Paragraph 20 Application for a variation

(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) and the appropriate fee is payable for each application.

(3)

If an applicant applies for an extension of a marketing authorisation as specified in Annex II to Commission Regulation (EC) No. 1084/2003—

(a)

if the applicant applies for a United Kingdom marketing authorisation the fee is the same as the fee for the application for a national marketing authorisation, plus any fees payable for any mutual recognition procedure; or

(b)

if the applicant uses the decentralised procedure, the fee is the same as the fee for a marketing authorisation using the decentralised procedure.

(4)

Other fees are in accordance with the following table—

Variations

Type of variation	RMS	CMS
	Fee(£)	Fee(£)
Type II variation	10,125	2,540
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	10,125	2,540
for each subsequent variation	1,675	330
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 lay out 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	2,705	355
Type 1A variation	1,675	330
Type 1B variation	2,705	355
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	2,705	355
for each subsequent variation	1,675	330

Note: the RMS fee is payable when the United Kingdom acts as the reference member State and the CMS fee is payable when the United Kingdom acts as the concerned member State.