The Veterinary Medicines Regulations 2008

Application for a variation to a marketing authorisation that has been issued in other member States

17.—(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	870
for each subsequent variation	675	450