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 (VMR). The VMR are revoked and replaced on a regular 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 Denise Burge (01932 338312 or email@example.com).
Veterinary Medicines Regulations 2013 SI 2033 (VMR) and Veterinary Medicines Guidance Notes (VMGN):
The VMR 2013 (SI 2033) came into force on 1 October 2013.
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 a summary of changes they introduce this time are:
- Prohibit the advertising of antibiotic POM-V medicines to professional keepers of animals and POM-VPS medicines to owners or keepers of horses.
- Amend the provisions relating to importation and possession of unauthorised veterinary medicines.
- Amend Regulation 35 (1) (g) to permit an inspector to seize anything they believe (with reasonable grounds) to be a veterinary medicine.
- Introduce a clause within Schedule 3 to allow the removal of a veterinary practice premise from the register if the practice is not up to the standards.
- Clarification of fees for applications for Marketing Authorisations relating to "biosimilar" products.
- Introduce a fee for the renewal of a registration of a homeopathic remedy.
- Amendment of category descriptions for extensions to Marketing Authorisations.
- Simplify the fees for appeals to the Veterinary Products Committee.
- Removal of the fee for additional member states on application for a Marketing Authorisation relating to a parallel import.
- Reduction to fees for Decentralised applications for Marketing Authorisations where the UK is Concerned Member State or for recognition of a product authorised in another member state. (This formalises existing fee reductions which have been in place since 1 April 2012).
- Rebalancing of fees for manufacturers and wholesale dealers.
- An increased charge for inspections of veterinary practice premises as a move to achieve full cost recovery of this work.
- Changes to fee structure for inspections of manufacturers and distributors of feedingstuffs.
- Reduction in fee for specific batch control applications relating to subsequent batches of product.
- Increase for the application and subsequent annual fee for fees relating to manufacturers and distributors of feedingstuffs in Northern Ireland.
- Changes to the fees applied by the Royal College of Veterinary Surgeons (RCVS) for the registration of Veterinary Practice Premises.
Veterinary Medicines (Amendment) Regulations 2014 (VMR) (SI 599)
The following minor errors have been identified and corrected in the Veterinary Medicines (Amendment) Regulations 2014 which came into force on 14 April 2014:
- Amendment to wording in para 20 which was ambiguous relating to the prescribing of medicated feedingstuffs,
- to correct references in para 29 for offences regarding importing/re-exporting of premixes or feedingstuffs, and
- correct an inadvertent removal of an offence relating to the requirement that for medicated feedingstuffs, a vet may only prescribe a veterinary medicinal product which is authorised for incorporation into feedingstuffs (para 31).
- To correct the removal of the word "non" before "food-producing" in the table of fees at para 17,
- to correct the fee for a wholesale dealer's import certificate (para 50) from £1,320 to £760, and
- to amend the method of calculation for the fee for specific batch control applications which is expressed incorrectly in the VMR 2013 (para 51).
The VMR 2013 and the Veterinary Medicines (Amendment) Regulations 2014 are available electronically on the legislation.gov.uk website following the links:
- SI 2013/2033 - Web version (HTML)
- SI 2013/2033 - Print version (pdf 513kb)
- SI 2013/2033 - Explanatory Memorandum
- Track Change Version (680kb)
- SI 2014/599 - Web version (HTML)
Hard copies may be purchased from the Stationery Office (TSO) at www.tshshop.co.uk.
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.