The veterinary regulatory framework and its procedures
Veterinary medicines have their own regulatory framework, with different authorisation routes and competent authorities according to the product and country.
Regulation (EU) 2019/6
Regulation (EU) 2019/6 on veterinary medicinal products became applicable on 28 January 2022. It repealed Directive 2001/82/EC and amended the veterinary-authorisation and supervision provisions of Regulation (EC) No 726/2004. It was the first medicines regulation specifically addressing veterinary products, while the equivalent human-medicines Directive 2001/83/EC remained in place in 2020.
The regulation aims to improve medicine availability, reduce administrative burden, encourage innovation, combat antimicrobial resistance and establish a modern legal framework. It seeks to accommodate scientific progress, market conditions and economic realities while protecting animal health, animal welfare, the environment and public health. The veterinary sector has smaller commercial potential than the human sector while serving a diversity of animal species and therapeutic needs.
Changes welcomed by industry in 2020 included removal of marketing-authorisation renewals, making authorisations valid for an unlimited period, and opening the centralised procedure to applications for products not previously authorised in the EU through national, mutual-recognition or decentralised procedures. The 2020 industry account cautioned that harmonising summaries of product characteristics might increase workload.
At implementation in January 2022, veterinary prescriptions became valid throughout the EU, and a common logo identified authorised online veterinary-medicine retailers. Retailers were required to display the logo with a link to their EU/EEA national authority's website, where registered retailers would be listed.
The European Medicines Agency (EMA) revised its procedures and regulatory and scientific guidance and led the development of three required IT systems with Member States and stakeholders.
- Union Product Database
- Union Pharmacovigilance Database
- Manufacturing and Wholesale Distribution Database
The Union Product Database gathers information on all veterinary medicines authorised in EU/EEA countries and was designed to enable some post-authorisation procedures, with EMA responsible for its maintenance alongside Member States and the European Commission. Its public Veterinary Medicines information website was intended to show the countries where a medicine is available, help identify treatment alternatives and support the single market through a common source of availability information. At launch, product-data upload was still being finalised and data-quality improvement had begun. The Manufacturing and Wholesale Distribution Database was launched as an upgraded EudraGMDP covering both human and veterinary medicines, recording authorisations, suspensions and revocations, good-manufacturing-practice certificates, and registrations of active-substance manufacturers, importers and distributors.
The regulation required authorities to establish and maintain the Union Product Database. By 2019 EMA also had a policy to address shortages of medicines for minor animal species and uncommon diseases in major species, analogous to orphan designation.
Development of the framework
On 10 September 2014 the European Commission proposed a revision of the veterinary-medicines framework with four aims.
- Simplify the regulatory environment and reduce administrative burden through streamlined marketing-authorisation procedures and simpler pharmacovigilance rules.
- Stimulate new medicines, including those for minor uses and minor species, through special rules for areas such as apiculture and aquaculture and better rewards for investment in innovative medicines.
- Facilitate circulation of veterinary medicines across the EU through streamlined procedures and clear internet-retailing rules.
- Combat antimicrobial resistance, including restrictions on animal use of certain antimicrobials reserved for treating human infections.
A parallel proposal sought to ensure that medicated feed was produced only by approved manufacturers using authorised veterinary medicines. The proposals entered the Parliament and Council's co-decision process.
After four years of negotiation, the Parliament and Council adopted Regulation (EU) 2019/6 in December 2018, and it was published on 7 January 2019. Regulation (EU) 2019/4 on medicated feed also entered into force in January 2019 and repealed Directive 90/167/EEC. Preparation for the veterinary-medicines regulation required 28 delegated and implementing acts.
In 2019 EMA provided scientific and technical recommendations for these acts at the Commission's request, with its Committee for Medicinal Products for Veterinary Use (CVMP) adopting recommendations before they were sent. Experts from EMA and Member States prepared them, consulting other EU bodies where necessary; topics included antimicrobial sales-and-use data and the Union Product Database. The new data requirements were intended to complement existing collection of antibiotic-sales data in EEA states and Switzerland. EMA launched an implementation-progress webpage on 23 September 2019.
Competent authorities
A 2014 account distinguished authorities by country and product: the veterinary authority could be the human-medicines regulator or a separate body. EMA had human and veterinary departments, with the veterinary department covering pharmaceuticals and immunologicals. In Germany, the Federal Office of Consumer Protection and Food Safety regulated veterinary pharmaceuticals, while the Paul Ehrlich Institute regulated veterinary and human immunological products; the veterinary regulator consulted the Federal Office for the Environment on environmental safety. Some EU Member States assigned topical antiparasitic veterinary products to agricultural agencies and other veterinary medicines to human-medicines or specifically veterinary authorities.
A 2019 account distinguished EMA requirements for marketing veterinary pharmaceuticals from European Food Safety Authority requirements for feed additives.
Authorisation routes under the directive
In the 2014 framework, veterinary registration procedures broadly matched those for human medicines. Small companies concentrating on one national market sometimes chose a national application and licence, whereas larger companies generally used European procedures. The European procedures were mutual recognition, decentralised and centralised authorisation.
- Mutual recognition: A holder extending an existing national licence to other EU countries had to use this procedure, nominating a Reference Member State to assess the dossier, with Concerned Member States accepting that assessment.
- Decentralised: Companies generally chose this route for a new product in more than one European country, using Reference and Concerned Member States but applying simultaneously to all participating countries.
- Centralised: Applications went to EMA; certain biotechnology products fell within mandatory scope and products with new active substances within optional scope, with the Commission granting an authorisation valid throughout the Community market.
Generic pharmaceuticals, biosimilar immunological products and bibliographic applications based largely on literature references could be registered.
Legislation and guidance sources
New veterinary regulatory writers need an overview of the regulatory structure, legislation and guidance. In 2014 the main information sources were divided as follows.
| Source | Coverage in 2014 |
|---|---|
| Eudralex Volume 5 | Directive 2001/82/EC as amended, covering veterinary marketing-authorisation applications, on the Commission's website in all official European languages. |
| Eudralex Volume 6 | Registration procedures and dossier presentation and content. |
| Eudralex Volume 7, EMA and VICH websites | CVMP scientific guidelines had moved from Volume 7 to EMA's website, which also covered International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) guidelines. |
| Eudralex Volume 8 | The legal framework for maximum residue limits for veterinary medicines. |
| Eudralex Volume 9; IFAH-Europe | Pharmacovigilance guidelines; the International Federation for Animal Health Europe, representing manufacturers of veterinary medicines, vaccines and other animal-health products. |
EMA's veterinary scientific guidance includes quality, safety and residues, efficacy, immunological products and novel therapies.
Authorisation recommendations in 2024 and 2025
EMA recommended 25 veterinary medicines for marketing authorisation in 2024, its highest annual number at that point. Two contained active substances not previously authorised for veterinary use in the EU, and 14 were vaccines, seven developed through biotechnology. Thirteen were for food-producing animals such as chickens, pigs and cattle, and 11 for companion animals such as dogs and cats.
In 2025 EMA recommended 30 veterinary medicines, setting a record for the second consecutive year. EMA's account interpreted this as sustained development interest and a positive effect of the regulation on innovation. Of the 30, 16 were vaccines, including seven approved under exceptional circumstances for animal-health emergencies; five vaccines used biotechnology. The uses of 11 existing products were expanded to new species or indications, offering further treatment opportunities.