GREECE Law and Practice Contributed by: Angela Livgieri, Danai Panopoulou and Iliana Andronou, ALG Manousakis Law Firm
• Greek Customs Code (Law 2960/2001) – Establishes the general import framework. • EU Customs Code (Regulation (EU) No 952/2013) – Sets import procedures across the EU. • Directive & JM Decision – Regulates pharma- ceutical imports. • MDR & IVDR – control medical device imports. 7.5 Trade Blocs and Free Trade Agreements Greece is a member of the European Union (EU), which operates as a trade bloc and has estab- lished multiple Free Trade Agreements (FTAs) and Mutual Recognition Agreements (MRAs) with third countries. The EU’s FTAs with Japan (EPA), South Korea, and the UK (TCA) provide duty-free access for pharmaceutical exports, eliminating tariffs entire- ly. In the case of the FTA with Canada (CETA), 99% of tariffs on pharmaceuticals have been abolished. The EU also has an FTA with Swit- zerland, where pharmaceutical trade benefits from tariff-free movement due to Switzerland’s participation in the EU Single Market. Once rati- fied, the pending EU-MERCOSUR trade agree- ment is expected to bring tariff reductions for pharmaceutical exports. As a member of the World Trade Organization (WTO) since 1995, Greece adheres to global trade rules that promote transparency, fair mar- ket access, and lower trade restrictions. Its participation in the WTO FTA reduces shipping times and administrative costs, which benefits pharmaceutical exports. Mutual Recognition Agreements (MRAs) with Canada, Switzerland and the UK facilitate mar- ket access by eliminating duplicate testing,
expediting regulatory approvals, and accelerat- ing entry into highly regulated markets.
8. Pharmaceutical and Medical Device Pricing and Reimbursement 8.1 Price Control for Pharmaceuticals and Medical Devices Pharmaceuticals According to Legislative Decree 96/1973 and Ministerial Decisions D3(a)/6295/2024 and D3(a) 59308/2024, the maximum prices for prescrip- tion-only medicinal products – specifically the retail price, wholesale price, hospital sale price, and ex-factory price – are determined using Price Bulletins issued by the Minister of Health. This process follows a proposal by the EOF, as stated in Article 17 of Legislative Decree 96/1973 (Government Gazette A’ 172/3/8.8.1973), and requires an application from the Marketing Authorization Holder (MAH). OTC medicinal products are excluded from this pricing struc- ture. Original medicinal products are priced in accord- ance with a median of the two lowest prices of the two Member States of the Eurozone. The same applies to off-patent medicinal products (original products following the expiration of their market exclusivity). Generic products are priced at 65% of the original product’s price, while bio- similars are priced using the same method as their originals (the two lowest prices in the Euro- zone). Non-prescribed pharmaceutical products (OTC) are priced in accordance with a median of three lowest prices of three EU Member States, and this price is indicative for pharmacies but mandatory for sales to hospitals. The final price of all the above categories of products is the ex- factory price on which the wholesale margin and the retail margin are added when the product is
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