GREECE Law and Practice Contributed by: Angela Livgieri, Danai Panopoulou and Iliana Andronou, ALG Manousakis Law Firm
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 supply pharmaceuticals/devices to pharma- The Wholesale License is issued for a specific region and is valid for five years. If MAH or its local representative has a manufacturing license, no wholesale license is needed to distribute and 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 cies and hospitals. Pharmaceuticals • satisfy the remaining conditions of Presi- dential Decree 88/2004, “Organization 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 whole- saler fails to comply with regulatory obligations. Any certification which verifies compliance with
regulatory standards must be renewed every three years. 6.2 Different Classifications Applicable to Pharmaceuticals The classifications are described in the Direc- tive (Directive Title VI), national laws (3457/2006 & 3816/2010), and JM Decision (Article 95). According to Article 70 of the Directive and Arti- cle 95 of the abovementioned Decision, pharma- ceuticals are classified as: • a pharmaceutical subject to medical prescrip- tion; and • a pharmaceutical not subject to medical prescription. Based on the above, in Greece, the classification of pharmaceuticals is as follows: • Prescription-only medicines (POM) require a prescription from a licensed healthcare pro- fessional and are dispensed in pharmacies. Furthermore, according to Directive Article 70 paragraph 2, EOF has to classify further when labelling the following pharmaceuticals: (a) pharmaceuticals subject to a medical prescription; (b) pharmaceuticals subject to special medi- cal prescription; and (c) pharmaceuticals subject to “restricted” medical prescription reserved for use in hospitals. • Over-the-counter (OTC) medicines can be purchased without a prescription. Regulated under EOF guidelines and still subject to quality & safety controls.
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