Indonesia: Halal Certification For Drugs, Biological Products and Medical Devices

Ministry of State Secretariat of Indonesia promulgated the Presidential Decree 6/2023 for Halal Certification for Drugs, Biological Products and Medical Devices on 19 January 2023. The decree provides specific descriptions of the halal requirements and guarantees the public the halal certification of the drugs, biological products and medical devices that are being imported, circulated and marketed in Indonesia.

Starting 19 January 2023, Halal certification is a compulsory requirement for any marketing purposes covering drugs, biological products and medical devices in the Indonesian market with conditions that all the sources used and manufacturing processes are halal compliant. Any medical devices sourced from animals or containing animal elements are also categorized as halal compliant. The table below shows specific descriptions for each category.

The manufacturing processes stated in the decree must abide by these 5 criteria which are commitment and responsibility, ingredients, process, product and inspection and evaluation.

1. Commitment and Responsibility: in the form of a written statement from the manufacturer as evidence to commit to halal-compliant production

2. Ingredients: used in the whole production process should be halal-certified, not produced in a non-halal production facility, for any animals involved, the animals must be slaughtered in halal methods and alcohol or ethanol substances are not sourced from the liquor industry

3. Process: The manufacturer must provide a specific production process facility for halal products, documenting procedures for process, storage and packaging

4. Product: sources from halal ingredients, processes used halal methods, facilities, storage and packaging are not contaminated with non-halal products. The labeling must be clear on the identification of halal-compliant including the logo and photo used in the label

5. Inspection and Evaluation: Internal audit procedure must be done, documented and reported to the Halal Product Regulatory Body

The enforcement of Halal certification for drugs, biological products and medical devices is applied gradually based on the law and regulations. For biological products, the enforcement date is due on 17 October 2039. Meanwhile, for medical devices, the enforcement is divided by the risk class classifications, Class A, Class B, Class C and Class D. Medical devices classified under Class A, B and C will be enforced depending on law and regulations, while for Class D medical devices will be enforced on 17 October 2039.

For non-halal sourced drugs, biological products and medical devices, the manufacturers must be responsible for the product labeling, product name and evidence documents to support the documentation. Next, for drugs, biological products and medical devices that are manufactured by using halal sources and halal-compliant facilities but not yet certified halal by the regulatory authority, the manufacturers should publish the halal ingredients used and provide a formal statement on the halal certification application.

Source: Sekretariat Kabinet Republik Indonesia (SETKAB)

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