GREECE Law and Practice Contributed by: Angela Livgieri, Danai Panopoulou and Iliana Andronou, ALG Manousakis Law Firm
7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law for the Import and Export of Pharmaceuticals and Medical Devices and Relevant Enforcement Bodies Pharmaceuticals Directive 2001/83 (IV Section) along with the JM Decision and EU Directive 2011/62 along with Joint Ministerial Decision D3(α)41169/19/8-7- 2020 (for the prevention of the entry into the legal supply chain of falsified medicinal products) set out the rules for importation and exportation of MDR is the legal framework for importing and exporting medical devices, while IVDR is the legal framework for in vitro diagnostic medical devices. Competent Bodies • EOF is the competent authority. • To ensure an adequate supply of products in the market, the EOF has banned the export of certain medicines. Additionally, through Circular No 66718/2011, the EOF requires wholesalers to submit monthly intra-EU export data. In line with this, the Greek Customs Code (Law 2960/2001) and the EU Customs Code (Regulation (EU) No 952/2013) pharmaceuticals. Medical Devices have introduced a monitoring system, as outlined in Circular No 24151/2012, to track the domestic distribution of pharmaceuticals at the customer level for all wholesalers. • In response to COVID-19 supply chain challenges, EOF, in coordination with EMA, imposed temporary bans on parallel exports and intra-EU distribution.
• Greek Customs Authority (Independent Authority for Public Revenue – AADE): (a) controls import duties, VAT, and customs clearance; (b) works with EOF to intercept counterfeit or illegal imports; and (c) ensures compliance with tariff codes and EU single market rules. 7.2 Importer of Record of Pharmaceuticals and Medical Devices In Greece, an importer can be: • a MAH; • manufacturers with import licenses (if import- ing their own products); and • licensed wholesale distributors of medicines and medical devices. IFET (the national Greek public wholesaler) han- dles the import of medicines that are not com- mercially available in Greece and require special approval for pharmacies and hospitals Pharmaceuticals According to the JM Decision (Government Gazette B’ 1049/29-04-2013), which aligns Greek law with the Directive, an importation licence from EOF is required. Obtaining the licence requires filing an application, which must include the specific medicines to be imported, the place of their production, the relevant prem- ises, technical equipment, and control capabili- ties for the importation process. Additionally, the application must designate at least one qualified individual responsible for these activities, as out- lined in the aforementioned Ministerial Decision.
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