Europe – Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure

This practical guidance complements Notice to stakeholders – withdrawal of the United Kingdom and EU rules for medicinal products for human use and veterinary medicinal products, which has been drafted jointly by the European Commission and EMA and is available on the EMA website.

The below Practical Guidance aims to provide procedural and practical guidance regarding submission of changes and related fees. It has been updated to address the implications of the withdrawal agreement and the transition period provided for therein. Additional considerations with regards to products placed on the market before the end of the transition period and the applicable rules in Northern Ireland after the end of the transition period are addressed in parts B and C of the EC/EMA Notice, respectively.

MAHs and applicants of centrally authorised products for human or veterinary use need to ensure that the necessary changes are made by the end of transition period, unless indicated otherwise in the guidance below…

WITHDRAWAL OF THE UNITED KINGDOM AND EU RULES FOR MEDICINAL PRODUCTS FOR HUMAN USE AND VETERINARY MEDICINAL PRODUCTS