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License holder registry

The license holder registry contains data about the location where the marketing authorisation holder may perform certain ...

Publication | 12-09-2019

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 ...

Publication | 10-07-2019

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 ...

Policy document | 28-06-2019

Poster Renske ten Ham: Challenges in development and market authorisation of ATMP in Europe

Publication | 04-06-2019

Poster Tahira Nakchedi: Regulatory experience with non-clinical studies of cell-based therapy

Publication | 04-06-2019

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 ...

Publication | 24-05-2019

Assessment report novel food status L-fucose

Report | 24-05-2019

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 ...

Policy document | 10-05-2019

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 ...

Policy document | 10-05-2019

Declaration on modification of information in the printed SmPC and package leaflet pertaining to patented indications

Form | 01-05-2019