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The Veterinary Medicines Regulations 2013
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Application for a variation to a marketing authorisation dealt with under worksharing procedures
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18.—(1) This paragraph applies in relation to an application for a variation to a marketing authorisation dealt with in accordance with worksharing procedures as set out in Article 20 of Commission Regulation (EC) No 1234/.
(2) The fee for a worksharing application, involving marketing authorisations obtained by a national procedure in the United Kingdom only, is the fee specified in the following table in the column headed “UK Only”.
(3) The fee for a worksharing application, involving marketing authorisations obtained through a national procedure in the United Kingdom and any other member State, is specified in the following table by reference to the United Kingdom’s role in the procedure, as “UK Reference Authority”, “UK Co-Reference Authority” or “Other”.
(4) The fee for a worksharing application, involving at least one marketing authorisation obtained through the mutual recognition or decentralised procedure, is specified in the following table by reference to the United Kingdom’s role in the procedure, as “UK Reference Authority”, “UK Co-Reference Authority” or “UK Concerned member State”.
(5) The fee for any kind of variation where the Agency co-ordinates worksharing is £455 for each marketing authorisation.
| Type of application | UK Only | Where the application involves nationally authorised products in more than one member State | Application involves mutually recognised products | ||||||
|---|---|---|---|---|---|---|---|---|---|
UK Only | UK Reference Authority | UK Co-Reference Authority | Other | UK Reference Authority | UK Co-Reference Authority | UK Concerned member State | |||
Worksharing applications The following fees apply for each change to each product: | |||||||||
| Type II | |||||||||
| For the first nine changes: | 6,240 | 12,060 | 7,485 | 12,060 | 13,265 | 6,745 | 3,372 | ||
| For each subsequent group of up to ten changes: | 4,500 | 4,500 | 4,500 | 4,500 | 4,500 | 4,500 | 2,700 | ||
| Type IB | |||||||||
| For the first nine changes: | 1,770 | 2,650 | 2,120 | 2,650 | 2,915 | 1,905 | 954 | ||
| For each subsequent group of up to ten changes: | 4,500 | 4,500 | 4,500 | 4,500 | 4,500 | 4,500 | 2,700 | ||
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