Authorisation, import and manufacture of veterinary medicines

SUMMARY OF:

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:

modernise legislation;
stimulate innovation in and increase the availability of VMPs;
strengthen European Union (EU) measures against antimicrobial resistance*.

KEY POINTS

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 (see summary); 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 or combination of substances intended for animals which is used:

to treat or prevent disease;
to restore or modify an animal’s physiological functions, through its effects as a medicine on the animal’s immune system or metabolism (its internal life-maintaining processes);
for medical diagnosis; or
for euthanasia.

A modern innovative legal framework

Among its key measures, the regulation specifies clear and fully harmonised labelling requirements, implements a simpler system for decisions on exceptions and adopts a risk-based approach to pharmacovigilance* and controls.
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 and for importing them.

Promoting increased 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 VMPs based on biological substances produced by the body and for 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 broaden the range of VMPs which can be brought to the entire EU market.

Fighting antimicrobial resistance

The regulation continues and strengthens the 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 use in humans only;
the obligation for EU Member States to collect data on the sale and use of antimicrobials;
various measures aiming towards the careful and responsible use of antimicrobials.

In addition, for their exports into the EU, non-EU countries will have to respect the ban on using antimicrobials for promoting growth and increasing yield and the restrictions on antimicrobials designated as reserved for human use in the EU. This will improve the protection of consumers in the EU against the risk of antimicrobial resistance spread through imports of animals or of products of animal origin.

Transitional rules

Amending Regulation (EU) 2022/839 lays down transitional rules allowing marketing authorisation and registration holders to place VMPs complying with the packaging and labelling requirements of Directive 2001/82/EC or Regulation (EC) No 726/2004 (see summary) on the market until 29 January 2027, even if these products do not comply with the relevant requirements of Regulation (EU) 2019/6. The regulation addresses concerns about the practical application of Article 152(2) of Regulation (EU) 2019/6 and the need to ensure the continued supply of VMPs and to establish legal certainty*.

Repeal

The regulation repeals Directive 2001/82/EC 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 has applied since 28 January 2022.

BACKGROUND

For more information, see:

Veterinary medicines and medicated feed (European Commission)
EU action on antimicrobial resistance (European Commission)
Antimicrobial resistance in veterinary medicine (European Medicines Agency).

KEY TERMS

Antimicrobial resistance. The ability of microorganisms (like bacteria, viruses and some parasites) to stop an antimicrobial (such as an antibiotic, antiviral or antimalarial) from working against them. This resistance means that standard treatments become ineffective and that 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.

Legal certainty. A requirement that laws be drafted in such a way that the persons to whom they apply are able to understand them (they are clear) and to take action knowing the potential consequences of doing so.

MAIN DOCUMENT

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).

Successive amendments to Regulation (EU) 2019/6 have been incorporated in the original text. This consolidated version is of documentary value only.