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UK MHRA On ‘Steep Learning Curve’ For Post-Brexit Safety Reporting

‘Adapts’ Safety Data Requirements Based On What Works Well For It To Keep Updated

Executive Summary

The UK medicines regulator has made changes to its guideline on pharmacovigilance procedures to ensure it can continue receiving all necessary safety information in a timely manner now that it has left the EU. It has also explained the safety reporting procedures for products marketed in Northern Ireland, which are still governed by EU medicines regulations. 

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