QUESTIONS & ANSWERS
Has Hungary initiated National legal steps (e.g. Act of Parliament, Decree, etc) in order to adopt the EU CTR 536/2014 into the National legal framework?
Legislative harmonization is ongoing. The Act XCV of 2005 has already been amended.
What national evaluation fees are planned to be charged?
Fees are set out in Annex 1 III.G.1-14 of Act XCV of 2005.
Does the Institute plan to operate its own IT system in case only national documents have to be submitted? Or will the company gate continue to be used for this purpose?
Clinical trials planned under Regulation (EU) No 536/2014 shall be submitted through CTIS.
Applications submitted according to Directive 2001/20 / EC are requested as usual during the transitional period.
Will both OGYÉI and ETT-KFEB have access to the CTIS system?
Yes. It is planned that OGYÉI and ETT-KFEB will both have access to PART I and also to PART II submissions.
Will there be an “interface” between CTIS and the OGYÉI database?
It is planned that there will be an API between CTIS and the new system which is under development in OGYÉI.
Does the Institute plan to organize a training in connection with the introduction of the new CTIS system?
Yes. A training is planned for the fall of 2021. More information will be published on our website.
Does OGYÉI plan to introduce shorter deadlines for early phase investigations?
OGYÉI will make every effort to shorten these deadlines in practice, but no shorter deadline will be set.
Should EudraLex Volume 10 forms be used when submitting Part II dossiers?
All templates available at https://ec.europa.eu/health/documents/eudralex/vol-10 are applicable but not mandatory. Negotiations on the forms are still ongoing with ETT-KFEB.
Will there be country-specific forms?
Hungary does not plan to introduce country-specific templates.
Is there any other important information about the forms?
It is important to note that we accept both handwritten and electronically signed documents.
The CV of the principal investigator is not obligatory to submit on the EU form, we also accept it in other forms.
Are there any plans to change the operating procedure of the Ethics Committee (ETT-KFEB)?
The operating procedure of the ETT-KFEB will be fully adjusted to the new EU Regulation (more frequent meetings, stronger secretariat).
What is the language requirement in Hungary when the EU CTR 536/2014 will be implemented?
Country-specific documents (PART II) are requested in Hungarian (documents given to patients).
PART I documentation is requested in English for multinational studies, except for the summary of the protocol, which needs to be written in Hungarian.