Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorization holders (MAHs)

This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP) in a no-deal Brexit.

As part of their ongoing Brexit advice, the UK Medicines & Healthcare products Regulatory Agency (MHRA) released a guidance note entitled "Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorization holders" on the 26th September 2019. This guidance describes the aspects of the EU guidance on GVP that will no longer apply to the MHRA and UK MAHs or are to be read subject to modification in a no-deal Brexit.

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