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{"id":1920,"date":"2024-02-15T01:16:16","date_gmt":"2024-02-15T01:16:16","guid":{"rendered":"https:\/\/selaraslawfirm.com\/?p=1920"},"modified":"2024-02-15T01:17:36","modified_gmt":"2024-02-15T01:17:36","slug":"pharmaceutical-industry-narcotics-distribution","status":"publish","type":"post","link":"https:\/\/selaraslawfirm.com\/pharmaceutical-industry-narcotics-distribution\/","title":{"rendered":"Pharmaceutical Industry: Narcotics Distribution"},"content":{"rendered":"\n\n\n

In accordance with Regulation of the Minister of Health Number 30 of 2023 on Narcotics, Psychotropics, and Pharmaceutical Precursors (\u201cRegulation of the MInister of Health 5\/2023\u201d), drug distribution is conducted by the pharmaceutical industry (\u201cPBF\u201d). 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.).<\/span><\/p>\n\n\n\n


According to the provisions of existing law,<\/span> Drugs or narcotics distribution is defined as <\/span>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. <\/span><\/p>\n\n\n\n

<\/a>Diving Deep: Narcotics Export & Import<\/span><\/strong><\/h2>\n\n\n\n
<\/div>\n\n\n\n

<\/a>Exports of Narcotics<\/span><\/strong><\/h3>\n\n\n\n

The exports of narcotics is divided between the exports of: <\/span>Pharmaceutical Precursors Production<\/span> (\u201cPharmaceutical Precursors EP\u201d),<\/span> Registered Psychotropics<\/span> (\u201cRegistered Psychotropics ET\u201d),<\/span> Registered Pharmaceutical Precursors<\/span> (\u201cRegistered Pharmaceutical Precursors ET\u201d).<\/span> For narcotics exporters to conduct their business, they;d need to fulfill the main requirements of having an Export Approval Letter (\u201cSPE\u201d) and the corresponding special export business permits.<\/span><\/p>\n\n\n\n

<\/a>Procedures to Conduct Narcotics Exportation<\/span><\/strong><\/h2>\n\n\n\n

According to the law, holders of the certificates mentioned above must firstly notify the relevant ministry 3 (three) days prior to the scheduled exportation (<\/span>pre-export notification<\/em><\/span> or \u201cPEN\u201d)<\/span>. The contents of said notification include: <\/span><\/p>\n\n\n\n

\n
\n
1.<\/span>Estimated date of Export; <\/span><\/div>\n<\/div>\n
\n
2.<\/span>Type of carrier (sea\/air) including its name and flight\/freight number; <\/span><\/div>\n<\/div>\n
\n
3.<\/span>Delivery details (name. seaport\/airport, importing country, and transits [if any]);<\/span><\/div>\n<\/div>\n
\n
4.<\/span>Estimated date of arrival in the Importing country.<\/span><\/div>\n<\/div>\n<\/div>\n\n\n\n
<\/div>\n\n\n\n

<\/a>Imports of Narcotics<\/span><\/strong><\/h3>\n\n\n\n

Just like narcotics exports, its importation requires several classifications as well. These are: <\/span>Psychotropics Production Importer<\/span> (\u201cPsychotropics IP\u201d), <\/span>Pharmaceutical Precursors Production Importer<\/span> (\u201cPharmaceutical Precursors Production IP\u201d), <\/span>Registered Psychotropics Importer<\/span> (\u201cRegistered Psychotropics IT\u201d), <\/span>Registered Pharmaceutical Precursors Importer<\/span> (\u201cRegistered Pharmaceutical Precursors IT\u201d). And just as well, narcotics importers require Import Approval Letter (\u201cSPI\u201d) and the corresponding special import business permits to be able to conduct their business.<\/span><\/p>\n\n\n\n

<\/a>Difference Between IT and IP<\/span><\/strong><\/h2>\n\n\n\n

The capacity that\u2019s 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.<\/span> On the other hand, IT certification <\/span>only<\/span><\/strong> 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.<\/span><\/p>\n\n\n\n

Note<\/span><\/strong>: The publication and authentication of SPI and SPE in Indonesia is done through its application via the Indonesian National Single Window integrated system.<\/span><\/p>\n\n\n\n

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\u2019s Pharmaceutical Industry. In which, they\u2019re allowed to conduct distribution towards other Pharmaceutical industries that hold mentioned special business permits.<\/span><\/p>\n\n\n\n

<\/a>Conclusion<\/span><\/strong><\/h2>\n\n\n\n

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 (<\/span>Pencegahan dan Pemberantasan Penyalahgunaan dan Peredaran Gelap Narkotika dan Prekursor Narkotika<\/em><\/span>)<\/span>. 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. <\/span><\/p>\n\n\n\n

<\/a>SELARAS COMPANY PROFILE<\/span><\/strong><\/a><\/h2>\n\n\n\n

Selaras is a Market Entry and Investment Consulting Firm. We provide strategic consulting for your investments and provide various services to companies, investors and individuals doing business in Indonesia. From remote hiring to setting up local operations, we can help.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

In accordance with Regulation of the Minister of Health Number 30 of 2023 on Narcotics, Psychotropics, and Pharmaceutical Precursors (\u201cRegulation of the MInister of Health 5\/2023\u201d), drug distribution is conducted by the pharmaceutical industry (\u201cPBF\u201d). The Pharmaceutical industry is further divided into Big Pharmaceutical Companies, Governmental Pharmaceutical Installation, Hospital Pharmaceutical Installation, Pharmaceutical Clinic Installation, and […]<\/p>\n","protected":false},"author":3,"featured_media":1921,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"_joinchat":[],"footnotes":""},"categories":[1],"tags":[],"_links":{"self":[{"href":"https:\/\/selaraslawfirm.com\/wp-json\/wp\/v2\/posts\/1920"}],"collection":[{"href":"https:\/\/selaraslawfirm.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/selaraslawfirm.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/selaraslawfirm.com\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/selaraslawfirm.com\/wp-json\/wp\/v2\/comments?post=1920"}],"version-history":[{"count":2,"href":"https:\/\/selaraslawfirm.com\/wp-json\/wp\/v2\/posts\/1920\/revisions"}],"predecessor-version":[{"id":1923,"href":"https:\/\/selaraslawfirm.com\/wp-json\/wp\/v2\/posts\/1920\/revisions\/1923"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/selaraslawfirm.com\/wp-json\/wp\/v2\/media\/1921"}],"wp:attachment":[{"href":"https:\/\/selaraslawfirm.com\/wp-json\/wp\/v2\/media?parent=1920"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/selaraslawfirm.com\/wp-json\/wp\/v2\/categories?post=1920"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/selaraslawfirm.com\/wp-json\/wp\/v2\/tags?post=1920"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}