Presidential Regulation no. 6 of 2023 concerning Halal Certification of Medicines, Biological Products and Medical Devices.

This Presidential Regulation, implementing provisions of article 142 paragraph 41) of the Government Regulation no. 39 of 2021 on the organisation of Halal product assurance, concerns the halal certification of drugs, biological products, and medical devices. The Regulation defines: biological products; halal products, and specifies the criteria and guidelines for halal production methods, including the commitment and responsibility of the business actors, the materials, the processes, the products, and the monitoring and evaluation. The Regulation specifies the biological products as those products containing enzymes, antibodies monoclonals, hormones, stem cells, gene therapy, vaccines, blood products, recombinant DNA products, and originating from animals, plants, microbes, materials that produced through chemical processes, biological processes, or genetic engineering processes. The Regulation concerns: production facilities for processing, storage and packaging of halal products; safety requirements.