H-1135 Budapest, Szabolcs utca 33.

Tel.: (1) 8869-300, General information: 1812

E-mail: info@egeszsegvonal.gov.hu

Mail: 1372 P.O. Box: 450.

MAGYAR

Mellékhatás bejelentő
NOR keresőfelület Minőségi kifogás
magisztrális gyógyszerek

Email-addresses for submitting the final national translations

The Hungarian translations – with regards to the type of procedure – have to be submitted to the below email-addresses:

MRP/DCP

National

Type of procedure

Hungary

CMS (MRP/DCP)

RMS (MRP/DCP)

NATIONAL

New application

mrp-dcp-new-cms@ogyei.gov.hu

AND

kiszo@nngyk.gov.hu

mrp-dcp-new-rms@ogyei.gov.hu

AND

kiszo@nngyk.gov.hu

The texts are part of the application and are not necessary to be submitted again.

Renewal

mrp-dcp-renew-cms@ogyei.gov.hu

mrp-dcp-renew-rms@ogyei.gov.hu

The texts are part of the application and are not necessary to be submitted again.

Variation

mrp-dcp-var-cms@ogyei.gov.hu*

mrp-dcp-var-rms@nngyk.gov.hu*

The texts are part of the application and are not necessary to be submitted again.


* In case of MRP-IB and MRP-IA variations the English and Hungarian texts are to be submitted as part of the application in MS Word format with tracked changes. In case of MRP-II variations the above email-addresses apply at the end of the procedure.

 

At the end of an MRP/DCP (New Application) you are kindly requested to submit the below documents as well without which the national phase cannot be initiated:

Please refer to the final accepted invented name and procedure number in the subject of your email.

Last updated: 2021.05.25 15:48