INDONESIA Law and Practice Contributed by: Wincen Santoso, Muhammad Pravest Hamidi, Daniel Wiyarta Tenggara and Rizka Rahma Briliana, Santoso, Martinus & Muliawan Advocates
reports or import reports to the BPOM. They are also obliged to monitor the efficacy, safety and quality of the drug and report the result to the BPOM. Such data can trigger the BPOM to con- duct a drug reassessment, which can result in: • change of label; • revision of composition/formula; • provision of limitation of use; • change in classification of the drug; • withdrawal of the drug from circulation; • suspension or revocation of the marketing authorisation. Medical Devices Manufacturers and distributors of medical devic- es or in vitro diagnostic medical devices that will be distributed must include markings and information on the medical devices in accord- ance with laws and regulations. The information that must be provided includes safety, useful- ness, instructions for use, and/or other neces- sary information, such as trade name, market- ing authorisation number, product specification, expiration date and – if applicable – “For Profes- sional Use Only” warning label. Additionally, if applicable, information on net content, composition and levels of active ingre- dients, contraindications, cautions and warning signs or serious adverse events/side effects must be included in the marking and informa- tion. The marking and information are prohibited from including certain contents – for example, using superlative words such as “very” , “top” and “super” and mentioning the name of the test lab. Holders of a marketing authorisation must sub- mit reports including production reports or dis- tribution reports to the MOH. They must also
submit an adverse event report if an adverse event occurs. Manufacturers and distributors of medical devic- es and in vitro diagnostic medical devices must supervise their products and ensure conformity to standards of quality, safety, and usefulness. The supervision can take the form of audit, re- examination of products to determine serious adverse events, and reporting serious adverse events to the government. 3.7 Third-Party Access to Pending Applications for Marketing Authorisations for Pharmaceuticals and Medical Devices Information relating to pending applications for marketing authorisations both for pharmaceuti- cals and medical devices is not made available to, and thus cannot be accessed by, third par- ties. Specifically with regard to pharmaceuticals, Article 27(4) of H.BPOM 24/2017 as amended provides that any information submitted to the BPOM for the purpose of applying for market- ing authorisation is strictly confidential and may only be used solely for evaluation purposes by authorised parties. The BPOM provides a website where third par- ties can access information concerning the sta- tus of marketing authorisations (ie, whether the said authorisation is active, suspended, or has been revoked). Article 1(9) of BPOM 8/2024 and Article 1(6) of MOH 63/2017 affirm that the confidentiality of information relating to individuals participating in clinical trials of pharmaceuticals and medical devices is an integral part of the Good Clinical Practice standard, which must be adhered to when conducting clinical trials. Additionally, the Appendix to BPOM 8/2024 and the Appendix to MOH 63/2017 further clarify that clinical tri-
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