Halal certificate requirement for pharmaceuticals and medical products
ADCO Law
ADCO Law
A presidential instruction was recently issued to implement the Halal Certification requirement for all pharmaceutical products, biological products, and medical devices circulating in Indonesia. Thailand exporters should take note of this mandatory certification, as it constitutes a new procedure for exporting to the Indonesian market.
A. Overview
President Joko Widodo issued Presidential Regulation No. 6 of 2023 on Halal Certification of Medicines, Biological Products, and Medical Devices that implement on January 19, 2023 (“PR 6/2023”).
Pursuant to PR 6/2023, the products that must be halal certified consists of:
a. Pharmaceutical product (except for any narcotics and psychotropics);
b. Biological product (e.g. enzymes, vaccines); and
c. Medical device that is made from or contains animal elements.
The Halal Certificate will be issued by the Halal Products Guarantee Organizer (Badan Penyelenggara Jaminan Produk Halal – “HPGO”) to the products which are qualified according to Islamic Law with following criteria:
a. made from halal ingredients; and
b. made through halal manufacturing methods in accordance with Islamic Law.
Therefore, the imported products that are intended to be circulated in Indonesia and are already halal certified are not obligated to apply for Indonesian Halal Certificate only if the halal certificate is issued by a foreign institution that has entered a mutual recognition partnership with the Indonesian government. Such products shall be registered by HPGO before circulating in Indonesia.
B. Conclusion
We recommend that Thailand companies who export halal products in Indonesia shall apply for Halal Certificate before circulating their products in Indonesia to ensure compliance. Medical products and pharmaceuticals are subject to a risk-based system for licensing, and any additional costs and time incurred should be calculated and incorporated into a Thailand company’s business plan in this regard.
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