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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

License holder registry

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

Publication | 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

Product types and fees, veterinary

Publication | 26-04-2019

Form comparing the veterinary medicinal product that is to be imported in parallel against the reference veterinary medicinal product

Form | 15-02-2019

Certificate of a Pharmaceutical Product - application instructions

Form | 01-01-2019