Pharmacovigilance Working Party - veterinary (PhVWP-v)
The CVMP agreed on 20 June 1995 on the creation of the PhVWP-V focused on the development of pharmacovigilance guidance and on the provision of advice in relation to pharmacovigilance issues for specific veterinary medicinal products, in particular for centrally authorised veterinary medicinal products. The Member States requested in 2006 to re-confirm the role of the PhVWP-V for the overall surveillance of the adverse events concerning veterinary medicinal products authorised in the EU in view of the legislative requirements for electronic reporting and the centralisation of the adverse event data for all veterinary medicinal products in the central EU database (EudraVigilance Veterinary (EVVet)).
The PhVWP-V has a dual role in advising the CVMP as well as the Member States, ensuring the best use of pharmacovigilance resources available in the European Union as per the provisions foreseen in Regulation No 726/2004 Art.53. The responsibility for recommending decision and action for centrally authorised products remains on CVMP and the responsibility for decision and action for products authorised by the national, mutual recognition or decentralised procedures remains on the Member States, and the reporting lines from the PhVWP-V will reflect this.
Members and Representatives
- Veterinary working party.
- One member per Member State, experts nominated by Heads of Agencies in liaison with CVMP members on the basis of their expertise.
- The chair (Lisbet Vesterager Borge (DK)) and vice chair (Baukje Schat) are elected by the members of the CVMP for a term of three years, which may be renewed.
- At least 6 meetings times per year
- The EMA secretariat shall provide technical, scientific and administrative support to the working party. Raquel Gopal, European Medicines Agency, UK
- E-Mail: email@example.com
Activities and achievements
The PhVWP-V work plan is published annually on the EMA PhVWP-V webpage.
Strengthening regulatory sanctions to ensure that veterinary Marketing Authorisation Holders (MAHs) meet vigilance responsibilities for their products, using guidance, regulatory powers and pharmacovigilance inspections
At HMA Warsaw in July 2011 the HMA concluded a discussion on a common document, elaborating on various aspects to be considered by the European Commission in the forthcoming process of revision of the EU veterinary legislation. The paper is now published on the HMA website. Efforts continued to be made to strengthen communication between the PhVWP-V and PhV Inspectors working group to prepare for PhV inspections and a training session was held for pharmacovigilance assessors and inspectors in relation to this.
HMA also adopted a Veterinary Incident Management Plan for Veterinary Medicines (IMP) to be applied in a two year pilot phase.
Raising adverse drug reaction (ADR) reporting levels by veterinarians and farmers
The veterinary Pharmacovigilance Working Party (PhVWP(v)) developed a reflection paper on pharmacovigilance communication concerning veterinary medicinal products (EMA/CVMP/PhVWP/536313/2011)
Raising adverse event reporting levels by veterinarians and farmers has been designated a priority area of Strengthened Surveillance in regard to veterinary medicinal products. Actions to implement the objective were discussed in detail and a number of actions are included in the European Surveillance Strategy Working Group Action Plan. Further discussion on the implementation of this priority action will take place at the ESS WG meetings throughout 2012. Member States’ input will at some point be requested to collect experience on what works or doesn’t work to raise reporting levels.
PhVWP(v) will continue the development of the reflection paper on pharmacovigilance communication
Simplifying veterinary reporting process; taking forward development of EudraVigilance (EV) Vet and systems for electronic ADR reporting
The Committee for Medicinal Products for Veterinary use (CVMP) recommendation for the basic surveillance of EudraVigilance Veterinary (EVVet) data (EMA/385081/2010) was adopted in February 2011 and implemented in August 2011.
PhVWP(v) provided advice to the Joint Implementation Group (JIG) for the continued development of EVVet 3 via the EVVet Vet JIG technical advisory group.
The annual review of the fourth revision of the Combined VeDDRA List of Clinical Terms for Reporting Suspected Adverse Reactions in Animals and Humans to Veterinary Medicinal Products (EMEA/CVMP/10418/2009), and also the List of Species and Breeds (EMEA/CVMP/553/03), was undertaken
Good progress was made to develop the concepts for a risk/pharmacovigilance based approach and signal detection methods for surveillance of veterinary medicinal products.
PhVWP(v) discussed and responded to requests for advice from CVMP and from Member States, on a variety of topics; including further updates on Pregsure BVD and bovine neonatal pancytopenia was a major issue.
PhvWP(v) will promote and develop the use of EudraVigilance Veterinary (EVVet) and the EVVet DataWarehouse in case of non-urgent safety reports and rapid alerts and for the systematic surveillance of adverse events in particular for non-centrally authorised products.
PhvWP(v) will continue to elaborate the principles for a risk/pharmacovigilance based approach to, and signal detection for, surveillance of veterinary medicinal products, for the update of the CVMP recommendation for the basic surveillance of EVVet data.
PhVWP(v) will continue supporting EMA in the development of EV VET3 together with the EVVet Joint Implementation Group.
Key documents list
- General pharmacovigilance guidance documents are available via the EMA website on the following topics:
- Basic surveillance of EudraVigilance Veterinary data
- Periodic safety update reports (PSURs) of veterinary medicinal products
- Adverse event reporting A simple guide to reporting adverse reactions
- Pharmacovigilance communication
- Triggering pharmacovigilance investigations
- Causality assessment
- Question and answer documents
- Guidance and forms for reporting adverse events
- EudraVigilance Veterinary and
- Access policy
- Data surveillance
- Veterinary Dictionary for Drug Related Affairs (VeDDRA) terminology
- Controlled terminology and data elements