Indonesia Halal Certification

The Indonesian Government issued Presidential Regulation Number 6 Year 2023 regarding Halal Certification for Medicines, Biological Products, and Medical Devices.  The regulation stipulates those medicines, biological products, and medical device that entered, circulated, and are marketed in the territory of Indonesia must have a halal certificate.  The regulation requires medicines, biological products, and medical devices sold in Indonesia to be certified free of pork derivatives or anything else forbidden by Islamic law.  Compliance applies to all business processes, including materials, manufacturing, storage, and packaging.

The referred medicines include medicine ingredients, over-the-counter medicine, limited over-the-counter medicine, prescription medicine, traditional medicine, health supplements, and quasi-medicine. Narcotic and psychotropic medicines are exempt from the obligation to obtain a halal certificate.  

Biological products that must obtain a halal certification include enzymes, monoclonal antibodies, hormones, stem cells, gene therapy, vaccines, blood products, recombinant Deoxyribonucleic Acid (DNA) products, and immunosera.

Meanwhile, medical devices that must obtain a halal certificate include in-vitro reagents and calibrators, software, and ingredients or materials used individually or in combination to prevent fertilization, disinfection of medical devices, and in-vitro testing of specimens from the human body, and may contain drugs that do not achieve the leading work on the human body through pharmacological, immunological, or metabolic processes to be able to help the desired function or work. Medical devices with a halal certificate are only for those originating from animals and/or containing animal elements. 

This regulation was promulgated and entered into force on January 19, 2023, nearly six months before being notified to the WTO TBT Committee.  By finalizing the regulation before notifying the measure or taking stakeholder comments into account, Indonesia missed an opportunity to confer with outside stakeholders to prevent the creation of unnecessary obstacles to international trade.

Indonesia requires halal certification for various services in this regulation, including processing, packaging, and storage.  Still, it has yet to adequately engage stakeholders or provide clarity on the necessity or actionability of that requirement.

The United States remains committed to working with Indonesia to address the concerns mentioned above and those raised by other Members of this Committee and to ensure that Indonesia’s halal measures do not create unnecessary obstacles to international trade.

For more information on the policy, please contact Pepsi Maryarini (Pepsi.Maryarini@trade.gov)