H-1135 Budapest, Szabolcs utca 33.

Tel.: (1) 8869-300, E-mail: ogyei@ogyei.gov.hu

Mail: 1372 P.O. Box: 450.


Mellékhatás bejelentő
Forgalmazói regisztráció

Modification of non-interventional studies

Submission procedure of NIS Amendments:

Sponsor may modify an approved non-investigational study. In the case of a substantial modification of the protocol the sponsor should apply for a modified approvement at OGYÉI.

One copy of the documentation will be sent to the Scientific and Research Ethics Committee of Medical Research Council (CEC) for ethical review and opinion by OGYÉI.

Documentation should be submitted in two identical copies, preferably on 2 CDs. Please indicate the ID of submission in the cover letter: 2908.

Deadline of issue of the approval: 30 days. Process begins at the date of submitting the application. Clock stops if completion of documents is needed.

Substantial amendments:

According to rules it should be considered as substantial modification if

- modification may affect the safety of patients

- modification may change the rationale of the study

- modification concerns the protocol

- new results make it necessary to modify the Patient Inform Leaflet

On the basis of criteria mentioned above OGYÉI considers it as a substantial modification:

- if the modification of protocol results in modification of Patient Inform Leaflet

- if SmPC of administered medicine has been changed because of safety information

- if the modification affects the study essentially

- if the coordinator principal investigator of the study changes or the study site of coordinator principal investigator changes

Non-substantial amendments:

In the case of non-substantial amendments sponsor should submit a notification to OGYÉI (free of charge). Deadline of acquiescence: 30 days.

Fees charged for authorization of substantial amendments:

Amount of 80.000 HUF has to be paidto the account of OGYÉI (10032000-00290050-00000000).

Approvement of substantial modifications of a non commercial study is free of charge.

Last updated: 2015.03.12 09:37