Standards and Regulations

To ensure public medication safety and prevent drugs that do not meet Indonesian safety and quality standards from entering the market, the Indonesian government has established...Drug registration and approval evaluation systemDrugs must undergo approval before they can be distributed and circulated within the country. This regulatory system is overseen by the Indonesian Food and Drug Administration (Badan Pengawas Obat dan Makanan, abbreviated as...).BPOMUnified management.

I. Core Regulations for Imported Drugs and Distribution Licensing

1. Definition of imported drugs

   According to Article 1, Paragraph 36 of BPOM Regulation No. 24/2017, imported medicines refer to...Overseas pharmaceutical companies produceMedicines intended for distribution in Indonesia, either as finished products or in bulk, with primary packaging.

2. 
   

3. Distribution license is mandatory

   Pursuant to section 2 of BPOM Regulation No. 27/2022,All pharmaceuticals intended for distribution in Indonesia must obtain a distribution license.And it complies with the requirements of current laws and regulations.

II. Requirements and Standards for Applying for Distribution Licenses

1. Safe and effectiveThe efficacy and safety have been confirmed through non-clinical trials, clinical trials, or the latest scientific evidence.

2. Quality ComplianceIt meets the established quality standards, and the production process complies with...Good Manufacturing Practice (CPOB) for PharmaceuticalsAnd it has valid supporting documentation;

3. Information StandardsProduct information and label content are objective and unmisleading, ensuring the rational and safe use of medicines.

III. Eligibility of License Applicants

1. Imported drug registrationLimitedObtain written authorization from overseas pharmaceutical companiesPharmaceutical companies in Indonesia(Except for cases where the registrant is an affiliated company of the parent company);

2. Overseas manufacturers must holdDrug Production LicenseAnd in compliance with the local authoritiesGood Manufacturing Practice (CPOB) for PharmaceuticalsRequire;

3. Imported medicinesDistribution license holders or their authorized agents onlyConduct distribution activities.

IV. New Drug Registration Process

New drug registration is divided intoTwo stages：

1. Pre-registration phase

   The registrant submits a written application to the Director of the BPOM, pays the relevant fees, and completes the preparation of the pre-registration documents;

1. Formal registration phase

   The registrant fills out the registration form and submits the application along with a complete set of required documents, including: management documents, quality documents, non-clinical documents, and clinical documents.

V. Circumstances under which imported drugs are exempt from distribution licenses

• For personal use only;

• Scientific research and product development;

• Donated supplies;

• Samples for registration/license application;

• Drugs for clinical trials (meeting registration and research and development requirements);

• Government projects; safeguarding national emergency interests;

• Special medical drugs that cannot be produced domestically;

• Medicines for exhibition and display.

Exemption from core import requirements

• drugStrictly prohibited for sale；

• Import quantities must match actual demand;

• Must passSpecial access mechanismHandling import customs clearance.

Detailed Exemption Scope

1. Research, product development, non-market testing, exhibitions: applicable to pharmaceuticals, traditional medicines, health products, quasi-pharmaceuticals, processed foods, and cosmetics;

2. Donations are only permitted for pharmaceuticals, traditional medicines, health supplements, quasi-pharmaceuticals, and processed foods.

3. Clinical trials, national emergency interests, and special medical uses: These apply only to drugs, traditional medicines, health products, quasi-drugs, and processed foods that claim to reduce the risk of disease.

4. Exhibition: Applicable to traditional medicines, quasi-medicines, health products, cosmetics, and processed foods.

VI. Legal Consequences of Unlicensed Import and Distribution