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HMA - CMDh - Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP

17th February 2021

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 published by the European Commission

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. Implications of the IE/NI protocol are addressed separately in the CMDh Practical Guidance on the implementation of the Protocol on Ireland/Northern Ireland for medicinal products for human use approved via MRP/DCP.

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