Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK MAHs and the MHRA
This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)
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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.
Updates to this page
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Exceptions and modifications document 바카라 사이트� updates (01 Jan 2025) -Overall updates were made to the document to reflect changes to UK legislation implementing new arrangements for medicines following the Windsor Framework and European Union Updates to GVP Module XVI and Addendum II - Updates throughout to indicate requirements for Category 1 and Category 2 products following the implementation of the Windsor Framework - Other specific updates include: Section I.C.1.4 바카라 사이트� Additional information added for Category 1 products with an associated EU license to consider new information published on the European Medicines web portal and where necessary make changes to the UK authorisation via a variation Section I.C.2.1 바카라 사이트� Additional information added to paragraph 4 regarding withdrawal options for NI as a CMS. Section II.B.2.2 - Information added to last sentence of paragraph 1 regarding the location of the Qualified person for Category 2 products. Section II.B.4.1 바카라 사이트� Addition of Paragraph 3 Section II.B.4.6 바카라 사이트� Addition of Paragraph 2 Sections II.B.4.7 바카라 사이트� New section added Section II.B.4.8 바카라 사이트� Addition of paragraph 3 and 7 Section III.A 바카라 사이트� Paragraph 4 no longer applies to UK authorised products GVP Module V (Summary) 바카라 사이트� sentence added to the end of the 1st paragraph which describes requirements for UK RMP and footnote to the UK specific RMP annex template Section VI.A 바카라 사이트� New paragraph added to describe reporting requirements to for Category 1 products Section VI.C.2.2.12 바카라 사이트� Addition of paragraph 2, section subparagraph 3 Section VI.C.4 Reporting to EudraVigilance 바카라 사이트� Information added in relation to Category 1 products and category 2 products Section VI.App.2.10 -Updated contact details to vigilanceservice@mhra.gov.uk Section VII.A Note added under Paragraph 9 regarding the legal basis of application of a UK authorised product Section VII.C.6.1 - Additional information added for Category 1 products with an associated EU license to consider new information published on the European Medicines web portal and where necessary make changes to the UK authorisation via a variation. Section VIII.A 바카라 사이트� Paragraph 4 added Section VIII.A 바카라 사이트� Paragraph 11 and Paragraph 12 added Section VIII.B.1 바카라 사이트� Additions of Paragraph 1, 2, 5 and 6. Section VIII.B.3 바카라 사이트� Paragraph 4 added Section VIII.B.5.1 바카라 사이트� New section added Section VIII.B.6 바카라 사이트� Paragraph 2 added Section VIII.B.7 바카라 사이트� Paragraph 1 and 2 added Section IX.C.1.2 - Additional information added for Category 1 products with an associated EU license to consider new information published on the European Medicines web portal and where necessary make changes to the UK authorisation via a variation. Section IX.C.4.3 바카라 사이트� New information added to end of section to state that newly triggered procedures on the PRAC agenda do not need to be notified to the licensing authority Section XV.C.2.1 - removal of paragraph referring to centrally authorised products Section XV.B.5.1 - Updated contact details to vigilanceservice@mhra.gov.uk GVP Module XVI : Risk Minimisation measures 바카라 사이트� extensive updates to reflect updates to GVP Module XVI GVP Module XVI Addendum II 바카라 사이트� Extensive updates to reflect updates to GVP Module XVI Addendum II. GVP Annex I 바카라 사이트� Definitions. 바카라 사이트� Amendment to definition of ATMP. Additional definitions 바카라 사이트� concomitant medication, primary endpoint, reference safety information in the context of clinical trials and UK marketing authorisation added.
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Updated 'Guidance note on good pharmacovigilance practices'.
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Changed to add latest version of Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorisation holders and the licensing authority
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Updated to reflect the changes to UK legislation implementing new arrangements for medicines following agreement of the Windsor Framework, and the European Union updates to GVP module XVI. Addendum II Updated to include new contact details.
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First published.