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!

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

Public Consultation on Implementing Measures of New PV Legislation

The European Commission is seeking the views of stakeholders on the implementing measures for the performance of the new activities that were introduced by the amended Pharmacovigilance legislation.

The public consultation on these measures is open to all – do not miss the opportunity to have your say and gain further insight into the new Pharmacovigilance legislation that comes into force in July 2012.

The concept paper and more information on how to provide your feedback can be found by following the link below.  The deadline for comments is 7th November 2011.

http://ec.europa.eu/health/human-use/pharmacovigilance/developments/index_en.htm