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CONSULTATIONS
 

THE VETERINARY MEDICINES REGULATIONS 2010 - 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 18 June 2010 .

The Veterinary Medicines Regulations (VMR) 2009 came into force on 1 October 2009 . 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 2010 will come into force on 1 December 2010 and will replace the current Veterinary Medicines Regulations 2009 SI No 2009/2297.

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)

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: l.shelley@vmd.defra.gsi.gov.uk by 10 September 2010 , although earlier comments will be welcomed.

Veterinary Medicines Guidance (VMG) Notes

Four of the Guidance Notes have received major revisions:

 

Guidance Note 3 – Veterinary Medicinal Products – Prescription, Distribution Categories and Supply

 

Guidance Note 4 – Marketing Authorisations for Veterinary Medicinal Products – National Variation Procedures

 

Guidance Note 19 – Horse Medicines (Incorporating guidance relating to Horse Passports)

 

Guidance Note 23 – Do you need a Marketing Authorisation? – has been reformatted into the same style as the rest for consistency.

 

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 (7 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)

19

Horse Medicines (incorporating Guidance Relating to Passports)

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
Email  : Telephone +44 (0)1932 336911 :  Fax +44 (0)1932 336618  : Find Us


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