GREECE Law and Practice Contributed by: Angela Livgieri and Danai Panopoulou, ALG Manousakis Law Firm
Emergency public health situations During pandemics, disasters, or shortages, pharma- ceutical products may be imported following a deci- sion of the EOF (Paragraph 5 of Article 8 of Legislative Decree 96/1973) Named patient programmes & compassionate use Importation of unapproved medicines for individual patients or for a group of patients following the EOF decision. For individual patients, the treating physician proposes (and EOF issues) an individual decision. 7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports In Greece, non-tariff regulations and restrictions on the importation of pharmaceuticals and medical devices are imposed based on their regulatory category and classification under the Combined Nomenclature (CN) Code, which is based on the Harmonised System (HS) Code. The Greek Customs Code (Law 2960/2001), in align- ment with the EU Customs Code (Regulation (EU) No 952/2013), provides that if the pharmaceutical product or the medical device meets the requirements of the applicable legislation for its manufacturing and pro- duction, it may be imported into Greece or any other European jurisdiction. Pharmaceuticals, governed by Directive, implemented in Greece through JM Decision, require authorisation from the EOF. Products must meet the provided qual- itative and quantitative composition standards, and batch testing may be required upon their termination. Medical devices are regulated under MDR and IVDR for in vitro diagnostic devices. All imported devic- es must bear the CE mark and be registered in the EUDAMED database. Customs authorities check for technical documentation, conformity assessments, and labelling compliance. Additionally, country-specific restrictions on products may be available in the EU TARIC database, which provides information on additional requirements, restrictions, or prohibitions.
Laws and Regulations governing these restrictions are outlined below. • Greek Customs Code (Law 2960/2001) – Estab- lishes the general import framework. • EU Customs Code (Regulation (EU) No 952/2013) – Sets import procedures across the EU. • Directive & JM Decision – Regulates pharmaceuti- cal 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 established 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 pharmaceuti- cal exports, eliminating tariffs entirely. Under the FTA with Canada (CETA), 99% of tariffs on pharmaceuti- cals have been abolished. The EU also has an FTA with Switzerland, where pharmaceutical trade ben- efits from tariff-free movement due to Switzerland’s participation in the EU Single Market. Once ratified, the pending EU-MERCOSUR trade agreement is expected to lead to tariff reductions on pharmaceuti- cal exports. As a member of the World Trade Organisation (WTO) since 1995, Greece adheres to global trade rules that promote transparency, fair market 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 market access by eliminating duplicate testing, expediting regulatory approvals, and accelerating entry into highly regulated markets.
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