WORLD TRADE  
ORGANIZATION   
G/TBT/N/IDN/61 
16 July 2012  
 (12-3827) 
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:  kerjasamaln_bpom@yahoo.co.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):  Pharmaceutical Products 
5. Title, number of pages and langua ge(s) of the notified document:  Regulation of the Head 
of NADFC RI  No. HK.03.1.3.12.11.10692 of 2011 concerning the Importation Control of 
Pharmaceutical Products, (9 page s, in Bahasa Indonesia)    
6. Description of content:  This Regulation repla ces Regulation of the Head of NADFC RI 
No. HK.00.05.1.3459 of 2005 concerning the Importation Control of Pharmaceutical 
Products.  
Importation of Pharmaceutical Products can only  be done by the Pharmaceutical Industries 
which hold marketing authorization from the He ad of NADFC hold marketing authorization 
from the Head of NADFC. In the implementation,  the Pharmaceutical Industry which has  G/TBT/N/IDN/61 
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  marketing authorization may appoint anothe r Pharmaceutical Industry or importers 
Pharmaceutical Wholesalers as the executor of pharmaceutical product importation.  
Beside comply with the applicable provi sions of importation; the importation of 
pharmaceutical products also must be approved by  the Head of NADFC RI in the form of the 
Certificate of Importation (SKI) which is  only valid for every single importation. 
SKI applied electronically through the NADF C’s website (www.pom. go.id) or through the 
NSW of NADFC (http://e-bpom.pom.go.id). Each application has been charged to expense in 
accordance with the Government Regulation of Republic of Indonesia No. 48 year 2010 on 
non-tax revenues which prevails in NADFC. 
SKI is given at the latest 1 (one) working da y after all requirements complete and correct. 
SKI application must be attached with the following documents: a. Marketing author ization of imported pharmace utical products/ bulk products; 
b. Certificate of Analysis (CoA) issued by manufacturer for each batch / lot (specifically
 in CoA of sera for human use should be de clared the source of active ingredients);  
c. Letter of appointment, if the import don e by the executor appointed by the marketing 
 authorization holder; d. Invoices; 
e. Proof of payment of State Re venue (non-tax revenues); and 
f. Bill of Lading (B / L) or Air Way Bill (AWB). 
Importation of vaccines for human use, shou ld also be completed with the following 
documents: 
a. batch/lot release certificat e issued by the authority agency of a releasing country for 
 every single importation;  
b. summary batch / lot protocol issued by the manufacturer. 
Importation of vaccines which has obtained the Certificate of Importation from NADFC can 
only be distributed after NADF C conducting sampling, evaluation and testing of imported 
vaccines. The result should meet the requirements  and the entire cost is the responsibility of 
the applicant.  
All documents related to impor tation of drug must be documen ted in accordance with the 
Guidelines of Good Di stribution Practices. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
To protect consumer from use of imported dr ug which do not fulfil safety, efficacy and 
quality requirements.  
8. Relevant documents:    
1. Government Regulation of Republic of  Indonesia No. 48 year 2010 on non-tax 
 revenues which prev ails in NADFC. 
2. Regulation of the Head of NADFC Number HK.03.1.23.10.11.08481 Year 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/61 
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  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/crna ttachments/2012/tbt/IDN/12_2593_00_x.pdf