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The Veterinary Medicines Regulations 2009
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Application for a variation to a marketing authorisation obtained through mutual recognition or decentralised procedures: fees from 1st January 2010
This section has no associated Explanatory Memorandum
18.—(1) This paragraph applies from 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) 1234/2008 (concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products(1)).
(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) except where the variations are grouped in accordance with Article 7 of Commission Regulation (EC) No 1234/2008 (“grouped variations”).
(5) In this paragraph “worksharing” means the procedure set out in Article 20 of Commission Regulation (EC) No 1234/2008.
(6) The fee for any kind of variation where the Agency co-ordinates worksharing is £455 for each marketing authorisation.
(7) In any other case 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 (£) |
|---|---|---|
(a) A co-reference member State is a member State appointed to assist the reference member State in the assessment of specific marketing authorisations. | ||
| Type II variation | ||
| Application for a grouped variation: | 12,060 | 6,240 |
| Any other application: | 6,030 | 3,120 |
| Type II variation using the worksharing procedure | ||
| Application for a grouped variation— | ||
| 13,265 | 5,620 (6,745 where the United Kingdom is co-reference member State(a)) |
| 4,500 | 4,500 |
| Any other application: | 6,630 | 2,810 |
| Type IB variations | ||
| Application for a grouped variation: | 2,650 | 1,770 |
| Any other application: | 1,325 | 885 |
| Type IB variations using the worksharing procedure | ||
| Application for a grouped variation— | ||
| 2,915 | 1,590 (1,910 where the United Kingdom is co-reference member State(a)) |
| 4,500 | 4,500 |
| Any other application: | 1,325 | 885 |
| Type IA variation | ||
| Application for a grouped variation— | ||
| 1,325 | 885 |
| 4,500 | 4,500 |
| Notification under Article 8 of Commission Regulation (EC) No 1234/2008: | 1,325 | 885 |
| Any other application | 685 | 455 |
| Type 1A variation using the worksharing procedure | ||
| Application for a grouped variation— | ||
| 1,460 | 820 |
| 4,500 | 4,500 |
(1)
OJ No L334, 12.12.2008, p. 7. This Regulation supersedes Regulation (EC) No 1084/2003 on 1st January 2010.
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