{"id":648,"date":"2026-09-20T18:17:29","date_gmt":"2026-09-20T16:17:29","guid":{"rendered":"https:\/\/www.pqra.gr\/authorising-a-veterinary-medicine-in-greece-routes-authority-and-local-practicalities\/"},"modified":"2026-09-20T18:17:34","modified_gmt":"2026-09-20T16:17:34","slug":"authorising-a-veterinary-medicine-in-greece-routes-authority-and-local-practicalities","status":"publish","type":"post","link":"https:\/\/www.pqra.gr\/el\/authorising-a-veterinary-medicine-in-greece-routes-authority-and-local-practicalities\/","title":{"rendered":"Authorising a Veterinary Medicine in Greece: Routes, Authority and Local Practicalities"},"content":{"rendered":"<p style=\"font-size:19px;line-height:1.7;color:#33414d;\"><strong>Companies bringing a veterinary product into Greece often assume the process mirrors the human medicines pathway they already know. Much of it does. The National Organisation for Medicines, EOF, is the national authority for veterinary as well as human medicinal products, and the EU-level procedures under Regulation (EU) 2019\/6 apply as they do everywhere. But the operational detail differs enough to cost time if it is discovered late.<\/strong><\/p>\n\n<h2>Who regulates what<\/h2>\n<p>EOF was established in 1983 under Law 1316 as a public law legal entity, with a mission that covers pharmaceutical products for both human and veterinary use. It is the authority responsible for evaluating applications for marketing authorisation and for granting or refusing them, and it regulates and supervises research, manufacturing, marketing and general handling of these products. Residues of veterinary medicines in food sit with the Ministry of Rural Development and Food, and authorisation for the retail sale of veterinary medicinal products follows its own national route.<\/p>\n<p>That division is the first thing to map. A question about a product authorisation, a question about residue controls in food of animal origin, and a question about who may retail the product go to different places.<\/p>\n\n<h2>The authorisation routes<\/h2>\n<ul>\n<li><strong>Centralised.<\/strong> Assessed by the European Medicines Agency with a Commission decision, giving a single authorisation valid across the Union. Mandatory for certain product categories and optional for others.<\/li>\n<li><strong>Decentralised.<\/strong> For products not yet authorised anywhere, submitted simultaneously to Greece and other chosen Member States with one acting as reference.<\/li>\n<li><strong>Mutual recognition.<\/strong> For products already authorised in another Member State, extended to Greece on the basis of that existing assessment.<\/li>\n<li><strong>National.<\/strong> For products intended for the Greek market alone.<\/li>\n<\/ul>\n<p>The choice is a commercial decision as much as a regulatory one. It should follow from where the product will actually be sold over its lifecycle, not from which route looks quickest for the first market.<\/p>\n\n<h2>What tends to cause delay locally<\/h2>\n<ul>\n<li><strong>Greek product information.<\/strong> Translation of the summary of product characteristics, labelling and package leaflet needs to be accurate and consistent with the approved text. Rushed translation creates avoidable rounds of questions.<\/li>\n<li><strong>Local representation.<\/strong> Arrangements for the local presence, contact points and responsibilities should be settled before submission, not during it.<\/li>\n<li><strong>Documentation completeness.<\/strong> Validation failures on administrative documents are common and entirely preventable.<\/li>\n<li><strong>Portfolio inconsistency.<\/strong> Where a company already holds Greek authorisations, new applications are read against the existing portfolio. Legacy inconsistencies surface at the worst moment.<\/li>\n<\/ul>\n\n<h2>After authorisation<\/h2>\n<p>Authorisation is the start of the obligations, not the end. Union Product Database records, variation management, pharmacovigilance, distribution oversight and, for antimicrobials, the stewardship framework all continue for the life of the product.<\/p>\n\n<h2>How PQRA helps<\/h2>\n<p>PQRA is based in Athens and works with EOF routinely. We advise on route selection, prepare and submit veterinary marketing authorisation applications, manage Greek product information, handle post-authorisation lifecycle work, and act as the local regulatory function for companies without a Greek presence.<\/p>\n\n<p>To discuss bringing a veterinary product to the Greek market, <a href=\"\/el\/contact\/\">contact PQRA<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"<p>Companies bringing a veterinary product into Greece often assume the process mirrors the human medicines pathway they already know. Much of it does. The National Organisation for Medicines, EOF, is the national authority for veterinary as well as human medicinal products, and the EU-level procedures under Regulation (EU) 2019\/6 apply as they do everywhere. But [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":649,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"saved_in_kubio":false,"_swpsp_post_exclude":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-648","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Authorising a Veterinary Medicine in Greece: Routes, Authority and Local Practicalities - PQRA<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.pqra.gr\/el\/authorising-a-veterinary-medicine-in-greece-routes-authority-and-local-practicalities\/\" \/>\n<meta property=\"og:locale\" content=\"el_GR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Authorising a Veterinary Medicine in Greece: Routes, Authority and Local Practicalities - PQRA\" \/>\n<meta property=\"og:description\" content=\"Companies bringing a veterinary product into Greece often assume the process mirrors the human medicines pathway they already know. 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