H-1051 Budapest, Zrínyi u. 3.

Tel.: (1) 8869-300, E-mail: ogyei@ogyei.gov.hu

Mail: 1372 P.O. Box: 450.

MAGYAR

Mututal recognition procedure (MRP)

This procedure is used if the medicinal product being applied for a marketing authorisation has already been authorised in at least one Member State in the EEA – the application is subitted simultaneously in more than one Member State for nationalization.

Hungary may act as:

• Hungary as Reference Member State (RMS): the documentation has already been assessed by the National Institute of Pharmacy and a Marketing Authorisation has already been issued in Hungary;

• Hungary as Concerned Member State (CMS): the documentation submitted, which has already been approved by the RMS, is simultaneously assessed by all competent authorities – on the evidence of the Assessment Report prepared by the RMS.

MRP-RMS-New application flow chart

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The mutual recognition procedure is to be used in order to obtain marketing authorisations in several Member States where the medicinal product in question has received a marketing authorisation in at least one Member State at the time of application.

MRP-CMS-New application flow chart

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The mutual recognition procedure is to be used in order to obtain marketing authorisations in several Member States where the medicinal product in question has received a marketing authorisation in at least one Member State at the time of application.

Validation criterions for new application

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The requirements concerning the submission of application.

Notice to the MAH or person/company authorized for communication on behalf of MAH regarding declaration on pack sizes of medicinal products pending under MR or DC procedure

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You are kindly requested to make a declaration on pack sizes the MAH is going to register and purposing to launch in Hungary as in CMS.

Information concerning RMS-requests in Hungary

Last updated: 2008.08.18 21:25