Additional Obligations for Health Supplement Importers

The National Agency of Drug and Food Control (“BPOM”) will require health supplement importers to attach a number of additional documents as a condition of registration. This is regulated in the draft amendment to Regulation of BPOM No. 32 of 2022 on Criteria and Procedures for Registration of Health Supplements, as amended by Regulation of BPOM No. 15 of 2024 (collectively referred to as “Regulation 32/2022”).

“In relation to import registration, matters that were not previously regulated in the current Regulation are also regulated. Namely, provisions for imported health supplements that are not distributed in the country of production,” said Erni Rahmawati, Chair of the Health Supplement and Quasi-Drug Standards Drafting Team.

These include a letter from the manufacturer explaining that the imported health supplement is not distributed in the country of production, accompanied by information on the country of export. Then, a Certificate of Free Sale (“CFS”), Certificate of Pharmaceutical Product (“CPP”), or other equivalent documents that are still valid from the country of origin must be attached.

In relation to the provisions for imported health supplements produced under contract in the country of origin, importers must attach a document detailing the production contract agreement between the principal and the manufacturer in the country of origin, which must have a certificate of good manufacturing practices. This certificate must be equivalent to the Good Manufacturing Practices for Herbal Medicines (“CPOBAB”) applicable in Indonesia.