Veterinary Legislation

HMA-v ideas for improvement of veterinary legislation

 

Task Force on Veterinary Medicines Legislation

Focus Group on Improvement of Veterinary Legislation
Report 14 March 2011 meeting, Maisons-Alfort, France

Task Force on Veterinary Medicines Legislation
Covering note - Stakeholders consultation. Published 19 June 2009

Task Force on Veterinary Medicines Legislation
Stakeholder consultation. Published 19 June 2009

Report on Joint EMA/HMA Workshop on Requirements for the Authorisation of Vaccines

Overview
A “Joint EMA/HMA Workshop on requirements for the authorisation of veterinary vaccines in the EU” took place on the 25 Mach 2015. The format of the workshop included presentations from speakers representing regulatory authorities in the EU and USA, including vaccine experts, the European Commission and industry. Breakout sessions were introduced to discuss key themes on vaccine availability and requirements. The key question addressed at the meeting was if requirements for marketing authorisation of vaccines in the EU were considered proportionate to the benefits and risks of this type of product.  The main conclusions were as follows:

 

  • lack of availability of products for limited markets (MUMS)
  • significant challenges remain in terms of making vaccines against epizootic diseases available in emergency situations
  • an overall perception on fewer EU availability vaccines for major diseases with a less clear impact on animal health
  • the need to ensure the promotion of availability with the result in more products on the market and expanding the range of diseases that can be effectively prevented

The HMA discussed about the conclusions and recommendations of the Workshop during its 80th and 81st meetings respectively in May in Ljubljana, Slovenia and in July in Luxembourg. The HMA agreed to follow up the issues highlighted by the workshop and build long-term objectives into the multi-annual work program as specific actions.