Europe – Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP

The below Practical Guidance aims to provide procedural and practical guidance regarding submission of changes. It addresses the implications of the withdrawal agreement and the transition period provided for therein.
MAHs and applicants of nationally authorised products for human use need to ensure that the necessary changes are made by the end of the transition period, unless indicated otherwise in the guidance below…