. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/IDN/62 
17 July 2012  
 (12-3857) 
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 [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):  Raw Materials  
5. Title, number of pages and langua ge(s) of the notified document:  Regulation of the Head 
of NADFC RI  No. HK.03.1.3.12.11.10693 of 2011 concerning the Importation Control of 
Raw Materials (7 pages, in Bahasa Indonesia).     
6. Description of content:  This Regulation repla ces Regulation of the Head of NADFC RI 
No. HK.00.05.1.3460 of 2005 concerning th e Importation Control of Raw Materials  
Importation of Raw Materials can only be done by the Pharmaceut ical Industries and 
Pharmaceutical Wholesal ers with the provisions that the importation which conducted by the 
Pharmaceutical Industrie s is allowed only for its own production needs. G/TBT/N/IDN/62 
Page 2  
 
  Beside comply with the applicable provisions of imports, the importation of raw materials 
also must be approved by the Head of NADFC RI in the form of the Certificate of 
Importation (SKI) which is only va lid for every single importation. 
SKI applied electronically th rough the NADFC's website (www.pom.go.id) or through the 
NSW of NADFC (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. Certificate of Analysis (CoA); b. invoice; 
c. Bill of Lading (B / L) or Air Way Bill (AWB); 
d. Proof of payment of State Revenue (non-tax revenues); and e. Summary batch / lot protocol issued by the manufacturers, or batch / lot release 
 certificate issued by the authority agency  of a releasing count ry (applied for active 
 ingredients of vaccines only). 
All documents related to impor tation of raw materials must be documented in accordance 
with the Guidelines of Good Distribution Practices. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
A number of raw materials us ed to produce pharmaceutical products in pharmaceutical 
industries are likely to be abused for illegal purpose. In order to prevent potential abuse, it is 
needed to carry out a control at "porte  d'entrée" across territory of Indonesia.  
8. Relevant documents:   Government Regulation of Republic of Indonesia No. 48 year 2010 
on non-tax revenues which pr evails in NADFC.   
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 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_2594_00_x.pdf