EMA and MHRA Preparing for No Deal Brexit


EMA and MHRA After Brexit?

Now that Brexit has been delayed, there is still no guarantee of a deal. The extension will be until April 12 if the withdrawal agreement is not approved by the UK House of Commons by March 29, and until May 22 if it is. During this time, the UK will continue to be a Member State in the EU. The European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) are preparing for the possibility of a no deal Brexit. The EMA headquarters will be moving from London to Amsterdam as London will no longer be part of the EMA after Brexit. Regulatory document submissions due to the EMA need to be made prior to the end of the Brexit date.

Stakeholders in the UK would need to submit regulatory and notifications directly to the MHRA. Stakeholder affected by this include:

  • Pharmaceutical companies submitting regulatory documents

  • Sponsors submitting clinical trial applications

  • Stakeholders submitting Individual Case Safety Reports (ICSRs) or suspected unexpected serious adverse reactions (SUSARs)

Submissions are to be made electronically through the MHRA Gateway.

How has Brexit impacted you so far?


- The Clinical Pathways Team

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