OpenLegislation

Paragraph 14 Application for a variation to a marketing authorisation that has been issued in other member StatesI1

United Kingdom

(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 variationUK is the reference member State (£)UK is a concerned member State (£)
Type II variation:8,9902,220

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:

8,9902,220

  • for each subsequent variation:

1,555440

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:

2,455475
Type 1A variation:1,555440
Type 1B variation:2,455475

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:

2,455475

  • for each subsequent variation:

1,555440

Annotations

Commencement

I1

Sch. 7 para. 14 in force at 1.10.2006, see reg. 1