VMR 09

CONSULTATIONS

THE VETERINARY MEDICINES REGULATIONS 2009 - FORMAL PUBLIC CONSULTATION

CD versions of the documents can be provided, to request a CD please use the contact details below.

This formal consultation package was published on 5 May 2009.

The Veterinary Medicines Regulations (VMR) 2008 came into force on 1 October 2008. It is intended for us to revoke and remake them each year. This provides the opportunity to review and amend any of the provisions that need to be changed and to make any necessary inflationary increase to the fees.

It is intended that the VMR 2009 will come into force on 1 October 2009 and will replace the current Veterinary Medicines Regulations 2008 SI No 2008/2297.

Consultees are invited to consider the amendments and the consultation package includes:

The consultation letter which has been sent to interested parties
A MS Word version of the response form
A clean draft of the amended Regulations
A draft of the amended Regulations with tracked changes
A partial Impact Assessment for the changes proposed to the legislation
Veterinary Medicines Guidance (VMG) Notes (see below)
A Variations Information Sheet

As well as comments on specific aspects of the proposals, we would welcome details of any anticipated increase or reduction in costs, benefits or burdens associated with the proposed changes to the Regulations. We would also welcome proposals for additional guidance if it is felt to be needed on any particular aspect.

Comments should be sent to Lorna Shelley (e-mail: rvmtemp@vmd.defra.gsi.gov.uk ) by 28 July 2009, although earlier comments will be welcomed.

Veterinary Medicines Guidance (VMG) Notes

Any of the below notes can be opened by clicking on the relevant link.

If however you would like all of the VMG notes they are available to download in a single .rar file (4.6 Mb). To download right click here and choose 'save target as'. This may take some time depending on your Internet connection speed. To learn more about .rar files please click here (this will take you to an external site).

1	An Introduction to Marketing Controls on Veterinary Medicines
2	Marketing Authorisations for Veterinary Medicinal Products Applications and Renewals
3	Marketing Authorisations for Veterinary Medicinal Products – Prescription, Distribution Categories and supply
4	Marketing Authorisations For Veterinary Medicinal Products - National (IA/IB/II) Variation Procedures
5	Marketing Authorisation for Veterinary Medicinal Products - Exceptional Marketing Authorisations
6	Marketing Authorisations for Veterinary Medicinal Products - Parallel Imports
7	Import Certificate Schemes
8	Animal Test Certificates
9	Veterinary Homoeopathic Remedies
10	Wholesale Dealer’s Authorisations for Veterinary Medicines
11	Marketing Authorisations for Veterinary Medicinal Products – Appeals Procedures
12	Improvement and Seizure Notices
13	Marketing Authorisations for Veterinary Medicinal Products – Supplementary Guidance on Pharmacovigilance
14	Marketing Authorisation Exemption Scheme for Pet Animal Medicines
15	Guidance on the use of the Cascade
16	Record-Keeping Requirements for Veterinary Medicinal Products
17	Authorisations for Manufacturers - Autogenous Vaccines, Non-food Animal Blood Banks, Equine Stem Cell Centres and products for administration under the ‘cascade’
18	Marketing Authorisations for Veterinary Medicinal Products – Requirements for Product Literature and Summary of the Product Characteristics (SPCs) (263 Kb)
19	Guidance removed as no longer applicable
20	Veterinary Medicinal Products - Qualified Persons
21	Medicated Feedingstuffs Prescriptions
22	Medicated Feedingstuffs and Specified Feed Additives
23	Veterinary Medicines – Do you need a Marketing Authorisation?
24	Specific Batch Control Scheme (Pharmaceutical Products Only)
25	Export Certificates Scheme
26	Marketing Authorisations - Legislative Updates to SPCs and Product Literature Please Note: This is an archive document retained for reference purposes
27	Incorporating Veterinary Medicines into Fish Feed
28	Practice Registration and Inspections
29	Controlled Drugs
30	Guidance for Manufacturers - GMP Requirements

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Veterinary Medicines Directorate
Woodham Lane, New Haw, Addlestone, Surrey KT15 3LS
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