Authorisation, import and manufacture of veterinary medicines
Regulation (EU) 2019/6 on veterinary medicinal products and repealing Directive 2001/82/EC
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.
Application & Background
It applies from 28 January 2022.
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).
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)
Veterinary medicines — good manufacturing practice
Commission Directive 91/412/EEC — good manufacturing practice for veterinary medicines
It sets out the principles and guidelines of good manufacturing practice for medicines for animal use.
National authorities must organise regular inspections to ensure manufacturers comply with the principles and guidelines set out in the legislation.
ensure that their activities are properly authorised and respect good manufacturing practice;
regularly review their manufacturing methods in the light of scientific and technical progress;
establish and implement an effective pharmaceutical quality assurance system, involving management and staff;
have enough competent and qualified staff to ensure quality standards are met;
define the duties of the managerial and supervisory staff and provide them with appropriate training;
establish and maintain documentation records, a quality control system under a suitably qualified person and hygiene programmes;
conduct frequent inspections of their operations and take any necessary corrective measures;
implement a system to respond to, and investigate, complaints and have measures in place to promptly recall any medicines if necessary, while informing the competent authorities of their action.
The premises and equipment used must be located, designed, constructed, adapted and maintained to suit their intended purpose, minimise the risk of error and allow effective cleaning and maintenance.
The quality control system includes access to quality control laboratories and must retain samples of each batch of medicines for at least a year after their expiry date.
Any work contracted out must be authorised by a written contract setting out the responsibilities of both parties in complying with good manufacturing practice.
Importers must ensure that the imported products have been manufactured according to standards that are at least equivalent to those in the EU.
Application & Background
It has applied since 23 July 1991. EU countries had to incorporate it into national law by 23 July 1993.
For more information, see:
‘Quality of medicines and Good Manufacturing Practices (GMP)’ on the European Commission’s website
‘Good-manufacturing-practice and good-distribution-practice compliance’ on the European Medicines Agency’s website
Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products (OJ L 228, 17.8.1991, pp. 70–73)
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, pp. 1–33).
Subsequent amendments to Regulation (EC) No 726/2004 have been incorporated into the basic text. This consolidated version is of documentary value only.
Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products (OJ L 136, 30.4.2004, pp. 58–84)
Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, pp. 1–66). See consolidated version.
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