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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.
Type of variation | UK is the reference member State (£) | UK is a concerned member State (£) |
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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— | ||
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the fee payable is— | ||
| 5,200 | 3,120 |
| 685 | 455 |
If a marketing authorisation holder— | ||
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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— | ||
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the fee payable is— | ||
| 1,325 | 885 |
| 685 | 455 |