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

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/c0a0fb32-2f43-4b45-8dfb-9f4946687750
Type: Guidance
Published: December 31, 2020
Updated: February 19, 2025

> The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance regarding Good Pharmacovigilance Practices (GVP) following the UK's departure from the European Union. GVP represents a critical set of measures designed to ensure the safety monitoring and performance of medicines. While these standards traditionally apply to Marketing Authorisation Holders (MAHs) and regulatory bodies like the European Medicines Agency (EMA), the evolving regulatory landscape necessitates specific adjustments for operations within the United Kingdom. The guidance clarifies that GVP standards cover both centrally and nationally authorized medicinal products. However, with the UK's regulatory autonomy, certain aspects of the EU framework are no longer applicable to the MHRA or UK-based MAHs. In other instances, existing EU guidelines must be interpreted with specific modifications to align with UK law. The primary regulatory framework is the established GVP system, now adapted for the UK context. While no specific company violations or inspection dates are cited in this general guidance, the document serves as a compliance roadmap. MAHs are required to review their pharmacovigilance systems to ensure they comply with the MHRA’s specific interpretations. This includes distinguishing between EU-wide requirements and those specifically tailored for the UK market to maintain the safety and integrity of medicinal products.

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## Content

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 to be read subject to modification.

## Attachments

- [Guidance note on good pharmacovigilance practices](https://assets.publishing.service.gov.uk/media/67ab3564d41dfb0b59cec46d/Exceptions_and_modifications_to_the_EU_guidance_on_good_pharmacovigilance_practices_that_apply_to_UK_MAHs.pdf)