GREECE Law and Practice Contributed by: Angela Livgieri and Danai Panopoulou, ALG Manousakis Law Firm
• Marketing Authorisation or Parallel Import License; and • Customs Registration & VAT Compliance (AADE & Greek Customs Authority). Medical Devices According to guidance issued by EOF, importers of medical devices are required to notify their details to the National Electronic Registry of Medical Devices GREMDIS. Required documents are: • CE Marking Certificate (for high-risk medical devices) or certificate of the competent authority of the EU Member State where the products were registered (for low-risk Categories); • 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). 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices In Greece, the importation of pharmaceuticals and medical devices requires prior authorisation from EOF. Import licenses are required only for products imported from non-EU countries. This is in accord- ance with the EOF Circular on the Import and Distri- bution 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 the authorities;
(c) layout of required spaces; and (d) list of microbiological/chemical lab instruments (if self-testing). • Pharmaceutical Product Import License: (a) application specifying manufacturer, packag- ing, control site, origin, formulation, strength, and packaging; (b) Import Capability License for the requested form; (c) marketing authorisation; and (d) GMP Certificate issued by an EU/EEA Author- ity for the product or manufacturer.
Importation of Medical Devices Distinction based on the CE mark:
• CE-Marked Medical/In Vitro Diagnostic Devices (MDR/IVDR compliant); the importer must be regis- tered with EOF; and • Non-CE-Marked Devices (not registered in Greece): EOF must provide specific import approval. Custom-made medical devices (eg, prosthetics) may be exempted from standard import requirements but must still be registered with EOF. In order to place their products on the Greek mar- ket, medical device importers are required to notify the National Electronic Registry of Medical Devices GREMDIS of their details. Required documents are: • CE Marking Certificate (for higher-risk medical devices) or Certificate of the competent authority of the EU Member State where the products were registered (for low-risk medical devices); • Manufacturer’s Declaration of Conformity;
• outer packaging; and • instructions for use. Exceptions Personal use
Patients can import small quantities of prescription medicines for personal use, but a doctor’s prescrip- tion and a patient declaration to customs are manda- tory.
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