Guidance

Apply to register or renew a Veterinary Homeopathic Remedy (VHR)

Guidance on applying to register or renew a Veterinary Homeopathic Remedy

How to apply

You may submit your application electronically or in hard-copy. Refer to the Submission of an application for an animal medicine licence page.

Application forms

Data requirements

The data and documents required in support of an application for a new registration are annexed to the application form.

All data should be submitted in 2 separate volumes.

Volume 1:

  • ManA number
  • a copy of the registration or authorisation by other member states
  • a copy of any registration granted for the remedy under the equivalent human registration scheme
  • proposed product literature

Volume 2:

  • production and control of homeopathic stocks
  • production and control of dosage forms
  • stability of the dosage form
  • date to support withdrawal periods

You may also cross-refer to relevant studies submitted in support of already registered VHRs which are held by the VMD and to which you have access rights.

The data and documents required in support of an application to renew a registration are annexed to the renewal application form.

Validation

All applications are checked (validated) upon receipt.

It is up to you to identify and submit all the necessary information in support of your application. If the application is incomplete, it is likely to fail validation.

Assessment

Once the application has passed validation, it will proceed into the assessment phase.

The timescales may be suspended if we need further information from you.

If the outcome is to approve an application, you will be sent authorisation documentation at the end of the application procedure.

Product Literature

See the SPC and Product Literature guidance page for more details.

Timescales

New registration  
Validation Validated within 10 days of receipt
Initial Assessment Approved, refused, or questions asked within 30 days of validation passed
Company Response If questions asked, you should provide a full company response by the deadline set. The timescales are suspended during this time
Sign-off Approved or refused by Day 50. The timescales may be suspended during this time if further information is required from you
Mock-ups Mock-ups approved within 20 days from receipt of correct versions
Issue Following approval, authorisation documentation will be issued within 10 days

At the end of the initial assessment period you may be sent a consolidated list of questions; however, during the sign-off period and following receipt of your response, assessors may follow up with you on outstanding issues separately.

Renewal  
Validation Validated within 10 days of receipt
Initial Assessment Approved, refused, or questions asked within 60 days of validation passed
Company Response If questions asked, you should provide a full company response within 60 days. This may be extended to 120 days, upon request. The timescales are suspended during this time
Sign-off Approved or refused within 60 days from receipt of a full company response
Mock-ups Mock-ups approved within 20 days from receipt of correct versions
Issue Following approval, authorisation documentation will be issued within 10 days

Fees

Once an application has passed validation, you will be sent an invoice for the fee.

For further information visit the Application fees for animal medicines page.

The fee to renew a registration for a VHR is £320.

The VMD now issues all invoices electronically, so you need to provide a valid email address of where to send the invoice; failure to do so will result in your application being rejected.

Contact

For application specific queries, please contact the staff allocated to your application as advised to you in the validation passed email.

For other general enquiries email postmaster@vmd.defra.gsi.gov.uk

Published 31 March 2016
Last updated 26 January 2018 + show all updates
  1. Guidance reviewed with addition of timescales for provision of mock-ups.
  2. First published.