Fees
FEEs for the AUTHORISATION procedure - HUNGARY
According to Act XCV of 2005. (Annex 1.III.G.)
There is no fee for the authorisation of non-commercial clinical trials.
III.G.1. |
Clinical trial authorisation if the trial is planned to be conducted only in Hungary |
HUF 580 000 |
III.G.2. |
Low-intervention clinical trial |
HUF 580 000 |
III.G.3. |
Clinical trial authorisation where the trial is planned to be conducted in more than one Member State |
HUF 750 000 |
III.G.4. |
Authorisation procedure under III.G.1. and III.G.2. if the applicant requests an assessment only for Part I |
HUF 435 000 |
III.G.5. |
Authorisation procedure under III.G.1 and III.G.2, if the applicant requests an assessment only for part II |
HUF 145 000 |
III.G.6. |
Authorisation procedure under III.G.3, if the applicant only requests an assessment for part I |
HUF 562 500 |
III.G.7. |
Authorisation procedure under III.G.3 if the applicant requests an assessment only for Part II |
HUF 187 500 |
III.G.8. |
Additional fee to be paid in addition to the fees for the authorisation procedure under III.G.2, III.G.3, III.G.4 and III.G.6, if Hungary is the Reporting Member State |
HUF 500 000 |
III.G.9. |
Substantial modification of the clinical trial in respect of an aspect covered by Part I of the assessment report |
HUF 110 000 |
III.G.10. |
Substantial modification of the clinical trial in respect of the aspect covered by Part II of the assessment report |
HUF 110 000 |
III.G.11. |
Substantial modification of the clinical trial in respect of the aspect covered by Parts I and II of the assessment report |
HUF 220 000 |
III.G.12. |
Additional fee to be paid in addition to the fee for the authorisation procedure under III.G.9. and III.G.11. if Hungary is the Reporting Member State |
HUF 90 000 |
III.G.13. |
Procedure for subsequent addition of a Member State concerned if Hungary is the Reporting Member State |
HUF 200 000 |
III.G.14. |
Fee for the procedure for the assessment in cooperation with the Member States pursuant to Article 44 of Regulation (EU) No 536/2014 of the European Parliament and of the Council, where Hungary is the Safety Assessing Member State (saMS) |
HUF 500 000 |
Unofficial translation.