GREECE Law and Practice Contributed by: Angela Livgieri, Danai Panopoulou and Iliana Andronou, ALG Manousakis Law Firm
while in the second case, the applicant is the treating physician. Emergency and public health exceptions EOF can authorise a temporary supply of unap- proved medicines as follows. • According to paragraph 5 of Article 8 of Leg- islative Decree 96/1973, EOF may, in case of a public health emergency, proceed with the import of any pharmaceutical product with no limitations in terms of quantity and quality. • According to paragraph 6 of Article 8 of Legislative Decree 96/1973, EOF may permit importing unapproved medicinal products in limited quantities and for specific purposes. Medical Devices According to Article 59 of the MDR and as per Article 11 paragraph 13 of the Joint Ministerial Decision DY8d/130648/2009, any competent authority (EOF for Greece) may authorise the import of a specific device for which the proce- dures for placement in the market have not been carried out but the use of which is in the interest of public health or patient safety or health. 3.6 Marketing Authorisations for Pharmaceuticals and Medical Devices: Ongoing Obligations Pharmaceuticals MAH’s ongoing obligations are described in Arti- cle 36, 38, 39 and 40 of the JM Decision. Article 36 of the JM Decision provides that EOF may impose on MAH the obligation to conduct either: • a post-marketing safety study, if there are issues relating to the risks of a medicinal product; or
• a post-marketing efficacy study when the knowledge of the disease or the clinical methodology suggests that previous efficacy assessments may need a significant revision. Furthermore, according to Article 38 of the JM Decision, the MAH immediately informs EOF of any prohibition or restriction imposed by the competent authorities of any other country and any new information that might influence the pharmaceutical product’s risk-benefit balance. Article 39 of the JM Decision provides that the MAH notifies EOF of the exact date of the placement of the medicinal product in the Greek market. The MAH notifies EOF of any discon- tinuation (temporary or permanent) of commer- cialisation of the product at least three months before discontinuation. Article 12A of the Legislative Decree 96/1973 (Government Gazette A’ 172/3/8.8.1973) pro- vides that any MAH of medicinal products shall ensure the adequate and continuous supply of products to the market in order to meet the needs of patients in Greece. The electronic submission of individual case safety reports (ICSRs) in the Eudravigilance data- base is mandatory for MAHs either through the centralised procedure of Regulation 726/2004 or through the national procedure of Directive, as well as for clinical trial sponsors. Medical Devices Post-marketing vigilance. The competent authority in Greece, the EOF, has adopted the White Card system. Manufacturers are obliged to report to EOF all serious adverse events tak- ing place in Greece by submitting in English the following two types of reports:
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