Jakarta - The Ministry of Health (Kemenkes) held a socialization of Minister of Health Regulation (Permenkes) Number 17 of 2024, concerning the second amendment to Permenkes Number 14 of 2021. This regulation regulates the standards of business activities and products in the implementation of risk-based business licensing in the health sector.
The socialization, which took place in Jakarta on 18 December 2024, aimed to provide an understanding to all stakeholders and business actors in the health sector, and improve coordination, synergy, and identification of potential obstacles that could arise in the implementation of this new policy.
This activity was attended online by representatives from relevant ministries/institutions, technical implementation units within the Ministry of Health, as well as provincial, district and city health offices throughout Indonesia.
Permenkes No. 17 of 2024 comes as a strategic step to harmonize the standards of health sector business activities with the needs of the field.
The Head of the Legal Bureau of the Ministry of Health, Indah Febrianti, explained that this revision covers five business activity standards, namely Pharmacy Business Standards, Cosmetics Wholesalers, Traditional Medicine/Natural Medicine Wholesalers, Vector and Disease Carrier Control, and Clinics.
“This change aims to improve the ease of implementing business licensing and harmonize norms, standards, procedures, and criteria with the needs in the field,” Indah said.
In addition to simplifying licensing, this regulation also strengthens more structured supervision. The norms, standards, procedures, and criteria in this Permenkes become the sole reference for the central and regional governments in the health sector risk-based licensing process.
Indah also highlighted important changes in three standards in the pharmaceutical sector, namely the Pharmacy Business Standard, the Cosmetics Wholesaler Business Standard, and the Traditional Medicine/Natural Medicine Wholesaler Business Standard. These changes are expected to support operational efficiency and provide ease of licensing for business actors.
“This Permenkes is an important step in simplifying licensing in the health sector, so that it can have a positive impact on business actors and the community,” he added.
The Head of the Working Team for Pharmaceutical Services at the First Level Health Care Facility, Heru Sunaryo, outlined the changes in the pharmacy business standards. Among other changes are the addition of Commanditaire Venootschap (CV) as a non-individual business actor and adjustments to the means that pharmacies can stand alone or join first-level health service facilities (FKTP) and/or advanced levels (FKTL).
Meanwhile, Rengganis Pranandari, Chairperson of the Development and Monitoring Team for Natural Medicines, Cosmetics, Food, and Radio Farmaka Production Facilities, explained the changes to the Cosmetics Wholesaler Business Standard. Aspects of change include scope, definition, requirements, structure of HR and HR (technical person in charge), facilities, services, business management system, conformity assessment, and supervision.
“The scope of the PBK business, which originally only included cosmetics importers and cosmetics distributors, is now expanded to include cosmetics distributors with notification numbers, non-notification number distributors, and cosmetics importers,” said Rengganis. She also mentioned the addition of points in the general requirements, namely the exclusion of PBK business standard certificates for business actors who have a cosmetics industry license at the same business location.
In the service aspect, PBK can now distribute products through e-commerce on a wholesale basis. Meanwhile, in terms of conformity assessment and supervision, competencies that were originally only in the field of health supervision are now extended to the field of cosmetics regulation.
Rengganis also explained the changes to the Traditional Medicine/Natural Medicine (OT/OBA) Wholesaler Business Standard. This adjustment includes the expansion of the scope of business, which originally included the business of Traditional Medicine (OT) Wholesalers including health supplements for humans, to include the business of wholesale trading of OT/OBA, health supplements and quasi drugs. In addition, PB OT/OBA can distribute products through e-commerce on a wholesale basis by implementing distribution methods that comply with regulations.
In the aspect of general business requirements, there is an additional point, namely that the PB OBA business standard certificate is exempted for business actors who have business licenses for the OBA industry, OBA small businesses, and OBA micro businesses according to KBLI 21022, the OT / OBA Product industry for humans, in the same business location and distributing OBA, health supplements and quasi drugs of their own production.
Changes in the aspects of conformity assessment and supervision, namely originally the supervisor must have competence in the field of health supervision, was changed to the regulation of OBA, health supplements, and quasi drugs.
Rengganis added that the changes to PBK and PB OT/OBA regulations aim to simplify licensing, adjust to Law No. 17 of 2023 on health, and accommodate changes such as adjustments to the scope of business, human resources, and simplification of facilities.
With a more structured risk-based approach, the Ministry of Health is optimistic that the implementation of business licensing in the health sector will be more effective. This is expected to support the sustainability of health services, facilitate business actors, and ensure public protection.
This strategic step is expected to improve the quality of health services while strengthening regulations in the health sector according to national and global needs.