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MAGYAR

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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.


Last updated: 2022.11.17 15:30