Prolongation of the pilot on signal detection by MAHs in EudraVigilance

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.

Delivering a Lecture on Pharmacovigilance for Cardiff University/ British Association of Pharmaceutical Physicians (BRAPP)

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

Purple Vigilance can now provide XEVMPD services

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.

It requires:

  • 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’s 1st Anniversary!

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.

New pharmacovigilance legislation comes into force today!

Purple Vigilance joins the EMA in welcoming the start of new European Union legislation on pharmacovigilance. This new piece of legislation aims to promote and protect public health by strengthening the existing Europe-wide system for monitoring the safety and benefit-risk balance of medicines. The new pharmacovigilance legislation is comprised of Directive 2010/84/EU and Regulation (EU) No 1235/2010. A key deliverable for the new legislation was the release of a set of Good Pharmacovigilance Practice (GVP) modules.

On 25 June the EMA published the first set of finalised GVP documents that had been released for public consultation earlier this year. The finalised modules released are as follows:

  • Module I: Pharmacovigilance systems and their quality systems;
  • Module II: Pharmacovigilance systems master files;
  • Module V: Risk management systems;
  • Module VI: Management and reporting of adverse reactions to medicinal products;
  • Module VII: Periodic safety update reports;
  • Module VIII: Post-authorisation safety studies;
  • Module IX: Signal management.

These documents are a must-read for all Marketing Authorisation Holders – more information and modules can be found using the following link.

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/06/news_detail_001546.jsp&mid=WC0b01ac058004d5c1

Purple Vigilance can help you find your way through the legislation and ensure your systems remain compliant, contact us for more information.

 

EMA publishes further Q & A on practical transitional measures for implementation of new PV legislation

The European Medicines Agency (EMA)  has published a further Q and A document on the practical transitional measures for implementation of the new PV legislation.

The document provides information on areas such as the ADR reporting, PSURs, pharmacovigilance system master file, risk management plans and PASS in the period of transition from Volume 9a to the new legislation. A must-read for all Marketing Authorisation Holders!

The document can be found using the link below:

http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2012/05/WC500127658.pdf

European Medicines Agency Publishes Updated Set of Mandatory Article 57(2) Requirements & FAQ Document

The EMA has published an updated set of mandatory Article 57(2) requirements for Marketing Authorisation Holders (MAHs) today. Article 57 relates to the population of the XEVMPD (eXtended EudraVigilance Medicinal Product Dictionary) and the new document details the revised mandatory fields in the XEVMPD that must be populated by 2nd July 2012.

A Frequently Asked Questions document on the eXtended EudraVigilance Medicinal Product Report Message (XEVPRM) has also been published today.

Further information and the documents can be found using the following links:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/03/news_detail_001459.jsp&mid=WC0b01ac058004d5c1

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000336.jsp&mid=WC0b01ac05804d8b2b

Transitional Arrangements for New PV Legislation Published

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:

http://ec.europa.eu/health/files/pharmacovigilance/2012_02_qa_phv.pdf

EMA Releases GVP Modules for Public Consultation

The European Medicines Agency have today released seven of the long awaited good pharmacovigilance practice (GVP) modules for consultation. The modules outline the practical implementation of the new PV legislation that will apply from July 2012, and will make essential reading for all Marketing Authorisation Holders and other interested parties. The remaining nine modules are being developed and will be released later in 2012.

The GVP modules released today are as follows:

  • Module I: Pharmacovigilance systems and their quality systems;
  • Module II: Pharmacovigilance systems master files;
  • Module V: Risk management systems;
  • Module VI: Management and reporting of adverse reactions to medicinal products;
  • Module VII: Periodic safety update reports;
  • Module VIII: Post-authorisation safety studies;
  • Module IX: Signal management.

The consultation closes on 18th April 2012 and the EMA hope to finalise these modules for publication by July 2012.

More information and the draft modules can be found at the following link:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/02/news_detail_001451.jsp&mid=WC0b01ac058004d5c1

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