The Process of National Marketing Authorisation Renewal

Applications for renewals of marketing authorisation if they have not been submitted so far – should be presented according to §5. (7) of the XCV Medicines Act of 2005 and the §31 of Decree No. 52 of 18 November, 2005 of the Minister of Health and submitted 9 months before the expiry of MA.

The following documentation should be attached to the application:

In paper

A signed copy of completedApplication Form for Renewal of a Marketing Authorisation (http://ec.europa.eu/health/files/eudralex/vol-2/2014-06_nta_renewal.pdf)

Electronic way

• all of the documents listed in the annexes of the Application Form

o Module 1

o Module 2

• Valid quality specification concerning the product

• Proof of payment according to the table of fees (https://ogyei.gov.hu/dynamic/dijtabl20140401.pdf) and the additional informations (https://ogyei.gov.hu/kiegeszito_tajekoztatas/)

If the product information is changed, please submit it in tracked Word format

These should be submitted in electronic (CD/DVD), eCTD or NEES (Non eCTD Electronic Submission) format in 1 copy.

If the medicinal product has two or more strengths, please indicate them in the name of the files.

Please note that variations should be applied for independently, in frame of variation procedure.

Administrative renewal application should be submitted according to the relevant guideline of EMA. http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Renewal/CMDh_004_2005_Rev12_2015_07_clean.pdf

In the international procedures please contact us via the following e-mail addresses:

mrp-dcp-renew-cms@nngyk.gov.hu– MRP (CMS Hungary) Renewal,
mrp-dcp-renew-rms@nngyk.gov.hu– MRP (RMS Hungary) Renewal