New EU rules for safe and high-quality medicines for animals become effective
Today, the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) becomes applicable. It contains new measures for stimulating innovation and increasing the availability and access to safe and high-quality veterinary medicines for veterinarians, farmers and pet owners to treat and prevent animal diseases and also supports the European Union (EU) action against antimicrobial resistance (AMR).
’’Today marks the start of a new era in the regulation of medicines for animals,’’ said EMA’s Executive Director Emer Cooke. ’’The tools and systems introduced by the new Regulation will ensure wider access to information on medicines for animals to all stakeholders, and will also provide for an enhanced monitoring of suspected side effects. Importantly, prudent and responsible use of antimicrobials in animals is now embedded in the Regulation and will help us fight against antimicrobial resistance.’’
The new rules put in place a range of measures to limit the development of AMR, while ensuring that necessary treatments remain available for animals and people, a true ‘One Health’ approach. The new provisions foresee that preventive antimicrobial use is permitted only in exceptional circumstances and introduce the possibility to restrict or prohibit the use of important antimicrobials in animals, reserving the most important of them for treatment of certain conditions in humans.
The new Regulation contains measures that will simplify regulatory processes, striving to reduce administrative burden for current marketing authorisation holders and developers of new and innovative veterinary medicines to further encourage medicine innovation and development.
For the first time, information about all veterinary medicines authorised in the EU and European Economic Area (EEA) countries will be available on a central website.
Another key novelty is that from now on veterinary prescriptions will be valid throughout the EU. Furthermore, a common logo was established to facilitate identification of online retailers, which are authorised to sell veterinary medicines that require prescription. Online retailers will have to display the common logo on their website and link it to the relevant EU/EEA national authority website. These authorities will list all registered online medicine retailers in their country on their websites.
During the lead-up to the entering into application of the Regulation, EMA has revised its procedures and regulatory and scientific guidance documents. The Agency has also led, in collaboration with the Member States and stakeholders, the development and implementation of the IT systems required by the Regulation:
- Union Product Database
- Union Pharmacovigilance Database
- Manufacturing and Wholesale Distribution Database
’’Today marks the launch of the IT systems that will support the simplification of many regulatory procedures. A critical success factor in the timely delivery of this complex programme was the consistent collaboration with the European Commission, the regulatory network and our stakeholders. The Agency is committed to continue investing in the development of the systems to support efficient functioning of processes, which stem from the new regulatory framework,’’ said Ivo Claassen, Head of EMA’s Veterinary Medicines Division.
The Union Product Database gathers information on all veterinary medicines authorised in EU/EEA countries and will enable some post-authorisation procedures. The system has been set up and will be maintained by EMA in collaboration with the Member States and the European Commission. While EMA and the regulatory network are finalising the upload of product data, activities to improve the data quality have also been initiated.
The Veterinary Medicines information website will provide public access to the data held in the Union Product Database. It is the first website that provides details on all veterinary medicines authorised in the EU and EEA. The website will enable 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. At the same time, by providing a single source of up-to-date information on the availability of veterinary medicines in the EU it will support a better functioning of the single market.
A collection of info-cards presents how different groups of stakeholders (veterinarians, pet owners, farmers) will benefit from the new Veterinary Medicines information website.
The Union Pharmacovigilance Database is launched as an enhanced and upgraded EudraVigilance Veterinary (EVVet3) system for the exchange and processing of suspected adverse reaction reports related to veterinary medicines authorised in the EEA. EVVet3 is supplemented by an upgraded analytics tool and new functionality to support pharmacovigilance monitoring activities. Integrating all these components, the Union Pharmacovigilance Database is the key tool for the continuous monitoring of the safety of veterinary medicines after they are authorised.
The Manufacturing and Wholesale Distribution Database includes information on the granting, suspension or revocation by competent authorities of any manufacturing authorisation, wholesale distribution authorisation, certificates of good manufacturing practice and registration of manufacturers, importers and distributors of active substances for both veterinary and human domains. The system launched today is an enhanced and upgraded version of EudraGMDP, the EU database of manufacturing authorisations and certificates of good manufacturing practice, with changes affecting both the veterinary and the human domains.
More information on these databases can be found on the Veterinary Medicinal Products Regulation page.
Regulation (EU) 2019/5 amended the EU pharmaceutical legal framework set out by Regulation (EU) 726/2004. The new provisions set out in Regulation (EU) 2019/6, which created a legal framework specific to veterinary products, apply from 28 January 2022, and effectively replace Directive 2001/82/EC. The latest consolidated version of Regulation (EU) 726/2004 is available.
*A correction was made to the last paragraph on 28 January 2022 to adequately reflect the changes in the Regulation.