GREECE Law and Practice Contributed by: Angela Livgieri and Danai Panopoulou, ALG Manousakis Law Firm
In the first case, the applicant is the applicant for the marketing authorisation before the competent author- ity or the sponsor of the clinical trial, while in the sec- ond case, the applicant is the treating physician. Emergency and public health exceptions EOF can authorise a temporary supply of unapproved medicines as follows. • According to Article 8 (5) of Legislative Decree 96/1973, EOF may, in case of a public health emer- gency, proceed with the import of any pharmaceu- tical product with no limitations in terms of quantity and quality. • According to Article 8 (6) 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 Arti- cle 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 procedures 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 Ongoing Obligations Imposed by Marketing Authorisations Pharmaceuticals MAH’s ongoing obligations are described in Articles 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 knowl- edge 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 Deci- sion, the MAH immediately informs EOF of any prohi- bition or restriction imposed by the competent author- ities 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 the EOF of the exact date of the medicinal product’s placement in the Greek market. The MAH notifies EOF of any discontinuation (temporary or per- manent) of commercialisation of the product at least three months before discontinuation. Article 12A of the Legislative Decree 96/1973provides 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 database is mandatory for MAHs, whether through the centralised procedure under Regulation 726/2004 or the national procedure under the 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 taking place in Greece by submitting in English the following two types of reports: • the Manufacturers Incident Report (MIR) form; and • the Field Safety Corrective Action (FSCA) form. The following are reportable to EOF: (a) any malfunction or deterioration in the char- acteristics and/or performance of a product, as well as any deficiency in the labelling or instructions for use, which may cause or have caused the death or serious deterioration in the health of a patient; and (b) any technical or medical event relating to the characteristics or performance of a product which has led to the manufacturer’s systematic withdrawal from the market.
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