H-1051 Budapest, Zrínyi u. 3.

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

Mail: 1372 P.O. Box: 450.

MAGYAR

Decentralized Procedure (DCP)

DCP is used when the medicinal product being simultaneously applied in several Member States for a marketing authorisation has not been authorised in any Member State in the EEA (European Ecoomic Area) so far.

Hungary may act as:

• Hungary as Reference Member State (RMS): the documentation submitted is primarily assessed by the National Institute of Pharmacy;

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

DCP-RMS-New application flow chart

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During te decentralized procedure from all Member States of the EEA Hungary is chosen by the applicant to act as Reference Member State, accordingly the documentation which has been primarily approved by the National Institute of Pharmacy will be - besides continuous consultation - assessed by the other Member States simultaneously.

DCP-CMS-New application flow chart

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The applicant choses one country from the Member States of the EEA to be the Reference Member State – the competent authority of this country will primarily approve the documentation of the new application. All other Member States involved in the procedure will simultaneously assess the documentation besides continuous consultation.

Validation criterions of 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

Applicants have to submit the data defined below if Hungary is requested to be the Reference Member State in a DCP/MRP:

Last updated: 2008.08.18 21:46