II. REGISTRATION OF HEALTH SUPPLEMENTS IN INDONESIA
(i) Type of registration
The responsible authority is the Indonesian Food and Drug Authority (BPOM). In order for food and drugs to be imported and commercialized a circulation permit [import license] and compliance with the rules on import is required (Regulation 28 (2023) on Importation Control of Food and Drugs Into The Territory of Indonesia). Only the holder of a circulation permit may import drugs or food, including Health Supplement. The approval is called a SKI, being an import notification letter.
The requirements regarding registration of Health supplements are further implemented by BPOM Regulation No 32 of 2022 concerning Criteria and Procedures for Health Supplement Registration and amendments in BPOM Regulation 15 of 2024 concerning Amendments to the Regulation No 32 of 2022 about Criteria and Procedures for Health Supplement Registration.
(ii) Applicant
- A distinction is made between applicants of domestic and imported food supplements. For imported health supplements, the registration must be completed by a local agent. The registration of imported health supplements requires requires an appointment letter from the manufacturer in the country of origin to the food business entity responsible for marketing the product in Indonesia.
- The local entity needs to possess an importer license in the pharmaceutical preparation sector.
- The foreign manufacturer needs to possess GMP-certification issued by the authorities of the country of origin or an accredited institution. Additional in-situ examination may be conducted by the Indonesian BPOM.
(iii) Procedure
Registrations can be completed in Bahasa Indonesia and / or English. The documentation may be provided in either language.
Different categories of registration apply depending on the composition of the health supplement or changes that are made to an existing registration.
The registration needs to be presented with the head of the Indonesian Food and Drug Authority (BPOM) and consists of two phases;
- Pre-assessment. this step comprises an evaluation of the submitted documentation (i.e., whether the forwarded documents are complete and valid) and the determination of category for registration (category 1 to 4).
- Assessment. The actual assessment consists of the evaluation of the provided documentation and supporting data. All data used in the registration is kept confidential.
The required documentation Includes:
• Import license of local agent (importer)
• Letter of authorization (from foreign manufacturer to local agent)
• Certificate of free sale from country of origin or Certificate of Pharmaceutical Product
• GMP of manufacturer in accordance with the dosage form imported from the government authority in the country of origin
• Composition: ingredients and actives
• Manufacturing Procedure
• Information on the source of Raw Material and quality assessment methods of raw material
• Packaging specification
• Quality Assessment Method of Finished product
• Stability study reports (at least 2 batches at a temperature of 30 ± 2ºC
RH 75 ± 5%)
• Information on the origin of ingredients, such as source of gelatin, halal certificate and BSE free certificate
• Safety information such as toxicity test reports for new/unknown ingredients
• Efficacy study report for products with unknown efficacy
• Label, according to Annex 1 of Regulation No 32 (2022) concerning Criteria and Procedures for Health Supplement Registration
(iv) Time limit
It is estimated that 60 days should be counted for the registration of health supplements. This excludes the ‘stop clock’ time for request of supplementary documents/clarification to support the evaluation.
(v) Payment
- Fee applies determined according to statutory documents.
(vi) Outcome
- Either compliance or (provisional) incompliance regarding quality, safety and efficacy shall be awarded. In case of compliance a decision letter by the Agency Head will be issued. Different sizes of one product are covered under a single registration. The same accounts for different flavors of one product.
- In case of provisional incompliance, additional data will be requested. The data needs to be forwarded within three months from the date of the notice. If the time-limit is exceeded the dossier is returned by email. In that case a new registration will have to be initiated.
- The registration remains valid for a period of 5 years. Authorization belongs to the local agent and cannot be awarded to other distributors, apart from when a different registration is completed. Extension of the circulation permit can be obtained through re-registration.
- Refusal means that the products need to be re-registered and the fees need to be paid again.
The product must be imported or manufactured within one year of approval. Additionally, during the 5-year validity period of the license, the product must not cease manufacturing or importation for two consecutive years. Failure to comply with these requirements may result in sanctions, including the cancellation of the license.
