Importing Drugs into Indonesia: Registration and Distribution Licence Management

To safeguard public medication safety and prevent drugs that do not meet Indonesia's safety and quality standards from entering the market, the Indonesian government has established a drug registration review and approval system : drugs may only be distributed within the country after completing the approval process. This regulatory system is administered by the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan, BPOM ). 1. Core Rules on Imported Drugs and Distribution Licences Definition of imported drugs Under Article 1(36) of BPOM Regulation No. 24/2017, an imported drug is a drug produced by an overseas pharmaceutical manufacturer , in finished or bulk form with primary packaging, intended for distribution within Indonesia. Mandatory distribution licence Under Article 2 of BPOM Regulation No. 27/2022, all drugs intended for distribution within Indonesia must obtain a distribution licence and comply with applicable laws and regulations. 2. Requirements and Standards for Obtaining a Distribution Licence A drug must meet all of the following standards to obtain a distribution licence: Safe and effective : through non-clinical trials, clinical trials or the latest scientific evidence, demonstrating clear efficacy and adequate safety; Quality-compliant : meeting established quality standards, with a production process conforming to Good Manufacturing Practice for drugs (CPOB) and supported by valid documentation; Compliant information : product information and labelling that are objective and not misleading, ensuring rational and safe use of the drug. 3. Eligibility of the Licence Applicant Registration of imported drugs is limited to an Indonesian pharmaceutical company with written authorisation from the overseas manufacturer (except where the registrant is an affiliate of the parent company); The overseas manufacturer must hold a drug manufacturing licence and meet the Good Manufacturing Practice for drugs (CPOB) requirements of its local authority; Imported drugs may only be distributed by the holder of a distribution licence or its authorised agent . 4. New Drug Registration Process New drug registration is divided into two stages : Pre-registration stage The registrant submits a written application to the Head of BPOM, pays the relevant fees, and prepares the pre-registration documents; Formal registration stage The registrant completes the registration form and submits the application with a full set of required documents, including: administrative documents, quality documents, non-clinical documents and clinical documents. 5. Imported Drugs Exempt from a Distribution Licence Imported drugs must in principle be distributed under a licence, but drugs for specific uses may be exempted , including: Personal use Scientific research and product development Donated supplies Samples for registration / licensing applications Drugs for clinical trials (meeting registration and R&D needs) Government programmes and safeguarding the national emergency interest Special medical drugs that cannot be produced domestically Drugs for exhibition and display Core requirements for exempt imports The drug must not be used for sale ; The import quantity must match actual need; Import clearance must go through a special access mechanism . Detailed scope of exemptions Research, product development, non-market testing, exhibition: applies to drugs, traditional medicines, health supplements, quasi-drugs, processed food and cosmetics; Donation: applies only to drugs, traditional medicines, health supplements, quasi-drugs and processed food; Clinical trials, national emergency interest, special medical use: applies only to drugs, traditional medicines, health supplements, quasi-drugs and processed food that claim to reduce disease risk; Exhibition: applies to traditional medicines, quasi-drugs, health supplements, cosmetics and processed food. 6. Legal Consequences of Unlicensed Import and Distribution Distributing imported drugs without a distribution licence, or violating the rules on unlicensed import for specific uses, will incur administrative penalties under the law.