The MHRA has published guidance on the UK qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF), if the UK leaves the EU without a deal. This is a must read for all UK Marketing Authorisation Holders; please contact us if you would like to discuss how Purple Vigilance can help with these requirements. The full guidance can be found by following the link below:
Tag Archives: MHRA
MHRA open public consultation on transposition of Pharmacovigilance Directive 2010/84/EU into UK Law
The MHRA is inviting comments on the transposition of the Pharmacovigilance Directive 2010/84/EU into UK law. The new PV legislation comes into force in July 2012 and the documents provided by the MHRA give an insight into the proposals for UK.
Comments should be provided to the MHRA by 28th February 2012.
More information can be found by the following the link below:
http://www.mhra.gov.uk/Publications/Consultations/Medicinesconsultations/MLXs/CON137667
MHRA publishes timeframes for publication & distribution of updated SPCs and PILs
The MHRA has published an update to the Good Pharmacovigilance Practice section of their website. The update concerns the publication and distribution of updated Summaries of product Characteristics (SPCs) and Patient Information Leaflets (PILs) following safety-related changes. The MHRA recommends specific timeframes for completing activities relating to updated SPCs and PILs, following findings by the GPvP Inspectorate.
It is important for Marketing Authorisation Holders to note the expectations of the MHRA relating to timeframes for publication and distribution of these documents, to ensure timely risk communication to internal and external customers.
More information on the guidance published by the MHRA can be found by following the link below:
MHRA no longer sending ASPRs from literature to MAHs
The MHRA are no longer sending out Anonymised Single Patient Reports (ASPRs)/ Individual Case Safety Reports (ICSRs) from literature to Marketing Authorisation Holders (MAHs). This came about after a review by the BROMI Vigilance Workstream and should increase efficiency for both the MHRA and MAH Pharmacovigilance systems. The MHRA state that the number of ASPRs sent out to companies could be reduced by 33-50%. This will be of particular interest to generic companies that hold numerous Marketing Authorisations in the UK.
The MHRA have published information about this which can be found by following the link below. It is important to continue reporting serious cases from literature in line with the MHRA’s instructions & Volume 9a to ensure continued compliance. If you have any questions about ASPRs and how to manage them, please contact us and we will be happy to help you.
MHRA GPvP Risk Based Inspection Compliance Reports – Due 4th November!
The GPvP Risk Based Inspection Compliance Reports are due for submission to the MHRA by 4th November 2011 – please mark this date in your diary! Completion of the report is not mandatory but the MHRA recommend that Marketing Authorisation Holders do complete one. If you do not submit a completed report the MHRA will assign your company a high risk rating, increasing your chances of a Pharmacovigilance Inspection. More information can be found at
www.mhra.gov.uk/…GoodPharmacovigilancePractice/Riskbasedinspections/index.htm