OpenLegislation

Paragraph 17 Application for a variation to a marketing authorisation that has been issued in other member States

Original text. Later amendments are not shown.

(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:5,1253,075

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:5,1253,075
– for each subsequent variation:675450

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:1,305870
Changes to details of the marketing authorisation holder’s pharmacovigilance system (no other changes to the dossier):1,305870
Type 1A variation:675450
Type 1B variation:1,305870

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 variation1,305675
– for each subsequent variation870450