INDONESIA Law and Practice Contributed by: Wincen Santoso and Muhammad Pravest Hamidi, Santoso, Martinus & Muliawan Advocates
• the marketing authorisation owner committing a violation in the field of production, distribution, 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 authorisation 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 being revoked; • the medical device distribution licence being revoked; or • termination of appointment as sole agent/sole dis- tributor/exclusive distributor and/or authorisation. 3.4 Procedure for Obtaining a Marketing Authorisation Pharmaceuticals To obtain a marketing authorisation for pharmaceuti- cals, the registration process must be conducted with the BPOM through the Risk-Based Approach Online Single Submission (RBA OSS) system. Only pharma manufacturing companies established in Indonesia can apply for registration. The registration process for new products is classified into three categories: • Category 1 covers new drugs and biological prod- ucts, including biosimilars. • Category 2 covers generic drugs and branded generic drugs. • Category 3 covers other drug-containing products with special technology (eg, transdermal patches, implants and beads). For new product registration of category 1, risk man- agement planning is mandatory. The procedures 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, variations that have a significant effect on the efficacy, safety and/or quality of the drug. • Category 5 covers minor variations – ie, variations that do not fall under the category of either major variation or notification variation registration. • Category 6 covers notification variations – ie, varia- tions that have minimal or no effect on the efficacy, safety and/or quality of the drug. The registration process for the foregoing generally 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 category, evaluation track, evaluation fee, and required documents. Medical Devices Applications to obtain marketing authorisations for medical devices and in vitro diagnostic medical devices are submitted online through the RBA OSS system and the MOH electronic system. The applica- tion requires, among other things, the submission of administrative and technical requirements, including a certificate of production/medical device distribution licence, certificate of free sale, quality management system document, and product information. The MOH then evaluates and verifies the administra- tive and technical requirements of the application. If the medical devices involve new technology, active substances, or uncommon claims, a review by a des- ignated expert team may be required. If the administrative and technical requirements are fulfilled and the documents are complete, the mar- keting authorisation is issued electronically within a specified timeframe. Otherwise, the MOH will issue a refusal letter. If additional information is required, the MOH will notify the applicant to provide the necessary details or documents.
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