Implementing the Veterinary Medicinal Products Regulation

On 28 January 2022, the Veterinary Medicinal Products Regulation became applicable, bringing in a new era in the regulation of medicines for animals. The new legislation aims to reduce administrative burden and introduce better incentives for developers to stimulate innovation and increase the access to safe and high-quality medicines for veterinarians, farmers and pet owners to treat and prevent animal diseases. It also introduces new rules for the prudent and responsible use of antimicrobials in animals to help fight antimicrobial resistance (AMR) in the EU.

By the time the new Regulation became applicable, EMA had revised its procedures and key regulatory and scientific guidance documents to reflect these changes.

Commissioning of three IT systems to manage safe and high-quality medicines for animals 

The new Regulation is underpinned by three IT systems, developed by EMA in close collaboration with Member States and stakeholders, that enable the simplification of processes and ensure wider access to information on medicines for animals for all stakeholders: the Union Product Database (UPD), the Union Pharmacovigilance Database (EVV), and the Manufacturing and Wholesale Distribution Database (MWD). These systems went live on the day the Regulation became applicable.
 

A critical success factor in the timely delivery of the IT systems which stem from the new Regulation was the consistent collaboration with the European Commission, the regulatory network and our stakeholders.

IT development for the Collection of Antimicrobials Sales and Use Data (ASU) project started in January 2022. Over the following months, ASU project activities progressed as planned, with the aim that the first data will be submitted to the system in 2024. 

Throughout the year, EMA provided intense support to facilitate the transition of users from pharmaceutical companies to these new platforms. The Agency established a dedicated support service for users of the new systems and continued to run refresher webinars and change information sessions. In September 2022, EMA established the Veterinary System Improvement Advisory Group (VSIAG) which helps to prioritise new or improved functionalities in the UPD and EVV systems. The group includes representatives from national competent authorities, the pharmaceutical industry, the European Commission, veterinary healthcare professionals and EMA.

Due to the strong collaboration between national competent authorities and EMA throughout the year the uploading of data held in the Member States into the UPD was almost complete by December 2022.

A single source of up-to-date information on all EU veterinary medicines 

A key part of the new Regulation in terms of transparency is the Veterinary Medicines information website, which provides public access to the UPD data. It is the first central multilingual website that gives details on all veterinary medicines authorised in the EU and the EEA. The website enables veterinary healthcare professionals and all interested users to find out in which EU Member States and EEA countries a specific veterinary medicine is available, or to find information that could help identify potential treatment alternatives.