New BPOM Regulation on Health Supplements

The Drug and Food Supervisory Agency (Badan Pengawas Obat dan Makanan – “BPOM”) has revised Regulation of BPOM No. 32 of 2022 on the Criteria and Procedures for the Registration of Health Supplements, as amended by Regulation No. 15 of 2024 (collectively referred to as “PerBPOM 32/2022”). Several clauses have been amended, including clauses regarding the simplification of administrative documents, the validity period of distribution license, and the maximum limits for vitamins and minerals.

“This regulation serves as an important basis for the surveillance system for pre-market and post-market of health supplements. The adjustments were made to ensure continued relevance and responsiveness to business actors’ needs while remaining aligned with international standards,” stated Dian Putri Anggraweni, the Director of Standardization of Traditional Medicines, Health Supplements, and Cosmetics (Obat Tradisional, Suplemen Kesehatan, dan Kosmetik/OTSKK).

Referring to the Draft BPOM Regulation on the Criteria and Procedures for the Registration of Health Supplements (“RPerBPOM”) obtained by Hukumonline, Article 14 (3) and (4) regulate the submission of applications for registration of distribution license by business actors.

Meanwhile, Article 15 regulates the exemptions from the distribution license requirement for health supplements intended for specific uses. In addition, Article 17 clarifies the registration applications, which include domestic registration, export, and import.