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
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
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
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
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.
