# The Veterinary Medicines Regulations 2006, Paragraph 14: Application for a variation to a marketing authorisation that has been issued in other member States

Extent: E+W+S+N.I.

(1) In this paragraph the types of variation are those specified in Commission Regulation (EC) 1084/2003.
(2) An applicant must make a separate application for a variation for each change in the marketing authorisation (unless a change is a direct consequence of the first change).
(3) The fee is in accordance with the following table.
Variations
Type of variation
UK is the reference member State (£)
UK is a concerned member State (£)
Type II variation:
8,990
2,220
If a marketing authorisation holder applies for a Type II variation for a number of marketing authorisations, and—
all the applications have identical supporting data
all the changes are identical
all the applications are submitted at the same time the fee payable is—
for the first variation:
8,990
2,220
for each subsequent variation:
1,555
440
If a marketing authorisation holder—
applies for a Type II variation to correct the Summary of Product Characteristics or product literature or where variations are required for simple text layout changes
the change is not a result of safety concerns
no new studies are required to support the change
no other aspects of the dossier are changed the fee payable is:
2,455
475
Type 1A variation:
1,555
440
Type 1B variation:
2,455
475
If a marketing authorisation holder applies for a Type 1B variation for a number of marketing authorisations, and—
all the applications have identical supporting data
all the changes are identical
all the applications are submitted at the same time
the fee payable is—
for the first variation:
2,455
475
for each subsequent variation:
1,555
440

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Source: https://www.legislation.gov.uk/uksi/2006/2407/schedule/7/paragraph/14 (the official version)
Page: https://openlegislation.uk/veterinary-medicines-regulations-2006/schedule-7/paragraph-14
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.