In accordance with Regulation of the Minister of Health Number 30 of 2023 on Narcotics, Psychotropics, and Pharmaceutical Precursors (“Regulation of the MInister of Health 5/2023”), drug distribution is conducted by the pharmaceutical industry (“PBF”). The Pharmaceutical industry is further divided into Big Pharmaceutical Companies, Governmental Pharmaceutical Installation, Hospital Pharmaceutical Installation, Pharmaceutical Clinic Installation, and other smaller entities (such as: dispensary, medicinal stores, etc.).
According to the provisions of existing law, Drugs or narcotics distribution is defined as any narcotics delivery activities, in the context of trading, not trading, or transfer for the purposes of health service and development of science and technology. As it is, the act of narcotics distribution occurs between certain locations as well as between countries. These are called conveyance and narcotics transposition, accordingly. As such, these transits would require specific actors to take part, namely, exporters and importers.
Diving Deep: Narcotics Export & Import
Exports of Narcotics
The exports of narcotics is divided between the exports of: Pharmaceutical Precursors Production (“Pharmaceutical Precursors EP”), Registered Psychotropics (“Registered Psychotropics ET”), Registered Pharmaceutical Precursors (“Registered Pharmaceutical Precursors ET”). For narcotics exporters to conduct their business, they;d need to fulfill the main requirements of having an Export Approval Letter (“SPE”) and the corresponding special export business permits.
Procedures to Conduct Narcotics Exportation
According to the law, holders of the certificates mentioned above must firstly notify the relevant ministry 3 (three) days prior to the scheduled exportation (pre-export notification or “PEN”). The contents of said notification include:
Imports of Narcotics
Just like narcotics exports, its importation requires several classifications as well. These are: Psychotropics Production Importer (“Psychotropics IP”), Pharmaceutical Precursors Production Importer (“Pharmaceutical Precursors Production IP”), Registered Psychotropics Importer (“Registered Psychotropics IT”), Registered Pharmaceutical Precursors Importer (“Registered Pharmaceutical Precursors IT”). And just as well, narcotics importers require Import Approval Letter (“SPI”) and the corresponding special import business permits to be able to conduct their business.
Difference Between IT and IP
The capacity that’s available between Registered (IT) and Non-Registered (IP) differs in terms of its rights of production usage and commercialization. An IP type of importation allows the holder of such a certificate to conduct importation for the purpose of its own production and is prohibited to commercialize and.or transfer of narcotics. On the other hand, IT certification only allows its holder to import narcotics based on the order of scientific institutions that is directly being distributed towards such institutions. They are also prohibited to commercialize and/or transfer the narcotics mentioned.
Note: The publication and authentication of SPI and SPE in Indonesia is done through its application via the Indonesian National Single Window integrated system.
It is important to take note that in the case of Private Pharmaceutical Industry, the special business permits owned only applicable towards their own needs and capacity. This proves to be a different case when it comes to the Government’s Pharmaceutical Industry. In which, they’re allowed to conduct distribution towards other Pharmaceutical industries that hold mentioned special business permits.
Conclusion
This classification of narcotics imports and exports is crucial as it provides clear understanding on the roles that they take in their responsibilities to maintain the security of narcotics distribution and usage in Indonesia, as mandated in P4GN (Pencegahan dan Pemberantasan Penyalahgunaan dan Peredaran Gelap Narkotika dan Prekursor Narkotika). We at Selaras Law Firm (SLF) understand the importance of regulatory compliance and adaptability when it comes to such sensitive matters. Thus, we encourage you to contact us through our Contact Information below for consultation and/or legal services.
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