Non-interventional studies

DEFINITIONS

Non-interventional studies of pharmaceutical products must meet the general conditions described in article 87 of Law 4812, (Government Gazette A' 110/30.06.2021)

The submission of an application for the conduct of non-interventional studies with medicines is made in accordance with the provisions of Art. 9 of Joint Ministerial Decision D3(a) 52922/2025 (Government Gazette B' 230/22.01.2026)

Please note that:

According to par. 2 of Art. 9 of Joint Ministerial Decree D3(a) 52922/2025 (Government Gazette B' 230/22.01.2026), especially in the case of non-interventional drug studies conducted in accordance with EOF circular 82798/22-11-2012, i.e. non-interventional post-authorization safety or efficacy studies (PASS/PAES) imposed by a Competent Authority to be conducted exclusively in Greece, in addition to the supporting documents referred to in par. 1 of Art. 9 of JMD D3(a) 52922/2025, the relevant approval of the E.O.F. is also required.
The above applies to the initial and any modification of the non-interventional study.

USEFUL DOCUMENTS:

Legislation

EOF Circulars

1. ΕΓΚΥΚΛΙΟΣ 82798/22-11-2012
Clarifying Circular on non-interventional studies
2. ΕΓΚΥΚΛΙΟΣ 55480/6-9-2006
NON-INTERVENTIONAL STUDY OF MEDICINES FOR HUMAN USE

In force as regards the requirements (content and forms) of the submission dossier

Submission file forms

Parables:
According to Ministerial Decision DYG3a/G.P 139307/05 (Government Gazette B' 1098/10.08.2006, Art. 19), as amended by DYG3a/G.P 171107 (Government Gazette B' 2689/31.12.2008, Art. 9), the fees for non-interventional studies submitted for evaluation to the EOF are defined as follows:

For approval of a non-interventional study, per study, 2.000,00 euros.
For modification of a non-interventional study, per modification, 1.000,00 euros.
In non-commercial non-interventional studies, the fees are respectively 1.000,00 euros (initial) and 500,00 euros (modification).

Non-interventional studies

CONTACT

SOCIAL MEDIA

USEFUL LINKS