Questions and Answers to Stakeholders on the Implementation of the Protocol on Ireland / Northern Ireland

On 11 December 2020 the EMA Published Revision 2 of the Q&A Document.

The information provided in this Q&A document complements the Notice to Stakeholders on the Withdrawal of the UK and EU rules for medicinal products for human use and veterinary medical products and the EMA Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralized procedure.

This practical guidance document only reflects the situation as laid down in legal provisions in force on the date of its publication, and without prejudice to any of the ongoing discussions between the European Union and the UK concerning the application of the Union acquis concerning medicinal products with respect to Northern Ireland after the transition period, in light of the particular challenges that small markets historically dependent on medicines supplied from or through Great Britain are facing. In this regard it has to be kept in mind that the EMA is not participating in any of the negotiations between the Union and the UK that aim at solving – before the end of 2020 - the particular challenges that small markets face that historically are dependent on medicines supplied from or through Great Britain, notably Northern Ireland.

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