INDONESIA Law and Practice Contributed by: Wincen Santoso, Muhammad Pravest Hamidi, Daniel Wiyarta Tenggara and Rizka Rahma Briliana, Santoso, Martinus & Muliawan Advocates
7.5 Trade Blocs and Free Trade Agreements
or surveyor report under the MOT 36/2023 as amended. BPOM 27/2022 as amended provides that phar- maceuticals without marketing authorisation may be imported into Indonesia for certain pur- poses, such as: • personal use; • research; • product and/or scientific development; • donation; • sample for marketing authorisation applica- tions; • clinical trials for registration requirements, product development, and/or scientific pur- poses; • government programmes; • urgent national interests; • special use for healthcare services that can- not be produced domestically; and • exhibitions. MOH 14/2021 provides that the MOH may issue statement letters addressed to the Indonesian customs to explain that the imported products are raw materials, spare parts, or samples that will be used for the purpose of applying for mar- keting authorisation. Further, 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 Indo- nesia 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 amended by MOF Regulation No 10 of 2024.
Indonesia is a member of the Association of Southeast Asian Nations (ASEAN) and the fol- lowing free trade agreements that contain pro- visions on trade/regulatory facilitation. Three notable examples include: • the ASEAN Trade in Goods Agreement (ATIGA); • the ASEAN–Australia–New Zealand Free Trade Agreement (AANZFTA); • the Regional Comprehensive Economic Part- nership (RCEP). 8. Pharmaceutical and Medical Device Pricing and Reimbursement 8.1 Price Control for Pharmaceuticals and Medical Devices Pharmaceuticals The prices for pharmaceuticals in Indonesia are regulated to ensure affordability and accessibil- ity, primarily 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 formula, depend- ing 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 high- est retail price must be in the form of a nomi- nal value. The highest retail price is 128% of the HNA ( harga netto apotek , or pharmacy net price), which is the price given by the pharma- ceutical wholesaler to the pharmacies plus VAT.
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