GREECE Law and Practice Contributed by: Angela Livgieri, Danai Panopoulou and Iliana Andronou, ALG Manousakis Law Firm
7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices In Greece, the importation of pharmaceuticals and medical devices requires prior authorisa- tion from the National Organization for Medi- cines (EOF). Import licenses are necessary only for products brought in from non-EU countries. This is in accordance with the EOF Circular on the Import and Distribution of Pharmaceuticals (EG-18013-2013) and the regulation allowing the free movement of goods within the EU (DYG 3a 82161/12, Article 40). Importation of Pharmaceuticals According to the JM Decision (Government Gazette B’ 1049/29-04-2013), an importation license from EOF is required as follows. • Import Capability License: (a) company application with requested forms; (b) operating license from Authorities; (c) layout of required spaces; and (d) list of microbiological/chemical lab instru- ments (if self-testing). • Pharmaceutical Product Import License: (a) application specifying manufacturer, packaging, control site, origin, formula- tion, strength, and packaging; (b) Import Capability License for the request- ed form; (c) marketing authorisation; and (d) GMP Certificate issued by an EU/EEA Authority for the product or manufacturer. Importation of Medical Devices Distinction between based on CE mark: • CE-Marked Medical/In Vitro Diagnostic Devices (MDR/IVDR compliant); the importer must be registered with EOF; and
Key requirements: • Import Permit by EOF for controlled sub- stances (pharmaceuticals containing narcot- ics); • Wholesale Distribution Authorisation from EOF; • Marketing Authorisation or Parallel Import License; and • Customs Registration & VAT Compliance (AADE & Greek Customs Authority). Medical Devices According to guidance issued by EOF, import- ers of medical devices are required to notify their details to the National Electronic Registry of Medical Devices GREMDIS. Required docu- ments are: • CE Marking Certificate (for high-risk medi- cal devices) or certificate of the competent authority of the EU Member State where the products were registered (for low-risk Cat- egories); • manufacturer’s Declaration of Conformity; • outer packaging; • and • instructions for use. Key requirements: • registration with EOF as an importer; • CE Marking & Declaration of Conformity from the manufacturer • quality compliance certification (eg, ISO 13485); and • Customs and VAT Registration (AADE & Greek Customs Authority).
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