{"id":20386,"date":"2025-10-21T10:16:38","date_gmt":"2025-10-21T07:16:38","guid":{"rendered":"https:\/\/www.obi.gr\/?p=20386"},"modified":"2025-10-22T10:25:09","modified_gmt":"2025-10-22T07:25:09","slug":"ministerial-decision-73890-17-10-2025-government-gazette-b-5566-what-are-the-changes-to-the-supplementary-protection-certificate-spc-for-medicines","status":"publish","type":"post","link":"https:\/\/www.obi.gr\/en\/ministerial-decision-73890-17-10-2025-government-gazette-b-5566-what-are-the-changes-to-the-supplementary-protection-certificate-spc-for-medicines\/","title":{"rendered":"Ministerial Decision 73890\/17.10.2025 (Government Gazette B\u2019 5566) \u2013 What are the changes to the Supplementary Protection Certificate (SPC) for medicines"},"content":{"rendered":"<p>By Ministerial Decision No. 73890\/17.10.2025 (Government Gazette B\u2019 5566), titled <strong data-start=\"82\" data-end=\"264\">\u201cDetermination of the procedure for granting the Supplementary Protection Certificate for medicinal products \u2013 Repeal of Joint Ministerial Decision No. 14905\/EFA\/3058\/30.12.1997\u201d<\/strong>, which governs the procedure for granting Supplementary Protection Certificates for medicinal products, the process for granting SPCs is improved, among other things, through a more comprehensive examination of the conditions for granting such certificates.<\/p>\n<p data-start=\"533\" data-end=\"565\">Under this Ministerial Decision:<\/p>\n<ul>\n<li data-start=\"569\" data-end=\"711\">Joint Ministerial Decision No. 14905\/EFA\/3058\/30.12.1997\u2014which had regulated the SPC granting procedure until now\u2014is expressly repealed.<\/li>\n<li>Paragraph 1 of Article 7 of the repealed decision is amended so that, from now on, the Hellenic Industrial Property Organisation (OBI) shall conduct a full examination of all the conditions set out in Article 3 of Regulation (EC) No 469\/2009 of the European Parliament and of the Council, explicitly including points (c) and<strong> (d),<\/strong> which relate to the validity of the first marketing authorization and the absence of a previously issued certificate for the same product.<\/li>\n<\/ul>\n<p data-start=\"1211\" data-end=\"1536\">Furthermore, it is established that <strong data-start=\"1247\" data-end=\"1361\">applications for the granting of Supplementary Protection Certificates submitted from 1 September 2025 onwards<\/strong> <strong>shall be examined<\/strong> <strong data-start=\"1380\" data-end=\"1448\">exclusively under the provisions of the new Ministerial Decision<\/strong>, in accordance with the updated procedural and substantive requirements it lays down.<\/p>\n<p><a href=\"https:\/\/www.obi.gr\/wp-content\/uploads\/2025\/10\/\u0392-5566_\u03a5\u0391-73890_17.10.2025_\u03a3\u03a0\u03a0\u03a6.pdf\">\u0392 5566_Ministerial Decision 73890_17.10.2025_SPC for Medicines (Greek)<\/a><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>By Ministerial Decision No. 73890\/17.10.2025 (Government Gazette B\u2019 5566), titled \u201cDetermination of the procedure for granting the Supplementary Protection Certificate for medicinal products \u2013 Repeal of Joint Ministerial Decision No. 14905\/EFA\/3058\/30.12.1997\u201d, which governs the procedure for granting Supplementary Protection Certificates for medicinal products, the process for granting SPCs is improved, among other things, through a [&hellip;]<\/p>\n","protected":false},"author":22,"featured_media":20384,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[63,72],"tags":[],"class_list":{"0":"post-20386","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-important-en","8":"category-nea-en"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.6 - 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