Clinical trials (interventional and non-interventional)
In Greece clinical trials on medical products for human use are conducted upon approval of the National Organization for Medicines (EOF).

According to Ministerial Order ΔΥΓ3/89292, FEK B1973/31-12-2003 (harmonized under Directive 2001/20/EC), the clinical trials fall under two categories:
• Interventional clinical trials
• Non-interventional trials

Applications for approval of clinical trials are submitted to the Division of Pharmaceutical Studies and Research, along with the necessary documents.

Clinical Trials - Interventional
According to Ministerial Order ΔΥΓ3/89292, FEK B1973/31-12-2003, clinical trials are approved by EOF provided that there is a positive opinion from the National Ethics Committee (EED).
Clinical trial (Ministerial Order ΔΥΓ3/89292, FEK B1973/31-12-2003, article 2a) is any investigation in human subjects intended:
    - to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s), and/or
    - to identify any adverse reactions to one or more investigational medicinal product(s) and/or
    - to study absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s)
with the object of ascertaining the safety and/or efficacy of the investigational medicinal products.
For the authorization or amendment of a clinical trial, an application is submitted to EOF, along with all the requested supporting documents.

AMENDMENT:
For the approval of a substantial amendment a positive opinion by the National Ethics Committee is required, according to Ministerial Order ΔΥΓ3/89292, FEK B1973/31-12-2003 (article 9). All the necessary supporting documents (as the case may be) are submitted along with the application and the cover letter.

USEFUL DOCUMENTS:
• Ministerial Order ΔΥΓΑ/79602/25-1-2007
• Ministerial Order ΔΥΓ3/89292, FEK B1973/31-12-2003
• Circulars

  1. Guidance on the conduct of bioavailability/bioequivalence studies (mode of submission of protocol and report of the outcome)
  2. Circular 88148/23-10-2010: Detailed guidelines for the granting of authorization for the conduct of interventional clinical trial and procedures for the notification of a substantial amendment and the declaration of the end of a clinical trial

Forms
List of documents required for the authorization of a clinical trial
• Information
       21.4.2010   Obligations of the persons responsible for the conduct of clinical trials on medicinal products in accordance with the principles of Good Clinical Practice (GCP)
       20.3.2013    Submission of supporting documents in electronic form starting from April 1st, 2013.

NOTES:

  1. Following the submission of a request seeking of information at the EOF Department of Clinical Trials is made by presenting the EudraCT number or the study code given by the Department.
  2. The xml file is filled in through the EUDRACT database by following the pertinent detailed instructions. Applicants should pay special attention to the accuracy of the data entered and a “validation” should follow before the completion of the submission procedure to EOF.
  3. The application in Greek for the approval, amendment or end of a clinical trial should include the same information as in the xml file.
  4. Fees: In accordance with Ministerial Order ΔΥΓ3α/Γ.Π 139307/05 (FEK 1098  10/08/2006 articles 18 and 19) the fees for the clinical trials are as follows:

1. For the approval of (interventional) clinical trial, per trial : 3.000,00 Euros plus 2,4%tax
2. For the amendment of a (interventional) clinical trial, per amendment: 1.500,00 Εuros plus 2,4%tax
3. The fees for the non-commercial interventional trials are 1.500,00 plus 2,4%tax and 750,00 Euros plus 2,4%tax, respectively.

 Non-interventional trials
According to Ministerial Order ΔΥΓ3/89292, FEK B1973/31-12-2003 (aritcle 2), non-interventional trials must fulfil the following criteria:
• the medicinal product(s) is (are) prescribed in the usual manner in accordance with the terms of the marketing authorisation
• the assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice
• the decision for the prescription of the medicine is clearly separated from the decision to include the patient in the study
• no additional diagnostic or monitoring procedures shall be applied to the patients
• epidemiological methods shall be used for the analysis of collected data

The non-interventional trials are governed by article 7 of the precedent Minesterial Order A6/10983/1/1984, FEK B886. For the approval or amendment of a non-interventional trial an application is submitted to EOF along with all requested supporting documents.

Before commencing any regulatory procedure in Greece with regard to non-interventional studies please be kindly informed about the following fundamental prerequisite:
The only type of non-interventional studies that may be submitted to and approved by EOF are the post-authorization safety studies (PASS) and the post-authorization efficacy studies (PAES), which have been imposed by a competent authority either at or after of the time of marketing authorization and will be conducted only in Greece.

USEFUL DOCUMENTS:
•    Ministerial Order ΔΥΓ3/89292 FEK B1973/31-12-2003
•    Circulars

  1. Circular 82798/22-11-2012:  Explanatory circular on non-interventional trials
  2. Circular 55480/6-9-2006: Non-interventional trials on medical products for human use 

Fees:
In accordance with Ministerial Order ΔΥΓ3α/Γ.Π 139307 (FEK 1098/10-08-2006, articles 18 & 19) the fees for the non-interventional clinical trials are as follows:

  1. For the approval of a non-interventional clinical trial, per trial 2.000,00 Euros plus 2,4%tax
  2. For the amendment of a non-interventional clinical trial, per amendment 1.000,00 Euros plus 2,4%tax
  3. The fees for the non-commercial non-interventional trials are 1.000,00 plus 2,4%tax and 500 Euros plus 2,4%tax, respectively