WORLD TRADE  
ORGANIZATION   
G/TBT/N/IDN/67 
1 November 2012  
 (12-5986) 
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 , 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  
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):  Drug 
5. Title, number of pages and langu age(s) of the notified document:  Decree of the Head of 
NADFC RI No. HK.03.1.23.10.11.08481 of 2011 on  the Criteria and Procedure of Drug 
Registration (317 pages, in Bahasa Indonesia). G/TBT/N/IDN/67 
Page 2  
 
  6. Description of content:  This regulation replaces the Regu lation of the Head of NADFC 
Number HK.00.05.3.1950 year 2003 on The Criteria  and Procedures of Drug Registration in 
order to meet the Regulation of Minister of Health Numb er 1010 Year 2008 as amended by 
the Regulation of Mini ster of Health Number 1120 Year 2008 and current situation of the 
ASEAN Harmonization on  Pharmaceuticals.  
The regulation specifies the categories of drug registration and its re quirements as well the 
procedure and mechanism as mandatory.  
The name of the drug can be taken from: a. generic (it is based on Indonesia Pharmacopoeia or In ternational Non-proprietary 
Names [INN] from WHO) or; 
b. trade name (it is based on self-asse ssment and the responsibility of applicant). 
The decision of approval by H ead of the NADFC based on : 
a. Evaluation result of registration docume nt and recommendation from the National 
Committee of Drug Evaluation, the Commit tee of Safety and Efficacy Evaluation, 
the Committee of Quality Evaluation, and the Committee of Product Information and 
Labelling Evaluation; 
b. Result of the pharmaceutical manuf acturing facilities in-situ inspection. 
The marketing authorization is valid for a pe riod of 5 years and can be extended through 
renewal mechanism. 
This rule also set up the detail of information and documents that should be submitted in drug 
registration as appe ar in annexes. 
The applicants are fully responsib le for the completeness of su bmitted documents, the validity 
of all information stated in drug registration document, and th e revision of data and product 
information.  
The drug importation should be done by pharm aceutical industries which hold marketing 
authorization. Those indust ries may designate other ph armaceutical industries or 
pharmaceutical wholesaler to c onduct their drug importation.  
The marketing authorization holder is obliged to monitor the safety, efficacy and quality of 
their product and report it to  the Head of NADFC.  
Any applicant who violates the provision may be subject to administrative sanctions namely: 
a. Written Warning; 
b. Cancellation of drug registration process; 
c. Suspension of  drug ma rketing authorization; 
d. Revoke of drug mark eting authorization; 
e. Other administrative sanctions in accordance with the provisions of laws. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
To protect the public from drug which do not  meet the safety, efficacy and quality 
requirements.   G/TBT/N/IDN/67 
 Page 3 
 
 
  8. Relevant documents:    
a. Law No. 8 of 1999 concerning Consumer  Protection (State Gazette Year 1999 
Number 42, Supplement Number 3821); 
b. Law Number 36 Year 2009 concerning Health (State Gazette Year 2009 
Number 144, Supplement Number 5063); 
c. Regulation of the Minister of Health No. 1799 year 2010 concerning the 
Pharmaceutical Industry; 
d. Regulation of the Minister of He alth No. 1010 year 2008 concerning Drug 
Registration as amended by the Regulation of the Mini ster of Health No. 1120 
year 2008. 
9. Proposed date of adoption:   
Proposed date of entry into force:    - 
10. Final date for comments:  60 days after notification. 
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 117 and 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/crna ttachments/2012/tbt/IDN/12_4283_00_x.pdf