New Veterinary Medicines Law Comes into Force on 1 October17 September 2013
UK - The Veterinary Medicines Regulations 2013 (Statutory Instrument 2033; SI 2033; VMR) will come 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, according to the Veterinary Medicines Directorate (VMD).
The VMR also implements 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:
- 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.
- Rebalancing of fees for manufacturers and wholesale dealers.
- An increased charge for inspections of veterinary practice premises 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.
The VMR are available electronically on the legislation.gov.uk web site following the links:
- SI 2013/2033 - Web version (HTML)
- SI 2013/2033 - Print version (pdf 513kb)
- SI 2013/2033 - Explanatory Memorandum
In addition, the VMD has made available a document in which the changes that have been made to the legislation have been highlighted [click here].ThePoultrySite News Desk