In an emergency, the Central Government and Regional Governments can establish and implement special policies for the procurement and utilization of Pharmaceutical Supplies, Medical Devices, and other Health Supplies, one of which is the implementation of a special access scheme (SAS) mechanism for drug entry.

Drug importation through the Special Access Scheme (SAS) is the entry of drugs that do not yet have a distribution license but are urgently needed or have not been produced in Indonesia or have been produced but are not sufficiently available for health services.

In accordance with Government Regulation Number 5 of 2021 concerning the Implementation of Risk-Based Business Licensing, there is a division of authority in the issuance of SAS drug licenses. SAS drugs (except biological products) for health services, donations and government programs are approved by the Ministry of Health, which is further regulated in Minister of Health Regulation Number 14 of 2021 concerning Business Activity and Product Standards in the Implementation of Risk-Based Business Licensing in the Health Sector.

Meanwhile, SAS drugs for biological products, research and medicinal materials are approved by BPOM which is further regulated in the Food and Drug Supervisory Agency Regulation Number 30 of 2022 concerning the Entry of Drugs and Medicinal Materials through the Special Access Scheme.

Medicines imported into the territory of Indonesia through SAS must meet several criteria, namely meeting the standards and requirements for safety, efficacy, and quality in accordance with the provisions of laws and regulations; originating from official sources in accordance with the provisions of laws and regulations; not for regular use; in limited quantities in accordance with needs; and not for commercial purposes.

On June 26, 2024 in Jakarta, the Directorate General of Pharmaceuticals and Medical Devices of the Ministry of Health through the Directorate of Pharmaceutical Production and Distribution socialized the SiDiLaS Module (Special Access Scheme Service Digital System).

The SiDiLaS module is an application development for Drug Entry Permit Services through Special Lines, to accelerate SAS licensing services that accommodate starting from the application for recommendations from the National Drug Referral Center (PRON) Representative, application for SAS drug permits by Hospitals to monitoring the receipt of these drugs.

The socialization which was held in a hybrid manner was attended by representatives from the Secretariat General of the Ministry of Health, Directorate General of Health Services, Directorate of Communicable Disease Prevention and Control, Directorate General of Pharmaceuticals & Health Equipment, POM, National Drug Referral Center, DKI Jakarta Provincial Health Office, PMO Directorate General of Pharmaceuticals and Health Equipment, 50 Vertical Hospitals / Government / TNI / Police / Private and Pharmaceutical Industry in DKI Jakarta Province.

Director of Pharmaceutical Production and Distribution Dita Novianti Sugandi hopes that the SiDiLaS system can be implemented by hospitals and the pharmaceutical industry in submitting applications for drug entry permits through the Special Access Scheme and it is hoped that this socialization can provide a complete picture of the SiDiLaS system.