Regulation Watch · Tourism and Health · Indonesia. The four regulations apply nationally to BPOM registration and market authorization for quasi-drugs, natural medicines, health supplements and cosmetics produced in or imported into Indonesia.
BPOM Replaces Four Product Registration Frameworks
PerBPOM 17-20/2026 replace Indonesia's registration rules for quasi-drugs, natural medicines, health supplements and cosmetics, with immediate filing controls and 12-month or two-year transition duties.
- Published
- BPOM established Regulations 17, 18, 19 and 20 of 2026 on 23 October 2026. They were promulgated on 3 November 2026 in State Bulletin Nos. 750, 751, 752 and 753 and were added together to BPOM's official sector regulation index on 5 November 2026.
- Effective
- 3 November 2026, the promulgation date stated by the four regulations. Each regulation applies from promulgation and replaces the prior product-specific registration or notification rule.
- Added to Watch
- 6 November 2026
Who is affected
PT PMA and PT PMDN manufacturers, importers, brand owners, licence holders, marketing companies, contract manufacturers, distributors and retailers of quasi-drugs, natural medicines, health supplements and cosmetics; foreign principals and manufacturers; directors, commissioners and shareholders; and regulatory, quality, safety, supply-chain, legal and product teams responsible for BPOM filings and post-market compliance.
Practical impact
The package replaces the previous registration rules for all four product groups. PerBPOM 17-19/2026 set the applicant, manufacturing, contract, licensing, import, agency, technical-file, labeling, evaluation, variation and renewal conditions for quasi-drugs, natural medicines and health supplements. Their market authorizations are generally valid for up to five years, while imported-product validity can be shorter when the agency appointment expires earlier. Licence holders must monitor safety, efficacy or benefit, quality and labeling, maintain pharmacovigilance, retain required samples and recall and report nonconforming products. PerBPOM 20/2026 requires a cosmetic Product Information File before notification, restricts one cosmetic name to one applicant except qualifying related companies, allows one notification across specified facilities or contracts subject to strict identity and quality controls, and limits a notification owner to no more than three contract manufacturers under that route. Cosmetic notifications are valid for up to three years. Existing pending applications continue under the former rules, but existing files, recommendations and foreign contract arrangements now have fixed transition periods.
BPOM established Regulations 17, 18, 19 and 20 of 2026 on 23 October. They were promulgated on 3 November in State Bulletin Nos. 750 through 753 and took effect that day. BPOM's product-standard directorate added the four signed texts to its official regulation index together on 5 November.
PerBPOM 17/2026 replaces the 2023 quasi-drug registration rule, PerBPOM 18/2026 replaces the 2023 natural-medicine registration rule, and PerBPOM 19/2026 replaces the 2022 health-supplement registration rule as amended in 2024. The new texts govern domestic, contract, licensed, export and import routes as applicable, together with applicant eligibility, technical files, good-manufacturing evidence, agency appointments, importer recommendations, evaluation, variations and renewals.
A market authorization under the three registration rules is generally valid for up to five years, although an imported product can receive a shorter term where the foreign principal's agency appointment expires earlier. A product that is still marketed needs a timely renewal. The rules also support risk-based evaluation and allow BPOM to reassess a circulating product, require labeling or formulation changes, restrict use, order withdrawal, suspend activity or take action against the authorization.
The licence holder remains responsible after approval. It must monitor safety, efficacy or benefit, quality and labeling, conduct pharmacovigilance, keep required retained samples and recall and report a nonconforming product. The natural-medicine and health-supplement rules expressly permit revocation where production or import does not begin within one year after authorization or stops for two consecutive years after the last production or import, subject to BPOM's risk assessment.
The transition is operationally important. Applications filed before 3 November continue under the former rules, and existing authorizations remain valid until expiry. Where an existing quasi-drug, natural medicine or health supplement does not satisfy the new standards, the business must align it within two years. Existing importer recommendations must be applied for again by 3 November 2028. The health supplement rule applies the same refiling requirement to an existing marketing-company recommendation used by the licence holder. Failure to reapply causes the recommendation to be revoked and declared invalid.
PerBPOM 20/2026 replaces the 2022 cosmetic notification procedure. A Product Information File must exist before notification, and the applicant must hold the required business licence and technical capability. One cosmetic name can be notified by only one applicant unless the applicants are qualifying related companies under common control and provide the prescribed notarial evidence.
The cosmetic rule creates a controlled route for one notification across several production facilities or contract producers. The products must have the same name, composition, raw-material specifications, packaging specifications, finished-product specifications, manufacturing process and labeling design. Every facility must hold the relevant good-manufacturing certificate, the contracts must contain the required information, the notification owner must maintain production records and the route is limited to no more than three contract manufacturers.
Cosmetic notifications are valid for up to three years and must be renewed before expiry if the product will continue to circulate. Existing notifications generally remain valid until expiry, but foreign contract cosmetic notifications must be aligned with the new requirements by 3 November 2027. New, changed and renewed notifications have followed PerBPOM 20/2026 since 3 November.
The enforcement range is material. The three registration rules allow electronic-access closure, application stoppage, activity suspension and authorization freeze, cancellation or revocation. The cosmetic rule adds warnings, temporary or permanent notification-access closure, an electronic import-certificate access block of up to one year and a ban on renewal. Companies should treat the package as a combined portfolio, contract, importer, principal, technical-file and post-market control project, not only as a new portal procedure.
Required action
- Inventory every quasi-drug, natural medicine, health supplement and cosmetic registration or notification, including pending applications, expiry dates, manufacturer, contract producer, importer, foreign principal, agency appointment, recommendation and responsible technical person.
- For quasi-drugs, natural medicines and health supplements, compare every existing product file against the new safety, efficacy or benefit, quality, formulation, labeling, good-manufacturing, import and applicant requirements and document any gap that must be closed within the two-year transition.
- Submit new applications and variations under PerBPOM 17-19/2026 using the correct domestic, contract, licence, export or import route, and keep each good-manufacturing certificate, importer recommendation and agency appointment valid for the full filing and market period.
- Reapply for existing importer recommendations within two years. Health supplement businesses that rely on a marketing-company recommendation as the licence holder must also submit a new recommendation application within that period.
- For cosmetics, confirm that the Product Information File exists before notification, that the notification applicant has the required business licence and technical person, and that every domestic, contract and import agreement is current, complete and notarized where required.
- Identify every foreign contract cosmetic notification and complete the PerBPOM 20/2026 alignment within 12 months. Where one notification covers multiple facilities or contract manufacturers, confirm identical name, composition, specifications, process and labeling and keep the contract-manufacturer count within the permitted maximum of three.
- Create launch and dormancy controls for quasi-drugs, natural medicines and health supplements so production or import starts within one year after authorization and does not stop for two consecutive years without a documented regulatory assessment.
- Place renewal dates, payment periods, clarification requests, labeling corrections, post-market monitoring, pharmacovigilance, retained-sample records, recalls and BPOM reporting under one accountable compliance calendar.