pharmaceutic al industries are required to re port the matter to the Head 
of NADFC as per category. The provision of  each category and time line reporting in 
Pharmacovigilance are set in the guideline and annexes.  
Pharmaceutical industry who do not  perform Pharmacovigilance as set forth in this  rule may 
be subject to admini strative sanctions: 
a. Written Notice ; 
b. Prohibition to distribute drugs or  drug substances for temporarily; 
c. Withdrawal of drugs or drug substances th at do not meet safety, efficacy or quality;  
d. Destruction of drugs or drug substances  if it proves not meet  the requirements of 
 safety, efficacy or quality; 
e. Temporary cessation of produc tion activities and / or distribution of drugs or drug 
 substances.  
7. Objective and rationale, including the nature of urgent problems where applicable:   
The aim of the regulation is to  protect consumer from drugs which do not meet the safety, 
efficacy and quality requirements.  
The regulation is published as follow up and im plementation of the Mi nister of Health 
Regulation No. 1799/Menkes/Per/III/2010 co ncerning the Pharmaceutical Industry 
8. Relevant documents:    
a. Law Number 36 of 2009 re garding Health (State G azette of the Republic of 
 Indonesia of 2009 Number 144, Supplement  State Gazette of the Republic of 
 Indonesia Number 5063). b. Regulation of the Minister of He alth No. 1010/Menkes/Per/XI/2008 on Drug 
 Registration  as amended by the Re gulation of the Mini ster of Health 
 Number 1120/Menkes/Per/XII/2008.  
c. Regulation of the Minister of H ealth No. 1799/Menkes/Per/XII/2010 on the 
 Pharmaceutical Industry. d. Regulation of the Head of the NADFC No.HK.03.1.23.10.11.08481 of 2011 on  Criteria and Procedur e of Drug Registration. 
9. Proposed date of adoption:   
Proposed date of entry into force:   }  - 
10. Final date for comments:  60 days after notification.  G/TBT/N/IDN/63 
 Page 3 
 
 
  11. Text available from:  National enquiry point [X], or address, telephone and fax 
numbers, e-mail and web-site addres ses, if available of the other body:    
Center for Cooperation on Standardization 
National Standardization Agency, Indonesia (BSN) 
Manggala Wanabakti Bld, Block IV, 4th floor Jl. Jend. Gatot Subroto, Senayan 
Jakarta 10270 – Indonesia 
Telephone:  +(62-21) 5747043 Ext 262 Facsimile:  +(62-21) 5747045 
E-mail:  tbt.indonesia@gmail.com ; tbt.indonesia@bsn.go.id  , Website:  http://www.bsn.go.id  
http://members.wto.org/crnatt achments/2012/tbt/IDN/2012/12_2595_00_x.pdf