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Declaration by the applicant pertaining to the application for a Duplex marketing authorisation (Model I) - Duplex with supplementary conditions

Directive | 18-06-2018

MEB 16: Duplex marketing authorisation

A duplex marketing authorisation is a marketing authorisation for a product of which the dossier is identical to that of a ...

Policy document | 18-06-2018

The MEB: Good medicines used better (short version)

Video | 13-06-2018

The MEB: Good medicines used better (long version)

Video | 13-06-2018

MEB 45: National implementation of additional risk minimisation measures

An important element of a risk management plan (RMP) is a clear description of the necessary measures in order to minimise the ...

Policy document | 11-06-2018

Obtaining and maintaining an authorisation for the parallel import of an immunological veterinary medicinal product (appendix 1)

Form | 28-05-2018

Parallel import comparison form

Form | 03-04-2018

MEB 48: National informed consent application

An Article 10c 'Informed Consent' application ( article 10c of Directive 2001/83/EC)  is an application for marketing ...

Policy document | 02-03-2018

Previous versions of the Dutch QRD-template

Form | 01-01-2018

Parallel import dossier structure

Publication | 01-01-2018

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