INDONESIA Law and Practice Contributed by: Wincen Santoso and Muhammad Pravest Hamidi, Santoso, Martinus & Muliawan Advocates
3.6 Ongoing Obligations Imposed by Marketing Authorisations Pharmaceuticals
Variation in the marketing authorisation must be con- ducted in the event there is a variation in: • the size, packaging or marking of the product; • accessories/attachments to the marketing authori- sation; or • the name or address of the representative author- ised by the manufacturer. If there are variations other than the foregoing, the marketing authorisation holder must apply for a new marketing authorisation. Applications for a variation in the marketing authorisa- tion for medical devices are submitted online through the RBA OSS system and MOH electronic system and fulfil administrative and technical requirements. 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations In principle, medical devices and in vitro diagnos- tic medical devices that are produced, imported, assembled, and/or repackaged must have a market- ing authorisation to be distributed within Indonesia. However, MOH 62/2017 provides specific exemptions to this requirement: • medical devices that enter Indonesia through a special access scheme (SAS) in accordance with laws and regulations; • certain medical devices and in vitro diagnostic medical devices produced by household compa- nies; and/or • medical devices and in vitro diagnostic medical devices for certain reasons determined by the MOH. Pharmaceuticals that enter Indonesia through the SAS in accordance with laws and regulations are exempted from the requirement for a marketing authorisation. In the event of a public health emergency, the market- ing authorisation may be in the form of an emergency use authorisation (EUA), which is only effective for use of drugs during the public health emergency and for patient medications in accordance with laws and regulations.
A holder of a marketing authorisation for pharmaceuti- cals is required to submit production reports or import reports to the BPOM. They are also obliged to monitor the efficacy, safety and quality of the drug and report the results to the BPOM. Such data can trigger the BPOM to conduct 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; or • suspension or revocation of the marketing authori- sation. Further, ongoing obligations under BPOM 27/2025 include: • complying with the Indonesian pharmacopoeia standards set by the Minister of Health and/or BPOM; • guaranteeing the safety, efficacy, quality, and label- ling of the drug and conducting pharmacovigilance monitoring and reporting of drug side effects to the Head of BPOM; and • producing or importing the drug no later than one year from the date of the marketing authorisation. Medical Devices Manufacturers and distributors of medical devices or in vitro diagnostic medical devices that will be distrib- uted must include markings and information on the medical devices in accordance with laws and regula- tions. The information that must be provided includes safety, usefulness, instructions for use, and/or other necessary information, such as trade name, marketing authorisation number, product specification, expira- tion date and – if applicable – a “For Professional Use Only” warning label. Additionally, if applicable, information on net content, composition and levels of active ingredients, con- traindications, cautions and warning signs or serious adverse events/side effects must be included in the
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