The Veterinary Medicines Regulations 2009 No. 2297

SCHEDULE 7 Fees

PART 2 Fees relating to marketing authorisations

Application for a variation to a marketing authorisation obtained through mutual recognition or decentralised procedures: fees until 1st January 2010

17.—(1) This paragraph applies until 1st January 2010.

(2) It applies in relation to an application for a variation to a marketing authorisation obtained through mutual recognition or decentralised procedures.

(3) In this paragraph the types of variation are those specified in Commission Regulation (EC) 1084/2003.

(4) 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).

(5) 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:	5,200	3,120
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:	5,200	3,120
for each subsequent variation:	685	455
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:	1,325	885
Changes to details of the marketing authorisation holder’s pharmacovigilance system (no other changes to the dossier)	1,325	885
Type 1A variation:	685	455
Type 1B variation:	1,325	885
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	1,325	885
for each subsequent variation	685	455