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.
Veterinary medicines highlights 2016
EMA has released an overview of its key recommendations in 2016 on the authorisation of new veterinary medicines and the safety monitoring of authorised medicines. EMA recommended 11 veterinary medicines for marketing authorisation.This includes recommendations for 6 new active substances.
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.
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
Task force to establish roadmap and recommendations for use of big data in assessment of medicines ... Read more
CVMP opinions on veterinary medicinal products. ... Read more
Focus on veterinary medicines ... Read more
EMA’s appeals against interim measures are dismissed by Court of Justice ... Read more
- See all News for animal health professionals
Events of interest
16/03/2017 - 17/03/2017
The European Medicines Agency veterinary medicines info day, organised in collaboration with International Federation for Animal Health Europe (IFAH-Europe), provides first-hand information on the latest developments in the scientific review, regulation and marketing authorisation procedure in the field of veterinary medicine regulation. For the first time, this year, European Medicines Agency (EMA) will have dedicated information points on esubmissions, veterinary application submissions and veterinary medicines innovation. ... Read more
Veterinary focus group meeting with stakeholders: revision of the reflection paper on anthelmintic resistance
The focus group meeting aims to facilitate the exchange of views from regulators, industry, research and veterinarians as part of the public consultation process on the revised draft reflection paper on anthelmintic resistance (CVMP/EWP/573536/2013-Rev.1). The Efficacy Working Party of the Committee for Medicinal Products for Veterinary Use (CVMP) revised the first version of the draft reflection paper to take into account comments received during public consultation. The CVMP adopted the revised reflection paper in April 2016 and released it for a second public consultation until 31 July 2016. ... Read more
Stakeholder focus group meeting on availability of lumpy skin disease (LSD) vaccines authorised to European Union (EU) standards
The purpose of the meeting is to review the current scientific knowledge and regulatory environment for the development of lumpy skin disease (LSD) vaccines following incursion of the disease in 2015 and to identify regulatory options to facilitate the development and authorisation of vaccines in accordance with EU standards. The focus group meeting is within the scope of the Heads of Medicines Agencies Network Strategy on availability for veterinary vaccines that aims to increase their availability by ensuring efficient and effective cooperation between all stakeholders. ... Read more
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
- See all Events of interest