Plan to facilitate timely access to the EU market
An action plan to increase the availability of veterinary vaccines in the EU has been published by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA).
The plan contains 13 initiatives to facilitate timely access to the EU market for new or improved veterinary vaccines.
This includes:
- a website to promote communication on veterinary vaccine availability
- a steering group to oversee progress
- training opportunities in the area of veterinary vaccines
- guidance on standards for the manufacture of autogenous vaccines
As well as protecting animal health, veterinary vaccines protect human health by ensuring safe food supplies and preventing animal-to-human transmission of infectious diseases.
They also contribute to the fight against antimicrobial resistance by reducing the need for the use of antibiotics in animals.
However, there are recognised gaps in the availability of vaccines against certain diseases, and evidence that both the data requirements and time-to-market have increased within the EU over the last 15 years.
The EMA say the situation is serious for minor species diseases, those which are rare in major species (such as Q fever in cattle), or diseases that affect minor species like goats or ducks.
The plan implements the recommendation from a workshop organised by the EMA and HMA in March 2015.
Participants at this workshop reviewed the requirements for the authorisation of veterinary vaccines within the EU and examined the reasons for the current lack of certain veterinary vaccines.
Companies marketing medicines for small pets exempt from authorisation must submit their annual return to the Veterinary Medicines Directorate (VMD) by 30 November 2026.
