28 November, 2017
The promotion of drugs in Indonesia is highly regulated. The Food and Drugs Supervisory Agency or Badan Pengawas Obat dan Makanan or (BPOM) has issued a new guideline on the advertising of drugs, ie, Decision of the Head of BPOM No.8 Year 2017 on Supervision Guidelines on the Advertising of Drugs (BPOM Decision No.8). BPOM Decision No.8 sets out the guidelines on the advertising of prescription drugs and non-prescription drugs.
General Rules
Based on BPOM Decision No.8, prescription drugs may only be advertised in the medical scientific printing media (media cetak ilmiah kedokteran) or scientific pharmaceutical printing media (media cetak ilmiah farmasi). Only non-prescription drugs (obat bebas) and limited non-prescription drugs (obat bebas terbatas) can be advertised to the public through printing media, electronic media and outdoor media, subject to certain limitations allowed by the prevailing regulations.
Requirements
The 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 objective, comprehensive and not misleading information.
Further, the information should be in accordance with the information stated in the marketing authorization. The non-prescription drugs (obat bebas) and limited non-prescription drugs (obat bebas terbatas) can be advertised if the drugs have already obtained the 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.
In addition, the advertisements should be made in Bahasa Indonesia. However, they also can be done in local Indonesian languages. The English language can be used if there is also a Bahasa Indonesia translation.
Term
The advertising approval is valid until the expiry of the marketing authorization provided that the advertisement still complies with the requirements.
Prohibitions
BPOM Decision No. 8 prohibits each person to:
- Publish advertisements which have not been approved by BPOM
- Publish advertisements which are not in accordance with the advertising approval
- Do advertising through social media
Supervisions
BPOM has authority to supervise drug advertisements. Further, BPOM may evaluate the advertising approval.
Further, BPOM may (i) request an adjustment of an advertisement; or (ii) revoke the advertising approval.
Sanctions
Under BPOM Decision No. 8, parties who violate the provisions will be imposed with administrative sanctions, including:
- Ceasing the publication of the advertisement
- Ceasing the advertisement activities for the particular products within six months
- Revocation of marketing authorization
For further information, please contact:
Cahyani Endahayu, Partner, Baker & McKenzie
cahyani.endahayu@bakermckenzie.com
