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The Veterinary Medicines Regulations 2013
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Rhagor o Adnoddau
Changes over time for: Paragraph 18
Version Superseded: 17/05/2024
Alternative versions:
- 31/12/2020- Amendment
- 01/10/2023
Point in time - 17/05/2024- Amendment
Status:
Point in time view as at 01/10/2023. There are multiple versions of this provision on screen. These apply to different geographical extents. This version of this provision has been superseded.
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Changes to legislation:
There are currently no known outstanding effects for the The Veterinary Medicines Regulations 2013, Paragraph 18.
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Application for a variation to a marketing authorisation dealt with under worksharing proceduresE+W+S
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Memorandwm Esboniadol
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/.
[F1(2) The fees for a worksharing application are specified in the following table.]
F2(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F2(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F2(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| Type of application | F3... | F4... | F4... | ||||||
|---|---|---|---|---|---|---|---|---|---|
| F4... | F4... | F4... | F4... | F4... | F4... | ||||
Worksharing applications The following fees apply for each change to each product: | |||||||||
| Type II | |||||||||
| For the first nine changes: | 6,240 | F4... | F4... | F4... | F4... | F4... | F4... | ||
| For each subsequent group of up to ten changes: | 4,500 | F4... | F4... | F4... | F4... | F4... | F4... | ||
| Type IB | ... | ||||||||
| For the first nine changes: | 1,770 | F4... | F4... | F4... | F4... | F4... | F4... | ||
| For each subsequent group of up to ten changes: | 4,500 | F4... | F4... | F4... | F4... | F4... | F4... | ||
Textual Amendments
F1Sch. 7 para. 18(2) substituted (E.W.S.) (31.12.2020) by The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(j)(i); 2020 c. 1, Sch. 5 para. 1(1)
F2Sch. 7 para. 18(3)-(5) omitted (E.W.S.) (31.12.2020) by virtue of The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(j)(ii); 2020 c. 1, Sch. 5 para. 1(1)
F3Words in Sch. 7 para. 18 Table omitted (E.W.S.) (31.12.2020) by virtue of The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(j)(iii)(aa); 2020 c. 1, Sch. 5 para. 1(1)
F4Words in Sch. 7 para. 18 Table omitted (E.W.S.) (31.12.2020) by virtue of The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(j)(iii)(bb); 2020 c. 1, Sch. 5 para. 1(1)
Application for a variation to a marketing authorisation dealt with under worksharing proceduresN.I.
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 | ||
Extent Information
E1This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
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