INDONESIA Law and Practice Contributed by: Wincen Santoso, Muhammad Pravest Hamidi, Daniel Wiyarta Tenggara and Rizka Rahma Briliana, Santoso, Martinus & Muliawan Advocates
• violation of the obligation to make and send a production report or import report of imported drugs to the BPOM in accordance with laws and regulations; • revocation of the industrial licence of the mar- keting authorisation owner; or • the marketing authorisation owner committing a violation in the field of production, distribu- tion, promotion, and/or drug labelling. Medical Devices Marketing authorisation for medical devices is issued with a maximum validity period of five years. Renewal of marketing authorisation for a medical device must be submitted no earlier than nine months before the current authorisa- tion expires. Marketing authorisation for medical devices can be revoked in the event of: • the medical devices causing consequences that may endanger health; • the medical devices not meeting the criteria in accordance with the data submitted at the time of the application for the marketing authorisation registration; • the product certificate is revoked; • the medical device distribution licence is revoked; or • termination of appointment as sole agent/ sole distributor/exclusive distributor and/or authorisation. 3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and To obtain a marketing authorisation for pharma- ceuticals, the registration process must be con- ducted with the BPOM through the Risk-Based Approach Online Single Submission (RBA OSS) system. Only pharma manufacturing companies Medical Devices Pharmaceuticals
established in Indonesia can apply for registra- tion. The registration process for new products is classified into three categories: • category 1 covers new drugs and biological products, including biosimilars; • category 2 covers generic drugs and branded generic drugs; and • category 3 covers other drug-containing products with special technology (eg, trans- dermal patches, implants and beads). For new product registration of category 1, risk management planning is mandatory. The pro- cedures and requirements for registration are outlined in H.BPOM 24/2017 as amended. The registration process for variation is classified into three categories: • category 4 covers major variations – ie, vari- ations that have a significant effect on the efficacy, safety and/or quality of the drug; • category 5 covers minor variations – ie, vari- ations that do not fall under the category of either major variation or notification variation registration; and • category 6 covers notification variations – ie, variations that have minimal or no effect on the efficacy, safety and/or quality of the drug. The registration process for the foregoing gen- erally consists of two stages – namely, the pre- registration phase and the registration phase. The pre-registration phase filters the registration process by determining the registration catego- ry, evaluation track, evaluation fee, and required documents.
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