G/TBT/N/IDN/125/Rev.1  
17 December 2019  
(19-8756) Page: 1/3 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
Revision  
The following notification is being circulated in accordance with Article 10.6.  
 
1. Notifying Member:  INDONESIA  
If applicable, name of local government involved (Articles 3.2 and 7.2):   
2. Agency responsible:  National Agency of Drug and Food Control (NADFC) Republic of 
Indonesia  
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 diff erent from above:   
Bureau for Cooperation  
National Agency of Drug and Food Control (NADFC) Republic of Indonesia  
Jl. Percetakan Negera No. 23  
Ph: +6221 4287 5379  
Fax: +6221 4287 5379  
Email: kerjasama@pom.go.id  
website: http://www.pom.go.id  
 
Directorate of Implementation System for Standards and Conformity Assessment  
National Standardization Agency of the Republic of Indonesia (BSN)  
TBT WTO Notification and Enquiry Point of Indon esia  
BPPT Building I, 12th floor  
Jln. M. H. Thamrin No. 8, Jakarta Pusat, DKI Jakarta 10340  
Phone: +62 21 3927422 ext 127  
Fax : +62 21 3927527  
Email : tbt.indonesia@gmail.com  and tbt.indonesia@bsn.go.id  
Website: http://www.tbt.bsn.go.id   
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [X], 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):  Medicines, 
Traditional Medicines, Health Supplements, Cosmetics, and Processed Food  
5. Title, number of pages and language(s) of the notified document:  Regulation of 
National Agency of Drug and Food Control (NADFC) Republic of Indonesia on 2D Barcode 
Application in Drug and Food Control (33 page(s), in Indonesian)  
6. Description of content:   
A. 2D Barcode implementation using two metho ds, consist of:  
  1. Authentication: method to tracing and verify legality, batch number, expiration 
date, and food and drug serial number  G/TBT/N/IDN/125/Rev.1  
 
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    2. Identification: method to verify food and drug legality based on marketing 
authorization  
B. Product Implementat ion: 
  1.  Authentication: prescription drugs, biological drugs, narcotics, psychotropic, OTC, 
Limited OTC with special concern, and processed food including special dietary food.    
  2.  Identification: medicine including OTC, Limited OTC, traditional med icines, health 
supplements, cosmetic and processed food.  
C. Information in 2D Barcode:  
  1. 2D Barcodes authentication contain information including:  
      a. Marketing authorization number and or product identity number that valid 
internationally;  
      b. batch number / production code;  
      c. expired date;  
      d. serialization number.  
  2. 2D Barcode Identification contain information including:  
      a. Marketing authorization number  
      b. Expiration of marketing authorization number  
D. Information obtained from the results of the scan using BPOM Mobile application  
  1. Product Name  
  2.  Marketing Authorization Number  
  3. Expiration of marketing authorization number  
  4. Name and address of manufacture  
  5. Packaging  
E. Application time  on food and drug product implemented in stages (phasing is carried 
out according to the readiness of the facilities and infrastructure of each industry):  
  1. 2D Barcode Authentication  
    a. Pharmaceutical Industry holder of marketing authorization numbe r are required to 
apply 2D Barcode in the form of Authentication no later than 2 (two) years starting from 
issuance of electronic marketing authorization.  
    b. Pharmaceutical Industry holder of marketing authorization number are required to 
apply 2D Barc ode in the form of Authentication no later than 7 (seven) years after this 
regulation enacted.  
  2. 2D Barcode Identification  
    a. Pharmaceutical Industry, Traditional Medicine Industry, Health Supplement 
Industry, Cosmetic Industry, or Food Industry hol der of marketing authorization number 
are required to apply 2D Barcode in the form of Identification no later than 6 (six) 
months starting from issuance of electronic marketing authorization.  
    b. Holder of marketing authorization for nonprescription dru gs, prescription drugs, 
traditional medicine, health supplement, cosmetic and processed food are required to 
apply 2D Barcode in the form of Identification no later than 5 (five) years after this 
regulation enacted.  
This Regulation specifically regulates g raphical representation of digital data in a two -
dimensional format with high decoding capacity that can be read by optical devices used 
for identification, track and trace.  
The application of 2D Barcodes as regulated in this Regulation includes Medicines,  
Traditional Medicines, Health Supplements, Cosmetic and Processed Foods which are 
produced domestically and / or imported into Indonesian territory for trading.  
The implementation of digital drug and processed food control systems is carried out by 
provid ing product packaging authentication technology in the form of 2D Barcode. Product 
authentication technology is an identity to guarantee the validity of the product so that it 
is traceable. The flow of digital -based drug and food processing supervision sys tem refers 
to the 2D Barcode Technical Guidelines listed in the Annex which are an integral part of 
this Regulation.  In addition to the information, 2D Barcodes can also contain other 
information in the form of serialization numbers and other product ident ities. G/TBT/N/IDN/125/Rev.1  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:  Consumer information, labelling; Prevention of deceptive practices and 
consumer protection   
8. Relevant documents:  - 
9. Proposed date of adoption:  7 December 2018  
Proposed date of entry into force:  7 December 2018  
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [X] or address, telephone or fax 
numbers  and email and website address es, if available , of other body:   
Directorate of Implementation System for Standards and Conformity Assessment  
National Standardization Agency of the Republic of Indonesia (BSN)  
TBT WTO Notification and Enquiry Point of Indonesia  
BPPT Building I, 12th floor  
Jln. M. H. Thamrin No. 8, Jakarta Pusat, DKI Jakarta 10340  
Phone: +62 21 3927422 ext 127  
Fax : +6 2 21 3927527  
Email : tbt.indonesia@gmail.com  and tbt.indonesia@bsn.go.id  
Website: http://www.tbt.bsn.go.id  
https://members.wto.org/crnattachments/2019/TBT/IDN/19_7257_00_x.pdf