Documents - Marketing authorisation medicines for human use
46 documents Marketing authorisation medicines for human use
- Date
- Relevance
-
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 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 ...
-
GS-list 18
The list of active substances in products that may qualify for sale general sale (GS list) was updated by the MEB on 22 October ...
-
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 ...
-
MEB 43: Two-round assessment policy for national procedures
Limiting the number of assessment rounds ensures that the (legally) stipulated time within which the MEB must make a decision ...
-
MEB 13: Nomenclature of pharmaceutical products
This document describes the requirements which the marketing authorisation holder has to fulfil when submitting a proposal for a ...
-
Declaration for the package leaflet of parallel imported products
-
Explanation of the Interest Form - MEB-ZIN Parallel Procedures pilot
Accelerating patient access to reimbursable innovative medicines has been on the wish list of the government, patient ...
-
List of patient-friendly terms for the package leaflet
In order to optimise the readability of the package leaflet, the MEB has revised the list of patient-friendly terms. The list has ...
-
MEB 21: Statement of ‘abbreviated indications’ on OTC medicinal product packaging
Directive 2001/83/EC discusses European regulations on labelling. In accordance with Article 54(n), the outer packaging of ...