GREECE Law and Practice Contributed by: Angela Livgieri, Danai Panopoulou and Iliana Andronou, ALG Manousakis Law Firm
• if new pharmacovigilance data show an unac- ceptable risk-benefit ratio. Modification of a marketing authorisation is applicable if new data on safety or efficacy is discovered. Temporary suspension is applied in case of unre- solved safety issues. For medical devices, the CE marking certifica- tion can be: • revoked if the device is not placed on the market within three years from the issuance of the certificate; • suspended or withdrawn if there is an increase in adverse events and the risk level is high; and • modified if additional safety measures are needed. 3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices Obtaining an Authorisation Pharmaceuticals The regulatory process for national market- ing authorisation by EOF is outlined in detail in the JM Decision (Article 7 et seq), and it is fully aligned with the centralised process (marketing authorisation from EMA) provided for in the Reg- ulation (EC) No 726/2004. The application for a national marketing authorisation for a medicinal product intended for human use is submitted to EOF. Medical devices The manufacturer of medical devices is required to submit all relevant data to the EOF for the identification of these products before they are marketed (including the CE marking and the
instructions for use). This requirement is out- lined in Article 14 of Joint Ministerial Decision DY8d/130648/2009, Article 10a of Joint Ministeri- al Decision DY8d/130644/2009, and Article 10 of Joint Ministerial Decision DY8d/3607/892/2001. The rules regarding conformity assessment and CE marking of medical devices also depend on their classification as category I, category IIa, category IIb and category III medical devic- es, made-on-order medical devices or active implantable medical devices. In particular, every manufacturer of category I or on-order medical devices that sells in the Greek market under its name or via an authorised representative based in Greece (when the manufacturer’s registered office is outside the EU) is registered in the Reg- ister of Manufacturers of the EOF, to affix the CE marking on the medical devices (Article 14 of Joint Ministerial Decision DY8d/130648/2009). Every manufacturer of category IIa, IIb, and III medical devices, of active implantable medical devices, as well as of in vitro diagnostic medi- cal devices, submits a technical dossier of the products to a Notified Body within the EU, which assesses their compliance with the legal require- ments and issues a CE marking certificate (Arti- cle 16 and Annex XI of Joint Ministerial Decision DY8d/130648/2009, Article 9 and Annex II of Joint Ministerial Decision DY8d/130644/2009, as well as Article 9 and Annex II of Joint Minis- terial Decision DY8d/3607/892/2001). Variation of an Authorisation Pharmaceuticals According to Article 43 of the JM Decision, any changes to an existing marketing authorisation are determined by the EOF. An application pro- viding a specific form that follows the template set by the EMA must be submitted to the EOF to initiate a variation.
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