Information for you
On this page, you will find information on the Agency’s activities, including news and events, that are most relevant to Animal health professionals and users of veterinary medicines such as pet owners.
You can contribute to the Agency’s work by responding to public consultations.
Learn more about the European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) and its role regarding medicines for veterinary use.
Consultation on revised guidelines on data requirements for minor use, minor species (MUMS)/limited market
The revision updates the guidance in line with the experience gained over the last 10 years in setting appropriate data requirements for the quality, safety and efficacy for pharmaceutical products, and separately for immunologicals. The consultation runs for six months from January 2016.
Veterinary medicines highlights 2015
EMA has released an overview of its key recommendations in 2015 on the authorisation of new veterinary medicines and the safety monitoring of authorised medicines. EMA recommended 14 veterinary medicines for marketing authorisation, half of which contain a new active substance.
Vaccines against epizootic diseases
The EMA Management Board agreed financial incentives to support the availability of veterinary vaccines against certain epizootic diseases, such as bluetongue and foot and mouth disease, by waiving maintenance fees in the absence of sales and when specified criteria are met. See page 43 of the explanatory note on fees payable to the Agency. This initiative supports the principle of “prevention is better than cure” outlined in the European Commission’s Animal Health Strategy (2007-2013).
Finding Maximum Residue Limits (MRLs)
A maximum residue limit (MRL) is the maximum acceptable concentration of an active substance that may be found in a food product obtained from an animal that has received a veterinary medicine. You can search or browse by substance for information on specific MRLs.
The Agency works with its partners to raise awareness of antimicrobial resistance in the European Union.
News for animal health professionals
European expert group proposes reduction of use in animals of last resort antibiotic colistin to manage risk of resistance
Updated advice is released for public consultation ... Read more
CVMP opinions on veterinary medicinal products ... Read more
EMA publishes report on the first ten years of its SME initiative ... Read more
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Events of interest
The CVMP will be holding an interested parties meeting as part of regular stakeholder liaison. Topics for discussion this year will include MUMS and JEG 3R (replacement, reduction and refinement), availability of veterinary medicines antimicrobials resistance and discussion on operational excellence. ... Read more
17/03/2016 - 18/03/2016
The info day covers the latest developments in the scientific review, regulation and marketing authorisation procedure. It is an opportunity for professionals to get first-hand information on current developments in the veterinary regulatory scene. Registration open. ... Read more
The annual European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) stakeholders annual meeting 2016
The annual European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) meeting for stakeholders held on 2 March 2016 was organised by the European Medicines Agency to inform European Union Member States, stakeholders and observers on latest activities related to collection of data of veterinary antimicrobials and on the draft ESVAC strategy 2016-2020 and also to share information on activities for the containment of antimicrobial resistance. ... Read more
The CVMP will be holding an interested parties meeting as part of regular stakeholder liaison. Subjects for discussion will include pharmacovigilance, environmental risk assessment, SPC harmonisation and measures taken to promote the 3 Rs (replacement, reduction and refinement). Registration by invitation only. ... Read more
Joint European Medicines Agency / Heads of Medicines Agencies workshop on requirements for the authorisation of veterinary vaccines in the European Union
The workshop brought together experts from national competent authorities and industry to debate how to improve the availability of veterinary vaccines, a topic of high priority for both European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) for many years. The meeting concluded that the reasons why more veterinary vaccines are not available in the European Union (EU) are complex and relate to the approach to management of risk and uncertainty, technical requirements and administrative procedures. A meeting report will be published on the EMA website that will form the basis for a joint EMA/HMA action plan involving industry and other experts in its implementation. The aim will be to develop proposals to enhance availability of veterinary vaccines whilst maintaining the current high level of protection of animal and public health and the environment. ... Read more
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