GREECE Law and Practice Contributed by: Angela Livgieri, Danai Panopoulou and Iliana Andronou, ALG Manousakis Law Firm
2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial Pharmaceuticals Clinical trials are subject to scientific and ethical evaluation and are approved in accordance with Article 8 of the CTR. The EOF conducts a sci- entific evaluation of the clinical trial. If EOF has been granted the status of ‘reporting’ member state, it notifies the sponsor and other member states concerned via the EU portal within six days of submitting the application file (Article 5 of the CTR). Ethical evaluation is carried out by the National Ethics Committee, which drafts an assessment report in accordance with the procedure laid down in Article 7 of the CTR. A positive scientific (by EOF) and ethical (by National Ethics Committee) assessment of the clinical trial is required for its approval. Medical Devices According to articles 62 of the MDR and 58 of the IVDR, both clinical investigations and per- formance studies are subjected to an authori- sation by the Member State in which the clini- cal investigation or the performance study is to be conducted, following a scientific and ethical review, the latter being performed by an ethics committee, according to the national law. As per above, competent authorities are EOF and the National Ethics Committee. 2.3 Public Availability of the Conduct of a Clinical Trial Greece has no national database for clinical tri- als of medicines or medical devices. A central European database (EudraCT) exists, as pro- vided in article 80 of the CTR.
review, robust clinical data requirement, and clinical trials).
2. Clinical Trials 2.1 Regulation of Clinical Trials Pharmaceuticals
The legal framework applicable to clinical trials in Greece is laid down in the Regulation (EU) No 536/2014( “CTR” ) on clinical trials on phar- maceuticals for human use. The provisions of the CTR were transposed in the Greek legislation by the Joint Ministerial Decision G5a/59676/2016 (Government Gazette Β’ 4131/22.12.2016). In order to conduct a clinical trial in Greece, prior approval from EOF is required following an appli- cation submitted via the EU portal. The application, the clinical trial protocol, the information material addressed to patients, the informed consent form, the labelling, the patient cards, and the insurance contract must be sub- mitted in Greek. The rest of the file documenta- tion may be submitted in English. Medical Devices The legal framework applicable to clinical inves- tigations (or performance studies in the case of in vitro diagnostic medical devices) is set out in Section VI of the MDR, as well as in Section VI of the IVDR on in vitro diagnostic medical devices, as the case may be. In Greece, the MDR and the IVDR are directly applicable in conjunction with the Joint Ministerial Decision DY8d/130648/2009 (Article 15 of the said Deci- sion specified the clinical-related rules).
124 CHAMBERS.COM
Powered by FlippingBook