GREECE Law and Practice Contributed by: Angela Livgieri and Danai Panopoulou, ALG Manousakis Law Firm
• written records of manufacture and distribution with which the history of the batch can be traced. Upon approval of the application, EOF grants the manufacturing authorisation for the medical device in accordance with Article 2 of the Joint Ministerial Deci- sion DY8d/130648/2009. Manufacturing licenses for pharmaceuticals and med- ical devices typically remain valid indefinitely, provided that the manufacturer complies with ongoing regula- tory requirements. These include: • adherence to GMP rules and issuance of a relevant GMP certificate of compliance, which is valid for three years unless specific circumstances reduce or increase this period; and • adherence to relevant quality management stand- ards (eg, ISO 13485 for medical devices that must be renewed every three years). 6. Distribution of Pharmaceuticals and Medical Devices 6.1 Wholesale of Pharmaceuticals and Medical Devices Wholesalers must obtain a wholesale license issued by EOF. Application to EOF includes: • company details; • warehouse location; • description of storage and handling facilities; • list of medicinal products to be handled; and • responsible person certificate. Upon evaluation and on-site inspection to verify GDP standards, EOF grants a wholesale license, which gives the right to procure, store, distribute and sup- ply pharmaceuticals/devices to pharmacies and hos- pitals. Pharmaceuticals The Wholesale License is issued for a specific region and is valid for five years. If a MAH or its local repre- sentative holds a manufacturing license, no wholesale license is required to distribute or sell products.
The conditions for granting a wholesale license are outlined in Article 105 of the JM Decision and the Presidential Decrees 194/1995 and 88/2004. According to Article 105 of JM Decision, the applicant must: • have appropriate and sufficient premises and equipment; • employ staff, including a qualified person (QP) who meets the requirements set forth in the applicable legislation; • fulfil the obligations outlined in Article 106 of JM Decision; and • satisfy the remaining conditions of Presi- dential Decree 88/2004, “Organisation and Operating Specifications of a Pharmaceutical Warehouse.”Medical Devices For medical devices, the validity period is not explicitly set under MDR/IVDR, but compliance with regulations is continuously monitored, and EOF may revoke the authorisation if the wholesaler fails to comply with regulatory obligations. Any certification which veri- fies compliance with regulatory standards must be renewed every three years. 6.2 Different Classifications Applicable to Pharmaceuticals The classifications are described in the Directive (Direc- tive Title VI), national laws (3457/2006 & 3816/2010), and JM Decision (Article 95). According to Article 70 of the Directive and Article 95 of the abovementioned Decision, pharmaceuticals are classified as: • a pharmaceutical subject to medical prescription; and • a pharmaceutical not subject to medical prescrip- tion. Based on the above, in Greece, the classification of pharmaceuticals is as follows. • Prescription-only medicines (POM) require a pre- scription from a licensed healthcare professional and are dispensed in pharmacies. Furthermore, according to Directive Article 70 paragraph 2, EOF
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