Documents - Marketing authorisation medicines for human use
45 documents Marketing authorisation medicines for human use
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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 ...
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 ...
Previous versions of the Dutch QRD-template
Parallel import dossier structure
Request to the MEB to act as Reference Member State in the Mutual recognition procedure (MRP / Repeat Use Procedure)
A request to the MEB to act as Reference Member State in the Mutual recognition procedure (MRP) should preferably be announced ...
Declaration regarding the technical aspects of the readability of the patient information leaflet for pharmaceutical products for human use
Application for the inclusion of QR code in national procedures
MEB 47: Assessment criteria for combination packages
In policy document MEB 47 the MEB has described terms and conditions to assess applications for combination packages of medicinal ...
MEB 5: Package leaflet of pharmaceutical products
This policy document explains the policy regarding the package leaflet of pharmaceutical products in the Netherlands. Download ...