GREECE Law and Practice Contributed by: Angela Livgieri and Danai Panopoulou, ALG Manousakis Law Firm
has to classify further when labelling the following pharmaceuticals: (a) pharmaceuticals subject to a medical prescrip- tion; (b) pharmaceuticals subject to special medical prescription; and (c) pharmaceuticals subject to a “restricted” medi- cal prescription reserved for use in hospitals. • Over-the-counter (OTC) medicines can be pur- chased without a prescription. Regulated under EOF guidelines and still subject to quality and safety controls. 7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law and Relevant Enforcement Bodies Pharmaceuticals Directive 2001/83 (IV Section), along with the JM Deci- sion and EU Directive 2011/62 and the Joint Ministe- rial Decision D3 (α)41169/19/8-7-2020 (for the preven- tion of the entry into the legal supply chain of falsified medicinal products), set out the rules for the importa- tion and exportation of pharmaceuticals. Medical Devices MDR is the legal framework for importing and export- ing 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 mar- ket, the EOF has banned the export of certain medi- cines. 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) have introduced a mon- itoring 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): • controls import duties, VAT, and customs clear- ance; • works with the EOF to intercept counterfeit or ille- gal imports; and • 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 importing their own products); and • licensed wholesale distributors of medicines and medical devices. IFET (the national Greek public wholesaler) handles the import of medicines that are not commercially 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 that must include the specific medicines to be imported, the place of their production, the relevant premises, the technical equipment and the control capabilities for the importation process. Additionally, the applica- tion must designate at least one qualified individual responsible for these activities, as outlined in the aforementioned Ministerial Decision. Key requirements: • Import Permit by EOF for controlled substances (pharmaceuticals containing narcotics); • Wholesale Distribution Authorisation from EOF;
123 CHAMBERS.COM
Powered by FlippingBook