Documents - Marketing authorisation medicines for human use
46 documents Marketing authorisation medicines for human use
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 ...
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 ...