  
  
G/TBT/N/IDN/157  
11 July 2023  
(23-4689) 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:   
Directorate General of Pharmaceutical and Medical Devices, Ministry of Health  
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:   
Jl. H.R. Rasuna Said No. 4 -9 Kuningan, Kec. Setiabudi, Kota Jakarta Selatan, DKI Jakarta 
12950  
Phone : +621 5213604  
Email : setditjen.farmalkes@kemkes.go.i d 
Website : https://farmalkes.kemkes.go.id/  
Halal Product Assurance Organizing Agency (BPJPH), Ministry of Religious Affairs  
Jl. Raya Pondok Gede No. 13 Pinang Ranti, Kec. Makasar,  
Kota Jakarta Timur, DKI Jakarta 13560  
Phone : +621 34833020  
Email : humasbpjph@kemenag.go.id  
Website : www.halal.go.id  
Directorate of Implementation System for Standards and Conformity Assessment National 
Standard ization 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.indon esia@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 [X], 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):  Medicines, 
biological products and medical devices  
5. Title, number of pages and language(s) of the notified document:  Presidential 
Decree Number 6 of 2023 regarding Halal Certification of Medicines, Biological Products, 
and Medical Devices; (14 page(s), in Indonesian)  G/TBT/N/IDN/157  
 
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  6. Description of content:  Presidential Decree Number 6 of 2023 is  a mandate of 
Government Regulation No. 39 of 2021 regarding Implementation of Halal Product 
Assurance, article 142 paragraph (4).  
Government Regulation No. 39 of 2021 regulates the obligations for products that 
entering, circulating, and traded in the ter ritory of Indonesia is required to have a halal 
certificate issued by Halal Product Assurance Organizing Agency (BPJPH), Ministry of 
Religious Affairs. The products regulated by the halal obligations including medicines, 
biological products and medical dev ices that must be halal certified.  
Government Regulation No. 39 of 2021 regulates the stages of the obligation of halal 
certification for medicines and medical devices risk class A, B, and C.  
Presidential Decree No. 6 of 2023 regulates:  
a. provisions for p roducts in the form of medicines, biological products, and medical 
devices originating from non -halal materials and/or the method of production are not yet 
halal, as follows:  
1) Medicines, biological products, and medical devices originating from non - halal 
materials or materials are not yet sourced from halal sources can be circulated and can 
be circulated and traded in Indonesia by including Non - Halal Information on the products.  
2) Medicines, biological products, and medical devices originating from halal materials 
and the method of production are not yet halal shall include a Non -Halal Information 
stated on the product labelling in the form of writing "made of halal materials and  in the 
process to comply with the halal method of production ". 
b. The obligation of halal certification for medical devices is only for medical devices 
originating from animals and/or containing animal derived substances.  
c. Guidelines for halal productio n methods in the series of making halal medicines, 
biological products, and medical devices.  
d. The stages of the obligation of halal certification for biological products and risk class 
D medical devices which requires longer time in the staging of halal obligations.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:   
To ensure the fulfilment of the needs for halal medicines, biological products, and medical 
devices for Muslim consumers in Indonesia.  
Medicine, biological  products, and medical devices originating from non -halal materials 
and/or the method of production are not yet halal can still be circulated and used in health 
services. A longer staging out of the of halal certification for biological products and 
medica l devices risk class D is needed to develop halal raw materials and/or halal 
production practices.  
Medicines, biological products, and medical devices originating from non -halal materials 
or materials not yet sourced from halal materials can be circulated by including 
information of the origin of the materials until halal materials and/or the halal production 
methods are found.  
Consumer information, labelling; Prevention of deceptive practices and consumer 
protection  
8. Relevant documents:   
Law No. 33 of 2014 on Halal Product Assurance Act  
Government Regulation No. 39 of 2021 on Implementation of Halal Product Assurance  
Decree of the minister of religion No. 748 of 2021 regarding Types of Products Mandatory 
to be Halal Certified  G/TBT/N/IDN/157  
 
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  9. Proposed date of adopti on: 19 January 2023  
Proposed date of entry into force:  19 January 2023  
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, 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 Not ification 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  
https://members.wto.org/crnattachments/2023/TBT/IDN/23_10938_00_x.pdf  
 