217 documents
Request for consultation medical device
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 ...