Authorisation of non-interventional studies
OGYÉI checks if the protocol supplies the conditions of a non-interventional study:
a) The medicinal product(s) is (are) prescribed in the usual manner in accordance with the terms of the marketing authorisation.
b) The assignment of the patient to a particular therapeutic strategy is not decided in advance by the protocol.
c) The prescription of the medicine is clearly separated from the decision to include the patient in the study.
d) No additional diagnostic or monitoring procedures shall be applied to the patients.
e) Epidemiological methods shall be used for the analysis of collected data.
After validation (i.e. checking if all the obligatory documents are submitted; being made sure that the study supplies the conditions of a non-interventional study) OGYÉI forwards the documents to the Scientific and Research Ethics Committee of Medical Research Council (CEC). CEC performs a control on the protocols, on the ICFs and PILs; especially focusing on the patent’s legal and healthy safety.
Both OGYÉI and CEC are allowed to demand a missing information or document. The clock stops during question-response procedure.
If OGYÉI finds the study correct from scientific aspects and the ETT TUKEB provides a favourable opinion about the study, a decision is done by the Authority.
Deadline of authorisation: 60 days (includes process at CEC)
Address: OGYÉI
Clinical Trials Unit,
Tamasne dr. Nemeth Agnes, Head of Clinical Studies Department,
Zrinyi u. 3.
H-1051 Budapest
Hungary
Fee: 370,000 HUF (includes fee for CEC). Data for money transmission are available on the homepage of OGYÉI.
List of obligatory documents for authorization of a non-interventional study:
All documents must be submitted in Hungarian language except of the original protocol of an international study.
- A prior overview (a short questionnaire about the non-interventional study’s subtype). Attached on homepage of OGYÉI.
- The original protocol
- A summary of protocol in Hungarian language
- CV of the principal investigator or of coordinator principal investigator in the case of a multicenter study
- Protocol signature of principal investigator or of coordinator principal investigator in the case of a multicenter study
- List of sites and the name(s) of investigator(s) at each site
- Declaration of (coordinator) principal investigator about the site(s) being appropriate for the study; about the fact that the studies are notified to the head of the medical corp where the study is carried out (see a special notification leaflet as an enclosure of the Regulation of Health Minister 23/2002).
- Patients Information Leaflet (PIL) in Hungarian language
- Informed Consent Form (ICF) in Hungarian language
- Plan of recruitment (if adequate)
- Certificate of bank transfer
Documentation should be submitted in two identical copies, preferably on 2 CDs. Please present the ID of submission in the cover letter: 2907
