Regulation Watch · Tourism and Health · Indonesia. The decision applies nationally to licensed hypermarkets, supermarkets and minimarkets that supply or hand over over-the-counter and limited over-the-counter medicines, including their distribution centres, branch distribution centres, partner pharmacies and drugstores.
Retail Medicine Sales Get New Licensing and Supervision Rules
Health Minister Decision HK.01.07/Menkes/1197/2026 replaces the retail framework for non-prescription medicines, requires qualifying distribution centres to obtain PBF and CDOB approvals by 16 October 2027, and makes certified staff, pharmaceutical supervision, controlled supply and recurring reporting mandatory for hypermarkets, supermarkets and minimarkets.
- Published
- The Minister of Health established Decision HK.01.07/Menkes/1197/2026 on 16 October 2026. The official Ministry of Health JDIH record identifies no separate promulgation date or State Bulletin publication for this ministerial decision. Regulation Watch first recorded it on 14 November 2026 after the official JDIH surfaced the replacement instrument and signed text.
- Effective
- 16 October 2026, the date of establishment stated in the decision. It immediately revoked Decision HK.01.07/Menkes/972/2025. The new one-year compliance periods for distribution-centre approvals and staff training expire on 16 October 2027.
- Added to Watch
- 14 November 2026
Who is affected
PT PMA and PT PMDN retail operators, foreign and Indonesian shareholders and directors, hypermarket, supermarket and minimarket owners and franchisees, retail distribution-centre operators, pharmacies, drugstores, pharmacists, health-support staff, procurement and supply-chain teams, and compliance teams responsible for non-prescription medicine sales.
Practical impact
A retail store may obtain covered medicines only through its licensed internal distribution centre, a pharmacy or a drugstore. A distribution centre used for this activity must hold a pharmaceutical wholesaler business licence through OSS and a Good Distribution Practice certificate, with branch licensing where applicable. A store without a distribution centre must have a written cooperation agreement with a pharmacy or drugstore, and one pharmacy or drugstore may supervise no more than five stores in the same regency or city. Every store must use trained health-support staff, operate under pharmaceutical supervision, maintain controlled ordering and stock records, limit supply to the smallest package and a maximum three-day quantity, check identification for customers aged at least 18 buying restricted medicines containing pharmaceutical precursors or dextromethorphan, and exclude products within three months of expiry.
Decision HK.01.07/Menkes/1197/2026 was established and took effect on 16 October 2026. It immediately revoked the 2025 decision on the same subject and aligns the retail framework with Health Minister Regulation 5/2026 on health supplies. The Ministry of Health JDIH lists the decision as in force and provides the signed 14-page text.
The replacement decision separates the supply route according to the retailer's operating model. A retailer with an internal distribution centre uses that centre and any properly licensed branches. A retailer without one obtains retail quantities through a pharmacy or drugstore under a written cooperation agreement. The 2026 decision expressly adds pharmacies to the permitted external route and specifies order, supervision, reporting and payment terms for the agreement.
An internal distribution centre must hold a pharmaceutical wholesaler licence selected as a supporting business activity in OSS and a CDOB certificate. The decision gives existing covered centres one year, until 16 October 2027, to obtain both approvals. Branch centres require their own branch PBF licence and are generally limited to the licensed province, with a documented notice route for an adjoining province.
A pharmacy or drugstore may supervise no more than five hypermarkets, supermarkets or minimarkets in the same regency or city. The retailer must submit signed requests, and the provider must obtain the medicines through an industry, PBF or PBF branch. The cooperation agreement must require pharmaceutical supervision and reporting at least once every three months. The pharmacy or drugstore must also report its supervised-store list annually and when requested.
Stores must hand covered medicines to customers through health-support staff. The owner must facilitate accredited training, and the staff member must hold the resulting certificate no later than 16 October 2027. The 2026 decision also requires the operation to remain under pharmaceutical supervision from the internal distribution centre, pharmacy or drugstore, depending on the supply route.
The supervising pharmaceutical professional must review every order for reasonableness, review receipts and issues at least once every three months, evaluate the store's medicine management at least once every three months and record the supervision. The resulting reports go to the Ministry of Health, relevant provincial and regency or city health offices and the relevant BPOM technical unit.
At the point of sale, medicines must remain in the smallest package with the original information and may cover no more than three days of use. Restricted medicines containing a pharmaceutical precursor or dextromethorphan may be supplied only to a person aged at least 18 after identity verification. Stores may not compound, repack, redistribute or supply damaged, unsafe or poor-quality medicine, and they must block medicine that is within three months of expiry.
The decision does not state a separate sanction table. Its duties are nevertheless inspection-ready controls under the wider health, BPOM and OSS licensing framework. Retail groups should therefore treat the October 2027 approvals and training as hard deadlines while applying the immediate supply, supervision, documentation and point-of-sale controls now.
Required action
- Identify every hypermarket, supermarket and minimarket that sells over-the-counter or limited over-the-counter medicine and document whether it uses an internal distribution centre, a pharmacy or a drugstore.
- For an internal distribution centre, apply through OSS for the supporting-activity PBF business licence and the CDOB certificate, verify any branch PBF licence, appoint the responsible pharmacist and complete the approval process by 16 October 2027.
- For a store without a distribution centre, sign or update a written agreement with a licensed pharmacy or drugstore covering supply, pharmaceutical supervision, quarterly reporting and payment. Confirm that the provider supervises no more than five stores in the same regency or city.
- Appoint health-support staff for each covered store and complete accredited training on management of over-the-counter and limited over-the-counter medicines. Retain the certificate and finish the process by 16 October 2027.
- Implement pharmaceutical supervision that reviews each order, reviews receipts and issues at least once every three months, evaluates medicine management at least once every three months and records reports to the relevant health authorities and BPOM unit.
- Revise point-of-sale controls to supply only the smallest package and no more than a three-day quantity, verify age and identity for restricted medicines containing pharmaceutical precursors or dextromethorphan, and prevent repacking, compounding, redistribution or sale of unsuitable stock.
- Create expiry controls that block covered medicines within three months of expiry and preserve purchase orders, receiving records, stock movements, staff certificates, supervision records, agreements and annual network lists for inspection.