PUBLISHED BY EMA News 23/09/2019

EMA has launched a new webpage that shows the progress made by the Agency in the implementation of the new Veterinary Medicines Regulation (Regulation (EU) 2019/6), which becomes applicable on 28 January 2022. On this webpage, stakeholders can find all relevant information regarding EMA’s scientific and technical recommendations to the European Commission that will feed into delegated and implementing acts as part of the implementation of the legislation, as well as updates on other activities such as the preparation for implementation progresses. 

The new regulation contains new measures for increasing the availability of veterinary medicines and enhances EU action against antimicrobial resistance, a high priority for the Agency and the European medicines regulatory network. It also aims to reduce administrative burden and encourage medicine innovation and development.

As part of the implementation of the veterinary regulation, the Commission is now preparing legislative acts, for which EMA provides scientific and technical recommendations when requested. 

Some of the topics covered by the Agency’s recommendations are new requirements for the collection of data on the sales and use of antimicrobials in animals, which will complement the work already carried out by EEA states and Switzerland to gather data on sales of antibiotics, or the development of a Union Product Database on veterinary medicines, which will provide information on all veterinary medicines that have been approved, and their availability in EU Member States.

“The new veterinary legislation is an area we prioritised and work has been going on, despite EMA having to operate under business continuity conditions to safeguard core activities related to the evaluation and supervision of veterinary medicines,” says Ivo Claassen, Head of EMA’s Veterinary Medicines Division.

“However, progress might be affected as the Agency will not only need time to rebuild its workforce after the relocation, but may also have to absorb the new activities without a corresponding staffing increase.”

Preparations are being carried out by experts from EMA and the EU Member States, in consultation with other EU bodies, where necessary. EMA’s Committee for Medicinal Products for Veterinary Use (CVMP) adopts the Agency’s scientific recommendations before EMA provides them to the European Commission. A number of recommendations were sent already to the Commission in August.

The relevant documents on the progress of the work on this legislation will be published on the Agency’s website as they become available.

Regulation (EU) 2019/6 repeals Directive 2001/82/EC and amends the provisions of Regulation (EU) 726/2004 relating to the authorisation and supervision of veterinary medicines, which currently governs the centralised marketing authorisation procedure for both human and veterinary medicines. The European Parliament and the European Council adopted Regulation (EU) 2019/6 in December 2018.