Exceptions and Modifications to the EU Guidance on Good Pharmacovigilance Practices that Apply to UK Marketing Authorization Holders and the Licensing Authority

On 31 December 2020 the MHRA published a guidance note on GVP.

GVP are a set of measures drawn up to facilitate the performance of pharmacovigilance in the EU.

GVP apply to marketing authorization holders (MAHs), the EMA and medicines regulatory authorities in EU member states. They cover medicines authorized centrally through the EMA as well as medicines authorized at the national level.

This guidance describes the aspects of the EU guidance on GVP that no longer apply to the MHRA and UK MAHs, or are to be read subject to modification.

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