217 documents
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 ...
MEB 44: Direct Healthcare Professional Communications (DHPCs)
This document is based on the Guideline on Good Pharmacovigilance Practices (GVP) Module XV – Safety communication, and is aimed ...
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 ...
Form to request withdrawal of a marketing authorisation
Companies may decide to have their marketing authorisation withdrawn for various reasons. A withdrawal form has been created so ...