INDONESIA Law and Practice Contributed by: Wincen Santoso and Muhammad Pravest Hamidi, Santoso, Martinus & Muliawan Advocates
7.2 Importer of Record of Pharmaceuticals and Medical Devices Any legal entity with a valid import business licence can act as the importer of record for pharmaceuticals and medical devices. However, the import of certain products requires specific documents issued by the relevant authorities (see 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices ). 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices Devices The import of pharmaceuticals and medical devices requires marketing authorisation of the products (see 3.5 Access to Pharmaceuticals and Medical Devic- es Without Marketing Authorisations ). The import of pharmaceuticals also requires an import certificate (surat keterangan impor, or SKI) from the BPOM. Addi- tionally, certain products require an import approval and/or surveyor report under the MOT 16/2025 as amended and MOT Regulation No 23 of 2025. BPOM 27/2022 as amended provides that pharma- ceuticals without marketing authorisation may be imported into Indonesia for certain purposes, such as: • personal use; • research; • product and/or scientific development; • donation; • sample for marketing authorisation applications; • clinical trials for registration requirements, product development, and/or scientific purposes; • government programmes; • urgent national interests; • special use for healthcare services that cannot be produced domestically; and • exhibitions. MOH 14/2021 provides that the MOH may issue state- ment letters addressed to the Indonesian customs to explain that the imported products are raw materi- als, spare parts, or samples that will be used for the purpose of applying for marketing authorisation. Fur- ther, please note that – in importing such products – a statement letter from the MOT may also be required.
7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports Non-tariff regulations and restrictions in Indonesia are imposed based on the harmonised system (HS) codes of the goods. The types of products subject to non-tariff regulations and restrictions are listed in the Ministry of Finance (MOF) regulation – specifically, MOF Regulation No 26/PMK.010/2022 of 2022, as last amended by MOF Regulation No 62 of 2025. 7.5 Trade Blocs and Free Trade Agreements Indonesia is a member of the Association of Southeast Asian Nations (ASEAN) and the following free trade agreements that contain provisions on trade/regula- tory facilitation. Three notable examples include: • the ASEAN Trade in Goods Agreement (ATIGA); • the ASEAN–Australia–New Zealand Free Trade Agreement (AANZFTA); and • the Regional Comprehensive Economic Partner- ship (RCEP). 8. Pharmaceutical and Medical Device Pricing and Reimbursement 8.1 Price Control for Pharmaceuticals and The prices for pharmaceuticals in Indonesia are regu- lated to ensure affordability and accessibility, primar- ily governed by MOH 98/2015. Under this regulation, pharma industries are required to provide information on the highest retail price on the drug’s label – either as a nominal value in Indonesian rupiah or as a for- mula, depending on the type of drug. This regulation covers generic drugs listed in the e-catalogue for gov- ernment procurement, generic drugs not listed in the e-catalogue, and drugs other than generic drugs. For generic drugs not listed in the e-catalogue and drugs other than generic drugs, the highest retail price must be in the form of a nominal value. The highest retail price is 128% of the HNA ( harga netto apotek , or pharmacy net price), which is the price given by the pharmaceutical wholesaler to the pharmacies plus VAT. For generic drugs listed in the e-catalogue, the Medical Devices Pharmaceuticals
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