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Declaration by the applicant pertaining to the application for a Duplex marketing authorisation (Model I) - Duplex with supplementary conditions
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 ...
The MEB: Good medicines used better (short version)
The MEB: Good medicines used better (long version)
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 ...
Obtaining and maintaining an authorisation for the parallel import of an immunological veterinary medicinal product (appendix 1)
Parallel import comparison form
MEB 48: National informed consent application
An Article 10c 'Informed Consent' application ( article 10c of Directive 2001/83/EC) is an application for marketing ...