Documents - Marketing authorisation medicines for human use
47 documents Marketing authorisation medicines for human use
- Date
- Relevance
-
Question and answer document concerning changes not covered by the Variation Regulation 1234/2008 (as amended by Regulation 712/2012)
-
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 ...
-
Declaration by the applicant pertaining to the application for a Duplex marketing authorisation (Model I)
-
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 ...
-
MEB 37: Legal status of supply
This document describes the policy of the Medicines Evaluation Board for awarding a legal status of supply.
-
MEB 14: Parallel importation: marketing authorisation and maintenance
Parallel import is the importation – and subsequent marketing in the Netherlands – of a medicinal product authorised elsewhere in ...
-
Parallel import comparison form
-
MEB 39: Policy for assigning RVG numbers
This document describes the Medicines Evaluation Board policy for assigning RVG numbers. This policy is based on the definitions ...
-
Terms and conditions for package fee and reduced fee for copy DCP application - human products
The term package fee entails that a group of products (each with an individual RVG number) is only billed once at the tariff ...