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:
The European Medicines Agency (EMA), with the agreement of the European Commission, have announced that the pilot phase of monitoring data in EudraVigilance for safety signals will be extended. The pilot was initially planned to last for one year but has been extended beyond February 2019.
The pilot started on 22 February 2018 focusing on active substances included in ‘List of active substances involved in the pilot on signal detection in EudraVigilance by marketing authorisation holders’. Until further notice by the EMA, MAHs with an active substance or combination included on the list should continue performing signal detection in EudraVigilance for these substances.
The EMA plans to survey the MAHs involved in the pilot phase on their experience; they will use the findings to prepare a report by the end of September 2019.
A decision on the next phase of implementation, including the products to be included and the date of coming into effect, will be communicated to stakeholders by the EMA by the end of December 2019.
Regulatory guidance on the detection and reporting of signals from EudraVigilance is provided in Good Vigilance Practice (GVP) Module IX on Signal Management. Purple Vigilance Limited can assist with signal detection and management activities, please contact us for more information.
In 2016 I was asked to deliver a lecture, on the role and responsibilities of the EU QPPV and maintaining Pharmacovigilance systems, as part of the Cardiff University/BRAPP Post Graduate course in Pharmaceutical Medicine. I was proud to be asked, but apprehensive as I had not lectured before. I accepted the offer and set to work on my presentation, drawing on the knowledge and experience in Pharmacovigilance I have gained since 2001, along with the Good Pharmacovigilance Practice (GVP) Modules I and II.
My first lecture, delivered in October 2016, was a nerve-wracking but rewarding experience, and I was surprised how much I enjoyed it. The discussion with the delegates was really interesting; providing insight on how Pharmacovigilance legislative requirements impact the day to day role of practicing physicians.
I was excited to be asked back in 2017 and 2018 to deliver my lecture again, each time with some minor updates following changes in guidance and my experience. I will be presenting again this year, but at this time I’m not sure what I will say, Brexit will no doubt have an impact on the content of my lecture! Nonetheless I am excited to be involved and to be able to share my experiences; I would recommend taking up an opportunity that might at first seem daunting, as it is likely to be very rewarding.
Ruth Casserley, 10/01/2019
We are pleased to announce that as of today, Purple Vigilance is able to offer a new service; we can now assist Marketing Authorisation Holders (MAHs) and Sponsors with data entry and maintenance of products details in the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD).
Background on the XEVMPD
One of the key deliverables of the 2010 Pharmacovigilance legislation relates to the submission by MAHs of information about medicines to the European Medicines Agency (EMA). The requirement is described in Article 57(2) of Regulation (EC) No 1235/2010.
MAHs to submit information to the EMA electronically on all medicinal products for human use authorised in the European Union by 2 July 2012, using this format;
- MAHs to inform the EMA of any new or varied marketing authorisations granted in the EU as of 2 July 2012, using this format.
Purple Vigilance can enter the details of your products onto XEVMPD and provide on-going maintenance to ensure continued compliance.
Contact us now to discuss your requirements!
Purple Vigilance is 1 year old! It’s been a year since Purple Vigilance was incorporated and what an eventful year it has been. 2012 has seen the implementation of biggest change in EU Pharmacovigilance (PV) legislation and regulation of human medicines in the European Union since 1995.
Purple Vigilance has completed a wide range of projects in the last year, from training on the new legislation to preparing templates for common PV documents. Purple Vigilance is providing on-going PV support to several companies in addition to EU QPPV services.
I would like to thank all of Purple Vigilance’s clients for your business and kind support over the last year – you have helped the business to be a success!
If your organisation has any PV needs, however small, please do not hesitate to contact us for advice.
The EMA has published a Q and A document on transitional arrangements for the new pharmacovigilance legislation in preparation for July 2012.
The document addresses some of the questions that Marketing Authorisation Holders may have on areas such as the pharmacovigilance system master file, risk management plans and the submission of renewals.
The document can be found by following the link below:
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:
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:
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.
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