Regulation of the Minister of Health Number 5 of 2026 Restructures the Regulatory Framework for the Production, Distribution, and Supervision of Drugs, Medical Devices, Cosmetics, and Health Supplies

Introduction

On May 4, 2026, the Ministry of Health (“MOH”) issued Regulation of the Minister of Health Number 5 of 2026 on Health Supplies ("MOH Regulation 5/2026"). MOH Regulation 5/2026 regulates the planning, production, provision, circulation, control, guidance, and supervision of health supplies in Indonesia to ensure their availability, equitable distribution, and affordability for the public under various conditions.

In its considerations, the government states that MOH Regulation 5/2026 was formulated to implement several provisions in Government Regulation Number 28 of 2024 on Implementing Regulations of Law Number 17 of 2023 on Health, including Article 320 paragraph (5). Through MOH Regulation 5/2026, the government also regulates the standards for production, distribution, and supervision of health supplies to maintain supply and ensure that products circulating in the market comply with safety, efficacy, and quality requirements.

Comparison

MOH Regulation 5/2026 simplifies the regulation of health supplies by repealing and replacing 40 (forty) Minister of Health Regulations along with their annexes to eliminate overlapping regulations and standardize provisions in the health supplies sector.

Key Provisions

Business Licensing, Production Standards, Employment Qualifications, and Special Licenses

Article 13 and Article 15 require every health supply production facility to obtain a business license and implement GMP, which is evidenced by a certificate. Article 16 also requires every production facility to employ competent persons in charge, possess a GMP training certificate, and work full time. For the pharmaceutical industry, MOH Regulation 5/2026 requires the placement of at least 4 (four) different persons in charge for production, quality assurance, quality control, and distribution. Additionally, Article 20 requires facilities producing medicinal ingredients or narcotic drugs to possess a special narcotics production license.

Toll Manufacturing Production and Provisions for Micro and Small Enterprises

Article 18 allows production facilities to conduct manufacturing activities under licensing or contract manufacturing schemes (toll manufacturing) with other parties, provided that they meet GMP standards. Article 21 also provides ease of doing business for Micro and Small Enterprises (MSEs) to produce certain Medical Devices and Household Health Supplies (Perbekalan Kesehatan Rumah Tangga, “PKRT”). MSEs may conduct production using manual to semi-automatic equipment, do not generate hazardous and toxic waste (B3), and only produce low-risk goods that are not used for in vitro diagnostics.

Implementation of Plasma Fractionation

The domestic pharmaceutical industry may develop blood derivative products if it has been designated as a plasma fractionation facility and fulfills the GMP certificate as stipulated in Article 26. Such facilities may also send raw plasma materials abroad through a production contract set forth in a material transfer agreement. Furthermore, plasma fractionation facilities are permitted to import plasma if the supply from domestic blood management units is insufficient to meet needs, upon obtaining approval from the Minister of Health as stipulated in Article 28.

Research, Development, Incentives, and Clinical Trial Standards

The Central Government may provide fiscal and non-fiscal incentives to production facilities and researchers conducting research, development, and innovation as stipulated in Article 34. In conducting clinical trials involving human subjects, organizers are also required to implement Good Clinical Practice (“GCP”) and register clinical trials pursuant to Article 35. These provisions aim to protect research subjects and maintain the confidentiality and integrity of research data.

Obligations for Technology Transfer and Domestic Production of Imported Drugs

The production of international nonproprietary name generic drugs can only be carried out by pharmaceutical industries located domestically as stipulated in Article 25. Furthermore, Article 37 requires imported drugs to be produced domestically within a maximum of 5 (five) years or accompanied by gradual technology transfer through a roadmap prepared by the company.

Use of Local Materials in Phytopharmaceuticals and Procurement through Electronic Catalogues

Production facilities must prioritize domestic raw materials or production components as stipulated in Article 19. This obligation also applies to the natural medicine industry, where the phytopharmaceutical production process must prioritize local materials in accordance with Article 32. In the procurement of goods and services, government agencies and health service facilities are required to prioritize the use of health supplies with the highest Local Content value as stipulated in Article 41. Additionally, health supplies that use domestic raw materials and/or production components may be priced higher than imported products as stipulated in Article 41 paragraph (3), and are prioritized in procurement based on the Electronic Catalogue pursuant to Article 42.

Obligations for Buffer Stock, Production Capacity Reserves, and Grant Management

Production facilities, distributors, and pharmaceutical management facilities are required to calculate and provide a buffer stock of at least 10% (ten percent) and at most 30% (thirty percent) of the planned needs as stipulated in Article 40. Furthermore, health supply corporations are also required to reserve a portion of their production capacity to face certain conditions in accordance with Article 39. MOH Regulation 5/2026 also allows health supply industries and distributors to receive and manage health supply grants as stipulated in Article 48.

Exports, Imports of Used Medical Devices, and Special Access Scheme

The importation of health supplies must be processed through an electronic system integrated with the Indonesia National Single Window (“INSW”) system by attaching documents in the form of a Distribution License or Import Certificate as stipulated in Article 58. MOH Regulation 5/2026 also permits the import of non-new (used) medical devices for specific purposes after fulfilling safety test requirements pursuant to Article 58 paragraph (6). Under certain conditions, the importation of health supplies without a distribution license may be carried out through the Special Access Scheme (“SAS”) upon obtaining approval from the Minister of Health as stipulated in Article 62. Exemptions from the Minister of Health's approval are granted for the import of medical devices and household health supplies used for personal interests (including accompanied luggage or moving goods), temporary imports, re-importation of exported goods, and the needs of foreign state representations pursuant to Article 62 paragraph (6) and paragraph (8).

Distribution of Health Supplies, Retail Sales, and E-Commerce

The distribution and circulation of health supplies may only be carried out by manufacturers and distribution facilities that implement GDP as stipulated in Article 64. MOH Regulation 5/2026 also permits drug stores to distribute over-the-counter drugs and limited over-the-counter drugs to hypermarkets, supermarkets, and minimarkets in accordance with Article 76. Additionally, the handover of over-the-counter drugs, health supplements, cosmetics, and medical devices may be conducted through vending machines as stipulated in Article 74. Trade activities through electronic systems (e-commerce) are also permitted based on Article 79 and Article 80, subject to the obligation to report transaction data into the National Health Information System.

Integration of Electronic Prescriptions with the National Health Information System

Health service facilities are required to upload physical prescriptions into the integrated information system as stipulated in Article 78. MOH Regulation 5/2026 also requires health service facilities and telemedicine service providers to integrate electronic prescription services with electronic medical records within the National Health Information System. Furthermore, electronic prescriptions issued through telemedicine services may not be issued for drugs containing narcotics and psychotropics, as well as other preparations stipulated by the Minister pursuant to Article 78 paragraph (6).

Submission of Classification Changes

Businesses and research institutions may submit proposals for changes in the classification of Drugs, Natural Medicines, and Medical Devices to the Minister of Health as stipulated in Article 56. Such submissions must be accompanied by supporting documents in the form of study results on the safety and efficacy or usefulness of the related products.

Product Labeling, Halal Labels, and Advertisement Restrictions

Labeling on health supply packaging must objectively contain safety information as stipulated in Article 52. MOH Regulation 5/2026 also requires labeling to comply with the provisions of laws and regulations in the field of halal product assurance if the product uses ingredients that are not yet halal or are forbidden. Furthermore, Article 83 prohibits the advertisement of drugs whose usage requires a doctor's prescription, medical devices whose usage requires the assistance of medical personnel, and Processed Food for Special Medical Purposes (Pangan Olahan Keperluan Medis Khusus, “PKMK”) in general mass media. Advertisements for such products may only be broadcast through scientific media aimed at medical personnel.

Potential Supply Shortage Reporting System (Early Warning)

Distribution license holders are required to continuously produce or import health supplies and submit realization reports electronically as stipulated in Article 96. In addition, companies are also required to submit reports on potential health supply shortages to the Minister of Health no later than 6 (six) months before the potential scarcity is estimated to occur as part of the early warning system.

Post-Market Surveillance, Recall, Vigilance, and Inspection

Companies are required to conduct product recalls and product destruction if the health supplies no longer meet standards, have expired, or their distribution licenses have been revoked, as stipulated in Article 85 and Article 90. Furthermore, distribution license holders are also required to implement Pharmacovigilance programs for pharmaceutical preparations and Vigilance for medical devices and household health supplies pursuant to Article 104. These programs are conducted to detect and report adverse effects or incidents related to product usage. During inspection activities, production facilities, distribution facilities, and health service facilities are also required to provide access to premises, equipment, data, and information to the authorized officials as stipulated in Article 102 paragraph (6).

Reporting of Prices, Discounts, and Prohibition of Gratification

Manufacturers, distributors, and health service facilities are required to submit product price information to the government database as stipulated in Article 108. Such provisions also require companies to report discounts and incentives granted to medical personnel and professional organizations. Furthermore, the pharmaceutical industry is required to state the Highest Retail Price Limit on the labeling or packaging of drugs pursuant to Article 110. MOH Regulation 5/2026 also prohibits production facilities, distribution facilities, and health service facilities from engaging in gratification during the circulation of health supplies as stipulated in Article 82.

Transitional Provisions

The government provides a transition period of a maximum of 1 (one) year since MOH Regulation 5/2026 was promulgated as stipulated in Article 122, so businesses have until May 4, 2027, to adjust their business activities to the new provisions. However, provisions on import approvals for certain pharmaceutical preparations, such as narcotics, psychotropics, pharmaceutical precursors, and plasma as raw materials, must be adjusted within a maximum of 90 (ninety) days since MOH Regulation 5/2026 was promulgated pursuant to Article 123.

If businesses fail to comply with the provisions in MOH Regulation 5/2026, the Central Government may impose administrative sanctions as stipulated in Article 117 and Article 118. Such sanctions may include written warnings, administrative fines, temporary suspension of activities, product recall and destruction, blocking of electronic systems, blacklisting, and the suspension or revocation of business licenses.

Closing

MOH Regulation 5/2026 restructures the governance of the production, distribution, and supervision of health supplies in Indonesia by repealing and replacing 40 (forty) previous Minister of Health Regulations. MOH Regulation 5/2026 tightens the obligations for business licensing, implementation of GMP and GDP, placement of full-time persons in charge, and special licenses for the production of medicinal ingredients and narcotic drugs. On the other hand, MOH Regulation 5/2026 also permits production through licensing or contract schemes (toll manufacturing), provides ease of doing business for Micro and Small Enterprises to produce certain medical devices and household health supplies, and regulates the implementation of plasma fractionation, research and clinical trials, provision of research incentives, and submission of product classification changes. The Central Government also requires the use of domestic raw materials and components, including in the production of phytopharmaceuticals, and promotes the use of products with the highest Local Content value in government procurement and Electronic Catalogues. In the supply chain aspect, production facilities, distributors, and pharmaceutical management facilities are required to provide buffer stocks and reserve a portion of production capacity, while import activities must be processed through a system integrated with the Indonesia National Single Window, including provisions on the import of non-new (used) medical devices and the Special Access Scheme (SAS). MOH Regulation 5/2026 also regulates the distribution and trade of health supplies through drug stores, vending machines, and electronic commerce (e-commerce) integrated with the National Health Information System, including the integration of electronic prescription services and electronic medical records in health and telemedicine services. Furthermore, MOH Regulation 5/2026 requires product labeling to contain safety information and comply with halal product assurance provisions, restricts the advertisement of certain products, requires the reporting of potential supply shortages as part of the early warning system, implementation of Pharmacovigilance and Vigilance, and the provision of data and information access during inspection activities. Manufacturers, distributors, and health service facilities are also required to report prices, discounts, and incentives to the Central Government, while the pharmaceutical industry is required to state the Highest Retail Price Limit on drug packaging and is prohibited from engaging in gratification during the circulation of health supplies. To adjust to all of these provisions, the Central Government provides a transition period of a maximum of 1 (one) year since MOH Regulation 5/2026 was promulgated and 90 (ninety) days for provisions regarding the import of certain pharmaceutical preparations, under the threat of administrative sanctions in the form of written warnings, administrative fines, temporary suspension of activities, product recall and destruction, blocking of electronic systems, blacklisting, and the revocation of business licenses.