# The Veterinary Medicines Regulations 2007, Paragraph 17: Application for a variation to a marketing authorisation that has been issued in other member States


(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:
5,125
3,075
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:
5,125
3,075
– for each subsequent variation:
675
450
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:
1,305
870
Changes to details of the marketing authorisation holder’s pharmacovigilance system (no other changes to the dossier):
1,305
870
Type 1A variation:
675
450
Type 1B variation:
1,305
870
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
1,305
675
– for each subsequent variation
870
450

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Source: https://www.legislation.gov.uk/uksi/2007/2539/schedule/7/paragraph/17 (the official version)
Page: https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-7/paragraph-17
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.