{"id":517,"date":"2023-10-20T10:31:32","date_gmt":"2023-10-20T10:31:32","guid":{"rendered":"https:\/\/companyincorporationmalta.com\/?p=517"},"modified":"2023-10-20T10:31:33","modified_gmt":"2023-10-20T10:31:33","slug":"set-up-a-pharmaceutical-company-in-malta","status":"publish","type":"post","link":"https:\/\/companyincorporationmalta.com\/set-up-a-pharmaceutical-company-in-malta\/","title":{"rendered":"Set Up a Pharmaceutical Company in Malta"},"content":{"rendered":"\n<p><strong>Pharmaceutical companies fall under the regulations of the Maltese Medicines Act of 2003<\/strong>\u00a0and\u00a0<strong>pharmacy licenses are issued according to the Subsidiary Legislation 458.16<\/strong>. In order to\u00a0<strong>open a pharmacy in Malta<\/strong>, the premises must first undergo an inspection from the Inspectorate and Enforcement Directorate of the Medicines Authority. A\u00a0<a href=\"https:\/\/www.companyincorporationmalta.com\/why-is-malta-an-attractive-country-for-investors\"><strong>Maltese company<\/strong><\/a><strong>\u00a0selling pharmaceutical products\u00a0<\/strong>is subject to five types of inspections:<\/p>\n\n\n\n<ul>\n<li>&#8211; for new applications,<\/li>\n\n\n\n<li>&#8211; for follow-up,<\/li>\n\n\n\n<li>&#8211; for renewal,<\/li>\n\n\n\n<li>&#8211; for variation,<\/li>\n\n\n\n<li>&#8211; spot check inspections.<\/li>\n<\/ul>\n\n\n\n<p>Also, in order to&nbsp;<strong>manufacture pharmaceutical products,<\/strong>&nbsp;the correct NACE code from the Nomenclature of Economic Activities must be selected:<\/p>\n\n\n\n<ul>\n<li>&#8211; DG 24.4 for manufacturing pharmaceuticals, medicinal chemicals and botanical products,<\/li>\n\n\n\n<li>&#8211; DG 24.41 for manufacturing basic pharmaceutical products,<\/li>\n\n\n\n<li>&#8211; DG 24.42 for manufacturing pharmaceutical preparations.<\/li>\n<\/ul>\n\n\n\n<p>For the&nbsp;<strong>retail of pharmaceutical products, a&nbsp;<\/strong><a href=\"https:\/\/www.companyincorporationmalta.com\/establish-subsidiary-malta\"><strong>Maltese company<\/strong><\/a>&nbsp;must select the G 52.3 for the retail of pharmaceutical and medical goods, cosmetic and toilet articles in the Nomenclature.<\/p>\n\n\n\n<p>Our&nbsp;<a href=\"https:\/\/www.companyincorporationmalta.com\/about-us\"><strong>Maltese agents in company formation<\/strong><\/a>&nbsp;will guide you through the registration procedure.<\/p>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_65 counter-hierarchy ez-toc-counter ez-toc-custom ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title \" >Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #002e5b;color:#002e5b\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #002e5b;color:#002e5b\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/companyincorporationmalta.com\/set-up-a-pharmaceutical-company-in-malta\/#what-are-the-licensed-pharmaceutical-activities-in-malta\" title=\"What are the licensed pharmaceutical activities in Malta?\">What are the licensed pharmaceutical activities in Malta?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/companyincorporationmalta.com\/set-up-a-pharmaceutical-company-in-malta\/#what-are-the-documents-to-be-submitted-when-applying-for-a-pharmacy-license-in-malta\" title=\"What are the documents to be submitted when applying for a pharmacy license in Malta?\">What are the documents to be submitted when applying for a pharmacy license in Malta?<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"what-are-the-licensed-pharmaceutical-activities-in-malta\"><\/span><strong>What are the licensed pharmaceutical activities in Malta?<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><a href=\"https:\/\/www.companyincorporationmalta.com\/open-a-maltese-limited-liability-company\"><strong>Pharmaceutical companies in Malta<\/strong><\/a>&nbsp;may apply for various licenses depending on the activities they will carry out. The following certificates may be issued for a&nbsp;<strong>Maltese pharmaceutical company<\/strong>:<\/p>\n\n\n\n<ul>\n<li>&#8211; a good manufacturing practice certificate,<\/li>\n\n\n\n<li>&#8211; a manufacturing license,<\/li>\n\n\n\n<li>&#8211; a wholesalers license,<\/li>\n\n\n\n<li>&#8211; a registered active pharmaceutical ingredients (API) importer and wholesale distributor license.<\/li>\n<\/ul>\n\n\n\n<p><strong>Maltese pharmacies<\/strong>&nbsp;may also act as registered brokers of medical products for human use.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"what-are-the-documents-to-be-submitted-when-applying-for-a-pharmacy-license-in-malta\"><\/span><strong>What are the documents to be submitted when applying for a pharmacy license in Malta?<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><a href=\"https:\/\/www.companyincorporationmalta.com\/register-company-malta\"><strong>Pharmaceutical companies in Malta<\/strong><\/a>&nbsp;are required to submit the following documentation when filing for a pharmacy license:<\/p>\n\n\n\n<ul>\n<li>&#8211; a prescribed application form,<\/li>\n\n\n\n<li>&#8211; a declaration of the managing pharmacist,<\/li>\n\n\n\n<li>&#8211; a clean criminal record issued by the police for the pharmacist license holder,<\/li>\n\n\n\n<li>&#8211; a plan of the premises with the total surface area endorsed by the declaration of an architect,<\/li>\n\n\n\n<li>&#8211; a detailed description of the pharmacy premises.<\/li>\n<\/ul>\n\n\n\n<p><a href=\"https:\/\/www.companyincorporationmalta.com\/types-of-companies-malta\"><strong>Maltese companies<\/strong><\/a><strong>&nbsp;opening pharmacies<\/strong>&nbsp;are also required to submit the articles of association of the company issued by the Malta Financial Services Authority.<\/p>\n\n\n\n<p>For complete information about&nbsp;<strong>pharmaceutical licensing requirements<\/strong>, please&nbsp;<a href=\"https:\/\/www.companyincorporationmalta.com\/contact-us\"><strong>contact<\/strong><\/a>&nbsp;our&nbsp;<strong>company incorporation agents in Malta.<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Pharmaceutical companies fall under the regulations of the Maltese Medicines Act of 2003\u00a0and\u00a0pharmacy licenses are issued according to the Subsidiary Legislation 458.16. In order to\u00a0open a pharmacy in Malta, the premises must first undergo an inspection from the Inspectorate and Enforcement Directorate of the Medicines Authority. A\u00a0Maltese company\u00a0selling pharmaceutical products\u00a0is subject to five types of [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":348,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[217,216,214,213,215],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Set Up a Pharmaceutical Company in Malta<\/title>\n<meta name=\"description\" content=\"Find here the requirements for opening a Maltese pharmaceutical company. For details about business licensing requirements please contact our agents in Malta.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/companyincorporationmalta.com\/set-up-a-pharmaceutical-company-in-malta\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Set Up a Pharmaceutical Company in Malta\" \/>\n<meta property=\"og:description\" content=\"Find here the requirements for opening a Maltese pharmaceutical company. 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