UK – Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK MAHs and the MHRA

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26 mars 2025

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ELSIBI

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OpenEdition

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info:eu-repo/semantics/openAccess



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« UK – Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK MAHs and the MHRA », ELSIBI, ID : 10.58079/13knn


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Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the EU. GVP apply to marketing authorisation holders (MAHs), the European Medicines Agency and medicines regulatory authorities in EU member states. They cover medicines authorised centrally through the EMA as well as medicines authorised at 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...

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