G/TBT/N/IDN/153  
4 May 2023  
(23-3143) Page: 1/3 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  INDONESIA  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
Indonesian Food and Drug Authority (FDA)  
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 for Cooperation and Public Relations  
Indonesian Food and Drug Authority (FDA)  
Jl. Percetakan Negara No.23  
Jakarta 10560 – Indonesia  
Telephone : +(62 -21) 42875379  
Facsimile : +(62 -21) 42875379  
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 Indonesia  
Gedung 2 Laboratorium SNSU BSN, Komplek Puspiptek, Muncul, Tangerang Selatan, 
Banten 15314  
Email: tbt.indonesia@bsn.go.id  and tbt.indonesia@gmail.com  
Website: http://www.bsn.go.id  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Drug 
Materials, Traditional Drug Materials, Cosmetic Materials, Health Supplement Material s, 
Food Materials.  
5. Title, number of pages and language(s) of the notified document:  Indonesian FDA 
Regulation No. 26 of 2022 on Supervision of the Importation of Drug and Food Materials 
into Indonesian Territory; (23 page(s), in Indonesian)  
6. Descrip tion of content:  This regulation is the amendments to Indonesian FDA 
Regulation No. 29 of 2017 on Supervision of the Importation of Drug and Food Materials 
into Indonesian Territory. New provisions changed on this regulation include:  
a. Additional regulation on the entry of certain drug materials (Propylene Glycol, 
Polyethylene Glycol and other materials with limited levels of Ethylene Glycol and 
Diethylene Glycol for pharmaceutical grade) through Post Border Import 
Notification Letter (S urat Keterangan Impor) mechanism.  G/TBT/N/IDN/153  
 
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  b. The amendment of the operational definition of Border Import Notification Letter 
and Post Border Import Notification Letter.  
c. The adjustment of Special Access Scheme mechanism under Indonesia FDA 
supervision such as for Biological Products; Research Drugs (excluding Biological 
Products, narcotics, psychotropics and pharmaceutical precursors); and Drug 
Materials.  
d. The amendment of the provision of importation realization report submitted by 
business actors.  
e. The addition of several drug materials to the list of drug materials attachments 
which is supervised by Indonesia FDA.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  As guidelines for The Importation of Drug and Food Materials into Indonesian 
Territory; Protection of human health or safety  
8. Relevant documents:   
1. Law Number 10 of 1995 regarding Customs and Excise Affairs (State Gazette of 
the Republic of Indonesia year 1995 Number 75, additional State Gazette of the 
Republic of Indonesia Number 3612) as amended by Law Number 17 of 2006 
regarding the amendments to Law Number 10 of 1995 regarding Customs and 
Excise Affairs (State Gazette of the Republic of Indonesia year 2006 Number 93, 
additional State Gazette of the Republic of I ndonesia Number 4661);  
2. Presidential Regulation Number 80 of 2017 concerning the Drug and Food Control 
Agency (State Gazette of the Republic of Indonesia year 2017 Number180);  
3. Indonesian FDA Regulation Number 21 of 2020 on the Organization and Work 
Procedur e of Indonesian Food and Drug Authority (State Gazette of the Republic 
of Indonesia year 2020 Number 1002) as amended by Indonesian FDA Regulation 
Number 13 of 2022 on the amendments to Indonesian FDA Regulation Number 
21 of 2020 on the Organization and Wo rk Procedure of Indonesian Food and Drug 
Authority (State Gazette of the Republic of Indonesia Year 2022 Number 629);  
4. Indonesian FDA Regulation Number 22 of 2020 on the Organization and Working 
procedure of Technical Implementation Unit within the Indonesi an Food and Drug 
Authority (State Gazette of the Republic of Indonesia Year 2020 Number 1003) 
as amended several times, the lates by Indonesian FDA Regulation Number 24 of 
2022 on the second amendments to Indonesian FDA Regulation Number 22 Year 
2020 the O rganization and Working procedure of Technical Implementation Unit 
within the Indonesian Food and Drug Authority (State Gazette of the Republic of 
Indonesia Year 2022 Number 1111);  
5. Indonesian FDA Regulation Number 23 of 2020 on the Organization and Working  
procedure of Technical Implementation Unit within the Indonesian FDA National 
Quality Laboratory of Drug and Food (State Gazette of the Republic of Indonesia 
Year 2021 Number 1004);  
6. Indonesian FDA Regulation Number 10 of 2021 on Standards for Business 
Activities and Products on the Implementation of Risk -Based Business Licensing 
for the Drug and Food Sector (State Gazette of the Republic of Indonesia Year 
2021 Number 292).  
9. Proposed date of adoption:  14 November 2022  
Proposed date of entry into force:  14 December 2022  
10. Final date for comments:  60 days after notification.  G/TBT/N/IDN/153  
 
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  11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
https://members.wto.org/crnattachments/2023/TBT/IDN/23_09447_00_x.pdf