{"id":527,"date":"2026-08-31T18:16:03","date_gmt":"2026-08-31T16:16:03","guid":{"rendered":"https:\/\/www.pqra.gr\/greece-as-a-european-entry-point-what-launching-here-actually-involves\/"},"modified":"2026-08-31T18:16:10","modified_gmt":"2026-08-31T16:16:10","slug":"greece-as-a-european-entry-point-what-launching-here-actually-involves","status":"publish","type":"post","link":"https:\/\/www.pqra.gr\/el\/greece-as-a-european-entry-point-what-launching-here-actually-involves\/","title":{"rendered":"Greece as a European Entry Point: What Launching Here Actually Involves"},"content":{"rendered":"<p style=\"font-size:19px;line-height:1.7;color:#33414d;\"><strong>Greece is a full EU Member State with a mature regulatory authority, high pharmaceutical consumption and a price that travels well beyond its borders. It is also a market where a marketing authorisation buys you roughly half the journey \u2014 and where the median new medicine takes well over a year to reach a reimbursed patient.<\/strong><\/p>\n\n<h2>Who decides what<\/h2>\n\n<p>Four bodies matter, and they are frequently confused:<\/p>\n\n<ul>\n<li><strong>EOF<\/strong>, the National Organisation for Medicines, grants national, mutual recognition and decentralised marketing authorisations, runs pharmacovigilance, GMP and clinical trial oversight, and hosts the pricing department that prepares the price bulletins.<\/li>\n<li><strong>The Ministry of Health<\/strong> sets prices by ministerial decision, published as the price bulletin, on EOF&#8217;s proposal.<\/li>\n<li><strong>The Assessment and Reimbursement Committee<\/strong>, established by Law 4512\/2018 and seated at EOF, issues a non-binding opinion; the Minister decides.<\/li>\n<li><strong>The Negotiation Committee<\/strong>, seated at EOPYY but reporting to the Minister of Health, concludes managed entry agreements, confidential discounts and risk-sharing arrangements.<\/li>\n<li><strong>EOPYY<\/strong> is the payer. Reimbursement costs fall on its budget, and overspend feeds the clawback.<\/li>\n<\/ul>\n\n<h2>The sequence<\/h2>\n\n<p>A centrally authorised product still needs national steps. The company must obtain the nine-digit EOF code, which is what unlocks pricing. Before a product can be priced, the Assessment Committee must first classify it as potentially reimbursed or non-reimbursed. Pricing follows, then HTA assessment, then negotiation, then the ministerial listing decision, then EOPYY reimbursement.<\/p>\n\n<p>The published deadlines are:<\/p>\n\n<ul>\n<li>First pricing of reference products, biosimilars and hybrids: <strong>90 days<\/strong> from application; generics, 30 days. The clock restarts if the dossier is incomplete.<\/li>\n<li>New medicines are priced on a <strong>quarterly<\/strong> cycle, with a separate annual re-pricing bulletin issued by December each year.<\/li>\n<li>The ministerial decision on inclusion in the positive list carries a <strong>180-day exclusive deadline<\/strong> from filing. Biosimilars and vaccines get a summary assessment within one month.<\/li>\n<li>After a rejection, a new application may be filed after three months with new evidence.<\/li>\n<\/ul>\n\n<p>Published research on the Greek system found median times from regulatory approval to HTA application of around 420 days for new active substances, and from HTA application to reimbursement of around 228 days \u2014 so actual timelines materially exceed the statutory deadline, though the assessment backlog fell sharply between 2020 and 2023.<\/p>\n\n<h2>The filing gate most companies discover late<\/h2>\n\n<p>Under Law 4512\/2018 as amended, a patent-protected medicine is subject to HTA in Greece <strong>only if it is already reimbursed in at least five of eleven reference countries<\/strong>: Austria, Belgium, France, Germany, Denmark, Spain, the Netherlands, Italy, Portugal, Sweden and Finland. EFPIA identifies this requirement as a principal driver of Greece&#8217;s comparatively low filing rate.<\/p>\n\n<p>The practical consequence is that Greece cannot be a first launch for a patent-protected product. It has to be sequenced after enough of the eleven, which makes the order of your European filings a Greek access decision as much as a pricing one.<\/p>\n\n<h2>Why the Greek price matters everywhere else<\/h2>\n\n<p>Greece prices by external reference \u2014 the maximum ex-factory price is the average of the two lowest different prices among Eurozone Member States, requiring prior pricing in at least three (two for orphans), drawn from EURIPID and official national publications.<\/p>\n\n<p>More importantly, Greece is itself widely referenced. The European Commission&#8217;s 2013 study of external reference pricing found Greece in 13 of 31 European baskets \u2014 a figure that should always be dated, since baskets have changed since. Currently verifiable examples include Bulgaria, Romania, Cyprus, Austria, Slovakia and Hungary. The same study cited industry modelling that a 10% price drop in Greece in 2011 would have implied losses of \u20ac299 million in Greece and \u20ac799 million across Europe.<\/p>\n\n<p>That asymmetry is the whole argument for taking Greece seriously: the domestic revenue is modest, the international consequence of the number you accept is not. It is also the argument for using the confidential negotiated route where available \u2014 Greek listing decisions expressly contemplate a reimbursement price that may be confidential, agreed through negotiation.<\/p>\n\n<h2>What kind of market you are entering<\/h2>\n\n<p>Greek per-capita retail pharmaceutical spending was reported at EUR 586 in 2023 against an EU average of EUR 510 on a purchasing-power-adjusted basis, with retail pharmaceuticals at 27% of total health spending against an EU average of 13% \u2014 the second-highest share in the EU. Total pharmaceutical expenditure was estimated at around \u20ac8.5 billion in 2024.<\/p>\n\n<p>Set against that, the clawback and rebate framework now runs to 2030, and mandatory industry returns have reached a substantial share of total pharmaceutical expenditure. Any Greek business case has to be built on net, not list.<\/p>\n\n<h2>How PQRA helps<\/h2>\n\n<p>We handle the national steps a centralised authorisation still requires, secure the EOF code, prepare pricing applications and HTA dossiers for the Assessment Committee, support negotiation strategy including managed entry and confidential agreements, and model the clawback exposure before you commit to a price.<\/p>\n\n<p>Deciding whether and when to file in Greece? <a href=\"\/el\/contact\/\">Ask PQRA for a route-to-market assessment.<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Greece is a full EU Member State with a mature regulatory authority, high pharmaceutical consumption and a price that travels well beyond its borders. It is also a market where a marketing authorisation buys you roughly half the journey \u2014 and where the median new medicine takes well over a year to reach a reimbursed [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":528,"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-527","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>Greece as a European Entry Point: What Launching Here Actually Involves - 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\/greece-as-a-european-entry-point-what-launching-here-actually-involves\/\" \/>\n<meta property=\"og:locale\" content=\"el_GR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Greece as a European Entry Point: What Launching Here Actually Involves - PQRA\" \/>\n<meta property=\"og:description\" content=\"Greece is a full EU Member State with a mature regulatory authority, high pharmaceutical consumption and a price that travels well beyond its borders. 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