Documents - Marketing authorisation medicines for human use
47 documents Marketing authorisation medicines for human use
Sort by: Date / Relevance
Declaration by the applicant pertaining to the application for a Duplex marketing authorisation (Model I)
Declaration by the applicant pertaining to the application for a Duplex marketing authorisation (Model I) - Duplex with supplementary conditions
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 ...