The promotion of drugs in Indonesia is highly regulated, and the Food and Drugs Supervisory Agency or Badan Pengawas Obat dan Makanan (BPOM) has issued a new guideline on the advertising of drugs, i.e. Decision of the Head of BPOM No. 8 (2017) on Supervision Guidelines on the Advertising of Drugs.
BPOM Decision No.8 sets out the guidelines on the advertising of prescription drugs and non-prescription drugs.
Based on BPOM Decision No.8, prescription drugs may only be advertised in the medical scientific print media or scientific pharmaceutical print media. Only non-prescription drugs and limited non-prescription drugs can be advertised to the public through print media, electronic media and other media, subject to certain limitations allowed by the prevailing regulations.
Drug advertisements should fulfill the requirements of being objective, comprehensive and not misleading. BPOM Decision No. 8 sets out a specific explanation of what is meant by information that is objective, comprehensive and also not misleading.
The information should also be in accordance with the information stated in the marketing authorization. Non-prescription drugs and limited non-prescription drugs can be advertised if the drugs have already obtained marketing authorizations, and the contents of the advertisements should also be approved by BPOM before the advertisements are launched. However, the advertisements can be launched without the approval of BPOM if the advertisements only contain information on the product name and the pharmaceutical manufacturing company name.
The advertisements should be made in Bahasa Indonesian. However, but they also can be done in other local Indonesian dialects. The English language can be used if there is also a Bahasa Indonesia translation.
The advertising approval is valid until the expiry of the marketing authorization, provided that the advertisement still complies with the requirements.
BPOM Decision No. 8 prohibits:
- publishing advertisements that have not been approved by BPOM;
- publish advertisements that are not in accordance with advertising approval;
- advertising through social media.
BPOM has the authority to supervise drug advertisements, may evaluate the advertising approval, and may also: (1) request an adjustment of an advertisement; or (2) revoke the advertising approval.
Business Law Digest is compiled with the assistance of Baker McKenzie. Readers should not act on this information without seeking professional legal advice. You can contact Baker McKenzie by emailing Danian Zhang at firstname.lastname@example.org.