Fees

III.G.1.

Clinical trial authorisation if the trial is planned to be conducted only in Hungary

1 740 000 Ft

III.G.2.

Low-intervention clinical trial

1 740 000 Ft

III.G.3.

Clinical trial authorisation where the trial is planned to be conducted in more than one Member State

2 250 000 Ft

III.G.4.

Authorisation procedure under III.G.1. and III.G.2. if the applicant requests an assessment only for Part I

1 305 000 Ft

III.G.5.

Authorisation procedure under III.G.1 and III.G.2, if the applicant requests an assessment only for part II

435 000 Ft

III.G.6.

Authorisation procedure under III.G.3, if the applicant only requests an assessment for part I

1 687 500 Ft

III.G.7.

Authorisation procedure under III.G.3 if the applicant requests an assessment only for Part II

562 500 Ft

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

800 000 Ft

III.G.9.

Substantial modification of the clinical trial in respect of an aspect covered by Part I of the assessment report

330 000 Ft

III.G.10.

Substantial modification of the clinical trial in respect of the aspect covered by Part II of the assessment report

330 000 Ft

III.G.11.

Substantial modification of the clinical trial in respect of the aspect covered by Parts I and II of the assessment report

660 000 Ft

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 (unless the study is planned to be conducted only in Hungary)

120 000 Ft

III.G.13.

Procedure for subsequent addition of a Member State concerned if Hungary is the Reporting Member State

600 000 Ft

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)

675 000 Ft