Veterinary Medicines Regulations

The Veterinary Medicinal Products Directive 2001/82/EC (as amended) sets out the controls on the manufacture, authorisation, marketing, distribution and post-authorisation surveillance of veterinary medicines applicable in all European Member States. The Directive provides the basis for the UK controls on veterinary medicines, which are set out nationally in the Veterinary Medicines Regulation. The Regulations are revoked and replaced on an annual basis after consultation with interested groups to ensure that they are up-to-date and fit for purpose.

For more information on the Veterinary Medicines Regulations please contact Lea Reynolds (01932 338321 or l.reynolds@vmd.defra.gsi.gov.uk).

Veterinary Medicines Regulations 2011 SI 2159 (VMR) and Veterinary Medicines Guidance Notes (VMGN):

The Veterinary Medicines Regulations 2011 (SI 2159) (VMR) came into force on 1 October 2011.

The VMR first came into force in October 2005 to implement Directive 2001/82 and consolidate all the controls on veterinary medicines that were previously part of the Medicines Act 1968 and over 50 amending Statutory Instruments. The VMR also implement EU legislation relating to medicated feeds, and some specified feed additives used in feedingstuffs.

The VMR are regularly updated and some of the key changes they introduce this time are:

• a waiver for fees for variations to marketing authorisations seeking to remove or reduce animal tests;
• simplification of the procedure for dealing with variations to national marketing authorisations;
• a revision of the exemptions concerning animals kept on domestic premises, to remove the ceiling on weight of medicated feeding stuff that can be manufactured from premixtures;
• a derogation allowing veterinary surgeons and pharmacists to supply premixtures and medicated feed intended for domestic use without the need to be approved as a distributor;
• a procedure and a fee for applications for advice as to whether or not a product requires a marketing authorisation.

The VMR are available electronically on the Office of Public Sector Information website following the links:

• SI 2011/2159 - Web version (HTML)
• SI 2011/2159 - Print version (pdf 479kb)
• SI 2011/2159 - Explanatory Memorandum

Hard copies may be purchased from the Stationary Office (TSO).

The Impact Assessment (142 kb) for the VMR provides information on the decision making process.

The Veterinary Medicines Guidance Notes, which accompany the VMR, have also been revised by the VMD to reflect the legislative changes and to comply with the Anderson review on guidance. The Anderson review aimed to improve the regulatory guidance that the government gives to business.

The VMD guidance notes provide professionals working in the veterinary sector with clear information on different aspects of the legislation on veterinary medicines.