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

On 5 March 2021 the EMA issued additional practical Q&A guidance on the applicable rules in Northern Ireland after the transition period with respect to EMA activities and medicinal products for human and veterinary use within the framework of the centralized procedure.

The information provided in this questions and answers document complements the Notice to Stakeholders on the Withdrawal of the United Kingdom 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 Union and the UK concerning the application of the Union acquis concerning medicinal products in respect of Northern Ireland after the transition period, in light of the particular challenges that small markets historically dependent on medicines supply from or through Great Britain are facing. In this regard it has to be borne 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 as that historically are dependent on medicines supply from or through Great Britain, notably Northern Ireland.

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