INDONESIA Law and Practice Contributed by: Wincen Santoso, Muhammad Pravest Hamidi, Daniel Wiyarta Tenggara and Rizka Rahma Briliana, Santoso, Martinus & Muliawan Advocates
3. Marketing Authorisations for Pharmaceuticals or Medical Devices 3.1 Product Classification: Pharmaceuticals or Medical Devices Under Law 17/2023, medical devices are defined as instruments, apparatus, machines, equip- ment, implants, in vitro reagents and calibrators, software, and materials or similar that are used on humans for medical purposes and do not achieve their primary action through pharmaco- logical, immunological, or metabolic processes. In contrast, drugs are defined as substances or mixtures thereof (including biological products) that are intended for human consumption to influence or examine physiological systems or pathological conditions for the purposes of diag- nosis, prevention, treatment, recovery, health improvement, and contraception. 3.2 Granting a Marketing Authorisation for Biologic Medicinal Products Biological products (eg, vaccines) fall within the definition of drugs and thus fall under the same regulations. 3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Marketing authorisation for pharmaceuticals is issued with a maximum validity period of five years. Renewal of marketing authorisation for a pharmaceutical must be submitted no earlier than 12 months and no later than two months before the current authorisation expires. Market- ing authorisations for pharmaceuticals can be suspended and/or revoked in the event of: Medical Devices Pharmaceuticals
Additionally, Article 1(9) of BPOM 8/2024 and Article 1(6) of MOH 63/2017 affirm that the con- fidentiality of information relating to individuals participating in clinical trials of pharmaceuticals and medical devices is part of the Good Clini- cal Practice standard ( Cara Uji Klinis Yang Baik ), which must be complied with in conducting clini- cal trials. 2.6 Databases Containing Personal or Sensitive Data Under Law 27/2022, the creation of a database containing personal information requires the explicit consent of the data subject. Further, GR 28/2024 provides that health infor- mation system providers must store health data and health information in a database that is located in a safe place and is not damaged or easily lost by using electronic and/or non-elec- tronic storage media. These databases may uti- lise servers, cloud computing systems, or other storage media in accordance with technological development. Such database must be hosted in a data centre located within the territory of Indonesia. Although storage services and facili- ties owned by a third party may be used, such arrangements must adhere to the following con- ditions: • the storage must be implemented within Indonesia’s jurisdiction; • a formal co-operation agreement must be in place, which contains at least provisions on confidentiality, service level, and service level target; • the health data and information are owned and fully controlled by the health information system provider; and • the data processor must fulfill all data proces- sor obligations under Indonesian law.
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