Authorisation, import and manufacture of veterinary medicines
Regulation (EU) 2019/6 on veterinary medicinal products and repealing Directive 2001/82/EC
WHAT IS THE AIM OF THE REGULATION?
It sets out rules for the sale, manufacture, import, export, supply, distribution, control and use of veterinary medicinal products (VMPs), aiming to:
stimulate innovation in and increase the availability of VMPs;
strengthen the EU’s campaign against antimicrobial resistance*.
The regulation is part of a package of laws on improving animal and human health, which also includes:
Regulation (EU) 2019/4 on the manufacture, placing on the market and use of medicated feed; and
Regulation (EU) 2019/5 on procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.
Veterinary medicinal products
A VMP is any substance intended for animals, which is used:
to treat or prevent disease;
to modify an animal’s physiological functions, through its effects as a drug on the animal’s immune system or metabolism (its internal life-maintaining processes);
for medical diagnosis; or
A modern innovative legal framework
The regulation specifies clear and fully harmonised labelling requirements, adopts a simpler system for decisions on exceptions, and a risk-based approach to pharmacovigilance* and controls among the key measures.
Marketing authorisation must be granted by a competent authority or the European Commission.
Approval is needed for conducting clinical trials, taking care to protect animals used for scientific purposes.
Authorisation is needed for involvement at any stage of the manufacture of VMPs or for importing them.
Promoting availability of VMPs by stimulating innovation and competition
The regulation introduces a simplified assessment procedure and a data protection period, which could extend up to 18 years under certain conditions, designed to stimulate:
- the development of new antimicrobial VMPs;
- new VMPs for rare diseases; and
- VMPs for species such as bees, which are not food-producing animals or pets.
It defines clear rules for organically sourced VMPs and novel therapies which also aim to encourage the development of new VMPs.
In opening up the centralised authorisation procedure and allowing for a range of exceptions, marketing authorisations aim to positively broaden the range of VMPs which can be brought to the market.
Fighting antimicrobial resistance
The regulation continues and strengthens the EU’s fight against EU’s fight against antimicrobial resistance by introducing:
a ban on the preventive use of antibiotics in groups of animals;
a ban on the preventive use of antimicrobials via medicated feed;
restrictions on the use of antimicrobials as a control treatment to prevent a further spread of infection;
a reinforced ban on the use of antimicrobials for promoting growth and increasing yield (in addition to the 2006 prohibition of using antibiotics as growth promoters in feed);
the possibility to reserve certain antimicrobials for humans only;
the obligation for EU countries to collect data on the sale and use of antimicrobials;
science-based maximum limits for cross-contamination of feed with antimicrobials;
various measures aiming towards careful and responsible use of antimicrobials.
In addition, for their exports into the EU, non-EU countries will have to respect the ban on antimicrobials for promoting growth and increasing yield, as well as the restrictions on antimicrobials designated as reserved for human use in the EU. This improves the protection of consumers in the EU against the risk of antimicrobial resistance spread through imports of animals or products of animal origin.
The regulation repeals Directive 2001/82/EC (see summary on EU rules on the authorisation, import and production of veterinary medicines) with effect from 27 January 2022.
FROM WHEN DOES THE REGULATION APPLY?
It applies from 28 January 2022.
For more information, see:
Antimicrobial resistance: the ability of a microorganism (like bacteria, viruses, and some parasites) to stop an antimicrobial (such as antibiotics, antivirals and antimalarials) from working against it. Resistance means that standard treatments become ineffective, infections persist and could spread to others.
Pharmacovigilance: the science and activities relating to the detection, assessment, understanding and prevention of suspected adverse events or any other problem related to a medicinal product.
Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, pp. 43-167)
Regulation (EU) 2019/5 of the European Parliament and of the Council of 11 December 2018 amending Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, Regulation (EC) No 1901/2006 on medicinal products for paediatric use and Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ L 4, 7.1.2019, pp. 24-42)
Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC (OJ L 4, 7.1.2019, pp. 1-23)
Communication from the Commission to the Council and the European Parliament — A European One Health Action Plan against Antimicrobial Resistance (COM(2017) 339 final, 29.6.2017)
Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, pp. 33-79)
last update 27.02.2019