TBT BSN | Notification

Notification Detail :: G/TBT/N/IDN/157

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

Presidential Decree Number 6 of 2023 regarding Halal Certification of Medicines, Biological Products, and Medical Devices

Objective

Consumer information, labelling (TBT); Prevention of deceptive practices and consumer protection (TBT)

Product Covered

Medicines, biological products and medical devices

Document Notification

Link to ePing

HSCODE

ICSCODE

11.120 - Pharmaceutics

Keywords

Specific Regions

Description

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 territory 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 devices 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 products 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 productionb. 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 production 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.

Notified Document

1:File here

Link to Notification

EN:File here

FR:File here

ES:File here

Status Active

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Notification Detail :: G/TBT/N/IDN/157

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