216 documents
License holder registry
The license holder registry contains data about the location where the marketing authorisation holder may perform certain ...
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 ...
Poster Renske ten Ham: Challenges in development and market authorisation of ATMP in Europe
Poster Tahira Nakchedi: Regulatory experience with non-clinical studies of cell-based therapy
Overview of license holders with a license for the importation of a veterinary medicinal product from outside the European Economic Area
This overview lists those parties who have obtained an authorisation for the importation of a veterinary medicine from outside ...
Assessment report novel food status L-fucose
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 ...
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 ...