GREECE Law and Practice Contributed by: Angela Livgieri and Danai Panopoulou, ALG Manousakis Law Firm
3.3 Period of Validity of Marketing Authorisations Validity and Renewal Pharmaceuticals
• revoked if the device is not placed on the market within three years from the issuance of the certifi- cate; • suspended or withdrawn if there is an increase in adverse events and the risk level is high; and • modified if additional safety measures are needed. 3.4 Procedure for Obtaining a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 Obtaining an Authorisation Pharmaceuticals The regulatory process for national marketing authori- sation by EOF is outlined in detail in the JM Deci- sion (Article 7 et seq.), and is fully aligned with the centralised process (marketing authorisation from EMA) provided for in Regulation (EC) No 726/2004. The application for a national marketing authorisation for a medicinal product intended for human use is submitted to the 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 (includ- ing the CE marking and the instructions for use). This requirement is outlined in Article 14 of Joint Ministe- rial Decision DY8d/130648/2009, Article 10a of Joint Ministerial 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 clas- sification as: • category I, category IIa, category IIb or category III 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 Register of Manufacturers of the EOF, to affix the CE marking on the medical devices (Article 14 of Joint Ministerial Decision DY8d/130648/2009). • made-on-order medical devices; or • active implantable medical devices.
Marketing authorisations are valid for five years from the date of approval. If a renewal is approved, the authorisation lasts indefinitely unless further safety monitoring is necessary, in which case the renewal is for an additional five-year period (Article 40 (4) and (5) of Joint Ministerial Decision DYG3a/32221/2013). Medical devices A CE certificate, necessary for the marketing of medi- cal devices, is issued by a notified body for a five- year term (as per Article 56, paragraph 2, of the MDR). Manufacturers must provide updated clinical evalua- tions, performance data and post-market surveillance reports to renew the CE certificate. The said CE cer- tificate is issued by a notified body (ie, the organisa- tion responsible for the CE certification issuance and conformity assessment procedures as per Article 1, paragraph 2ie), Article 11 and 16 of the Joint Min- isterial Decision DY8d/130648/2009 – their specific requirements are set out in Annex VII of the MDR, in Greece, Ministry of Health is responsible for their compliance as per Article 3 of the Ministerial Decision A4g/88159/2017. Revocation, Variation, Suspension or Withdrawal Revocation by EOF or EMA if according to Article 40 (4) of JM Decision: • the product is not placed on the market within three years of authorisation; • the product is not marketed for a continuous period of three years; or • if new pharmacovigilance data show an unaccep- table risk-benefit ratio. Modification of a marketing authorisation is applicable if new data on safety or efficacy is discovered. A temporary suspension is applied in cases of unre- solved safety issues. For medical devices, the CE marking certification can be:
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