MHRA - Updates to PV Exceptions and Modifications Document

20th February 2025

MHRA - Updates to PV Exceptions and Modifications Document

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

Updates listed on MHRA website (19th Feb 2025)

Exceptions and modifications document – 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 – 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 – 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 – Addition of Paragraph 3 Section II.B.4.6 – Addition of Paragraph 2

Sections II.B.4.7 – New section added Section II.B.4.8 – Addition of paragraph 3 and 7 Section III.A – Paragraph 4 no longer applies to UK authorised products GVP Module V (Summary) – 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 – New paragraph added to describe reporting requirements to for Category 1 products

Section VI.C.2.2.12 – Addition of paragraph 2, section subparagraph 3

Section VI.C.4 Reporting to EudraVigilance – 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 – Paragraph 4 added

Section VIII.A – Paragraph 11 and Paragraph 12 added

Section VIII.B.1 – Additions of Paragraph 1, 2, 5 and 6.

Section VIII.B.3 – Paragraph 4 added Section VIII.B.5.1 – New section added

Section VIII.B.6 – Paragraph 2 added Section VIII.B.7 – 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 – 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 – extensive updates to reflect updates to

GVP Module XVI

GVP Module XVI Addendum II – Extensive updates to reflect updates to

GVP Module XVI Addendum II.

GVP Annex I – Definitions. – Amendment to definition of ATMP. Additional definitions – concomitant medication, primary endpoint, reference safety information in the context of clinical trials and UK marketing authorisation added.

Back to Recent News