The Directorate General of Pharmaceuticals and Medical Devices of the Indonesian Ministry of Health through the Directorate of Pharmaceutical Production and Distribution held a socialization on the Implementation of Single Submission (SSm) for Narcotics, Psychotropic and Precursor (NPP) Pharmaceutical Licensing in the context of Strengthening Export and Import Controls of NPP Commodity Licensing in Jakarta on July 30, 2024.

This Single Submission-SSm for Narcotics, Psychotropic and Pharmaceutical Precursors (NPP) Licensing integrates 3 applications, namely INSW, e-BPOM (Analysis of Supervision Results-AHP) and e-pharm (Annual Needs Plan-RKT and Import Approval Letter-SPI), and involves three agencies namely the National Single Window (LNSW), POM, and the Ministry of Health.

The integration of these three systems is expected to accelerate the process of NPP commodity licensing services, so that the availability of NPP commodities in health services can be guaranteed.

Since July 29, 2024, NPP licensing services for the submission of Analysis of Monitoring Results (AHP) and Import Approval Letter (SPI) have been officially implemented in one door through the Single Submission (SSm) NPP Licensing system.

The meeting was attended by representatives from the LNSW of the Ministry of Finance, KPK, Badan POM, Ministry of Health, Institute of Sciences (LIP), Industry and Pharmaceutical Wholesalers.

In this meeting, a consultation desk was also held on the AHP and SPI submission process, which aims to provide guidance to business actors regarding AHP and SPI applications that are still in process in the old applications, namely NAPZA and e-PHARM. This consultation desk provides an opportunity for business actors to get a direct explanation of the steps that need to be taken in the transition to the new system.

Narcotics, psychotropic substances and pharmaceutical precursors (NPP) are commodities that are very important in health services, but on the other hand, they have great potential to be misused if there is no control and supervision because they can cause dependence. Therefore, the circulation of these three commodities must be closely monitored. Supervision is not only carried out by the government but also by the International Narcotics Control Board (INCB).

"The regulation of pharmaceutical NPP is not only in health care facilities, but from upstream to downstream, starting from the importation of raw materials, the production process at production facilities, distribution to distribution facilities and storage, distribution to service facilities to delivery or use in health care facilities," said Director of Pharmaceutical Production and Distribution Dita Novianti Sugandi in her speech.

According to Dita, the purpose of this regulation is to ensure the availability of pharmaceutical NPPs that meet quality, safety and efficacy requirements for the benefit of health services and/or the development of science and technology. In addition, what is no less important is to prevent leaks and deviations from legal channels to illegal channels or vice versa in order to protect and save the Indonesian people from the abuse of narcotics, psychotropic substances and pharmaceutical precursors.

He further explained that controlling the export and import of NPP commodities is the target of the Stranas PK action program for 2023-2024 with outputs: implementation of business processes in the framework of the SSm Licensing mechanism. Therefore, the Single Submission-SSm of NPP Licensing is made which integrates 3 applications.

"The Ministry of Health as the central government in charge of regulating the availability and circulation of NPP commodities has issued several regulations that serve as the basis for the implementation of production, distribution, export, import and use of NPP drugs in health care facilities. The latest regulation is the Minister of Health Regulation Number 5 of 2023 concerning Narcotics, Psychotropic Substances, and Pharmaceutical Precursors," explained Dita.

Dita hopes that this meeting can provide a complete picture of the NPP Licensing SSm system for the Pharmaceutical Industry, Science Institutions, and Pharmaceutical Wholesalers. With a clear understanding of the system, it is expected that all parties can collaborate better and ensure that all procedures run smoothly.