Since 28 January 2022, Regulation (EU) 2019/6, the EU regulation on veterinary medicines, is applicable in the EU.
Regulation (EU) 2019/6 is a cornerstone to support achieving the objectives set in the European One Health Action Plan on antimicrobial resistance (AMR), consolidating the EU’s leading role on the global stage in actions against AMR.
The regulation is central to achieving the aspirational EU target of reducing overall EU sales of antimicrobials for farmed animals and in aquaculture by 50% by 2030, through very concrete measures such as restricting the preventive use of antimicrobials in groups of animals.
Adopted in 2019, Regulation (EU) 2019/6 on veterinary medicines entered into application on 28 January 2022.
The main objectives of the legislation are to:
- provide for a modern, innovative and fit-for-purpose legal framework on veterinary medicines,
- give incentives to stimulate innovation for veterinary medicines and increase their availability,
- strengthen the EU action to fight antimicrobial resistance.
In particular, the Regulation provides for a wide range of complementary measures to fight antimicrobial resistance (AMR) and to promote prudent use of antimicrobials in animals, such as:
- a ban on the preventive use of antimicrobials in groups of animals,
- restrictions on metaphylactic use of antimicrobials (control treatment preventing a further spread of infection) in animals,
- a ban on the use of antimicrobials for promoting growth and increasing yield (supplementing the prohibition on using antibiotics as feed additives, effective from 1 January 2006),
- the possibility to reserve certain antimicrobials for treatment of infections in humans,
- the obligation for Member States to collect data on the sales and use of antimicrobials in animals.
The EU regulatory framework for veterinary medicines needed to be adapted to scientific progress and to current market conditions and economic realities, while continuing to ensure a high level of protection of animal health and welfare, safeguarding public health, and protecting the environment.
To ensure efficient implementation of the EU regulation on veterinary medicines, supplementary legislation supporting this regulation is required. The Commission has adopted and published a number of delegated and implementing regulations.
The rules set in the EU regulation on veterinary medicines will contribute significantly to reducing the use of antimicrobials in animals, through the concrete measures promoting their prudent use. These rules will be instrumental to achieve the aspirational EU target of reducing by 50% the overall EU sales of antimicrobials for farmed animals and in aquaculture by 2030. This ambitious—yet realistic—objective aims to curb AMR, while ensuring adequate treatment of sick animals where necessary.
The obligation for Member States to collect data on sales of antimicrobial veterinary medicines and on use of antimicrobials in animals, set out in the regulation, will play an essential role in monitoring the actual consumption of antimicrobials in the EU.
It is important to keep in mind that initiatives allowing the prevention of infections, such as biosecurity (e.g. measures designed to protect farms from the entry and spread of diseases), hygiene, vaccination and good animal husbandry can help achieve this reduction.
The revised EU regulation on veterinary medicines will bring benefits to animals, farmers, pet owners, veterinarians, pharmaceutical companies and other businesses by stimulating innovation for veterinary medicines, streamlining processes and procedures, ensuring availability of veterinary medicines, including for limited markets (less common animal species or rare diseases) and also containing rules that contribute to reducing antimicrobial resistance.
Every citizen will gain from this regulation, especially through the measures to fight antimicrobial resistance, as there are clear links between human health, animal health and the environment.
For animals, the benefit will come from the increased number of medicines available to treat them, as well as from an appropriate use of antimicrobial medicines.
Veterinarians, farmers and pet owners should have better access to veterinary medicines to treat animals.
Human health is expected to benefit from the regulation, notably through rules aiming at keeping antimicrobials (including antibiotics) effective to treat infectious diseases in humans.
Pharmaceutical companies will benefit for example from a wider use of the centralised authorisation procedure and a reduction of administrative burden, as well as from measures to stimulate the development of new veterinary medicines, including innovative vaccines, and of new veterinary medicines for rare diseases and for less common species.
Other businesses, such as suppliers of veterinary medicines, will benefit from improved competition, as well as improved circulation of veterinary medicines across the EU. The strengthened functioning of the internal market, combined with enhanced innovation, will contribute to creating more growth and jobs in the EU.
Operators in non-EU countries wishing to export to the EU animals and products of animal origin intended for human consumption must respect the EU rules not to use antimicrobials for growth promotion or yield increase or those antimicrobials reserved in the EU for the treatment of certain infections in humans (Commission Implementing Regulation (EU) 2022/1255).
The EU regulation on veterinary medicines contributes to the fight against antimicrobial resistance (AMR) by adopting a coherent approach and ensuring that animals and products of animal origin intended for human consumption available in the EU market have been treated with antimicrobials in a prudent way, regardless of their origin.
More information on the specific rules is available in the detailed rules supplementing Article 118.
Yes. Promotion of availability of veterinary medicines by stimulating innovation and competitiveness is a key component of the regulation.
A simplified assessment procedure and a data protection period for innovative development of veterinary medicinal products (for example for new indications or new routes of administration), which may be extended up to 18 years under certain conditions, are now in place.
Such provisions intend to stimulate the development of new veterinary medicines, including innovative vaccines, as well as the development of new veterinary medicines for rare diseases and for less common species, such as bees.
Another example is the setting of a clear definition and of adequate rules for biological and novel therapy veterinary medicines, which will incentivise the development of new veterinary medicines in those areas.
Finally, opening up the centralised authorisation procedure to all veterinary medicines and allowing for marketing authorisations under exceptional circumstances is expected to broaden the spectrum of veterinary medicines brought to the market across the EU.
EMA has been playing a key role in the implementation of the EU veterinary medicines regulation. It has provided the Commission with the scientific advice required for the preparation of certain pieces of the supplementary legislation that is key to an efficient implementation of the EU regulation on veterinary medicines. This supplementary legislation consists of a series of implementing and delegated regulations.
Moreover, EMA plays a crucial role in maintaining the Union product database. EMA will continue to further develop the Union product database to support the implementation of the EU regulation on veterinary medicines, in collaboration with the Member States and considering the feedback provided by the users of the database.
Member States have also provided valuable input to the Commission for the preparation of the supplementary legislation and play a crucial role by having appropriate measures in place, and resources earmarked at national level, to support an effective implementation of the EU regulation on veterinary medicines and make its implementation a shared success.