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Public Consultation

Open Meeeting held 5 February 2013 to discuss the Veterinary Medicines Regulations 2013

The Veterinary Medicines Regulations 2013 Formal Public Consultation - THIS IS NOW CLOSED

The formal consultation package for the Veterinary Medicines Regulations (VMR) 2013 was published on 7 January 2013.

It is intended that the VMR 2013 will come into force on 1 October 2013 and will replace the current Veterinary Medicines Regulations 2011 SI No 2011/2159.

Interested parties are invited to consider the amendments. As well as comments on specific aspects of the proposals, we should welcome details of any anticipated increase or reduction in costs, benefits or burdens associated with the proposed changes to the Regulations. Please also let us know if there are other topics where guidance would be of help.

Comments should be sent to Lorna Shelley (e-mail: l.shelley@vmd.defra.gsi.gov.uk) by 18 February 2013, although earlier comments will be welcomed.

An Open Meeting will be held on Tuesday 5 February 2013 to present an overview of the consultation responses and provide attendees with an opportunity to raise and discuss any outstanding concerns. Refreshments will be available from 1.30pm. Please contact Lorna Shelley (e-mail l.shelley@vmd.defra.gsi.gov.uk tel: 01932 338320) to book places. Places will be available on a first come first served basis and as the consultation group is quite large please limit you nominations to a maximum of two from your organisations.

The consultation package

Key Changes to the Veterinary Medicines Regulations 2013

  • Change 1: Amendment to the provisions relating to importation and possession of unauthorised veterinary medicines which will allow enforcement action to be taken where necessary.
  • Change 2: Amendment to Regulation 35 (1) (g) to permit an inspector to seize anything they believe (with reasonable grounds) to be a veterinary medicine.
  • Change 3: Introduction of a clause within Schedule 3 to allow the removal of a Veterinary Practice Premise (VPP) from the register if the practice is not up to the expected standards.
  • Change 4: Clarification of fees for applications for Marketing Authorisations relating to certain biological products.
  • Change 5: Introduction of a fee for the renewal of a registration of a homeopathic remedy.
  • Change 6: Amendment of category descriptions for extensions to Marketing Authorisations to align them with EU legislation.
  • Change 7: Simplification of the fees for appeals to the Veterinary Products Committee.
  • Change 8: Removal of the fee for additional member states on applications for a Marketing Authorisation relating to a Parallel Import.
  • Change 9: Reduction to fees for decentralised applications for Marketing Authorisations where the UK is the Concerned Member State or for recognition of a product authorised in another member state.
  • Change 10: Rebalancing of fees for manufacturers and wholesale dealers.
  • Change 11: Increase to the charge for inspections of veterinary practice premises (VPP) to achieve full cost recovery for this work.
  • Change 12: Changes to fee structure for inspections of Manufacturers and Distributors of Feedingstuffs and Suitably Qualified Persons (SQP) Premises.
  • Change 13: Increase for the application and subsequent annual fee for fees relating to manufacturers and distributors of feedingstuffs in Northern Ireland.
  • Change 14: Reduction to the fees applied by the Royal College of Veterinary Surgeons for the registration of a VPP.

Detailed information on these changes can be found in the Impact Assessment

Veterinary Medicines Guidance Notes (VMGNs)

Number Title
1 Controls of Veterinary Medicines
3 Guidance for Retailers
4 Controls on Advertising
5 Import Certificate Schemes
8 Wholesale Dealers Authorisation for Veterinary Medicinal Products
10 Guidance on Enforcement
12 Exemptions for Small Pet Animals
15 Manufacturing Authorisations
17 Medicated Feedingstuffs and Specified Feed Additives
20 Controlled Drugs

If you would like all 10 VMG notes they are available to download in a single .rar file (5.35 Mb). To download: right click here and choose 'save target as'. This may take some time depending on your Internet connection speed.

Last Updated: 13 May 2013

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