Pharmacovigilance Risk Assessment Committee

(asked on 22nd September 2020) - View Source

Question to the Department of Health and Social Care:

To ask Her Majesty's Government how they intend to cooperate with the European Medicines Agency's Pharmacovigilance Risk Assessment Committee from 1 January 2021; whether this cooperation will include (1) participating in the Committee's reviews, and (2) accepting the Committee's findings; and if so, what level of participation in the decision making process they foresee.


Answered by
Lord Bethell Portrait
Lord Bethell
This question was answered on 7th October 2020

The United Kingdom published its approach to the Future Relationship with the European Union in February 2020. The approach set outs the UK’s commitments to facilitating trade in medicinal products and supporting high levels of patient safety.

After the transition period, we will ensure patients in the UK are not disadvantaged and continue to be able to access the best and most innovative medicines that are safe. We want patients to be reassured that their safety will be protected through the strongest regulatory framework.

From January 2021, the safety issues that are considered by the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC), and the outcomes of the PRAC discussions, which are made publicly available, will be closely monitored and, where appropriate, we will take into account the decisions of the PRAC with regards to safety measures that are implemented for the UK.

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