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Paragraph 59 Annual benefit-risk reportsF13E1

England, Wales and Scotland

(1)

The marketing authorisation holder must submit to the Secretary of State F1a summary of pharmacovigilance activity in the form of F2an annual benefit-risk report for each marketing authorisation in accordance with this paragraph F3....

F4(2)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3)

Following the placing on the market in F5Great Britain, the marketing authorisation holder must submit a F6benefit-risk report to the Secretary of State immediately upon F7request and, in any event, once in the course of every year during the period of validity of the authorisation.

(4)

Following the granting of a marketing authorisation, the marketing authorisation holder may apply to the Secretary of State to change the F8submission dates for the annual benefit-risk reports.

F9(5)

The report must include a statement regarding the benefit-risk balance of the veterinary medicinal product.

F10(6)

The annual benefit-risk report must include—

(a)

the volume of the product sold in the United Kingdom and in other countries in the period covered by the report, with the volume of the product sold in the United Kingdom in each calendar year identified;

(b)

the notification of signals detected during the reporting period following pharmacovigilance activity in the United Kingdom or a country other than the United Kingdom for which further regulatory actions are required (including a summary of the regular review of adverse events carried out during the year); and

(c)

where it appears from the observed data that there is cause for concern in relation to the safety of the product, recommendations on the need for further intervention by the Secretary of State.

F11(7)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F12(8)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Annotations

Textual amendments

F1

Words in Sch. 1 para. 59(1) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 71(a)(i)

F2

Words in Sch. 1 para. 59(1) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 71(a)(ii)

F3

Words in Sch. 1 para. 59(1) omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 71(a)(iii)

F4

Sch. 1 para. 59(2) omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 71(b)

F5

Words in Sch. 1 para. 59(3) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 71(c)(i)

F6

Words in Sch. 1 para. 59(3) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 71(c)(ii)

F7

Words in Sch. 1 para. 59(3) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 71(c)(iii)

F8

Words in Sch. 1 para. 59(4) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 71(d)

F9

Sch. 1 para. 59(5) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 71(e)

F10

Sch. 1 para. 59(6) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 71(f)

F11

Sch. 1 para. 59(7) omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 71(g)

F12

Sch. 1 para. 59(8) omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 71(g)

F13

Words in Sch. 1 para. 59 heading substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 71(h)

Extent

E1

This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Notes on Schedule 1

Textual amendments

F1

Words in Sch. 1 heading inserted (E.W.S.) (31.12.2020) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(b), 4(7)(a)

F2

Words in Sch. 1 heading inserted (N.I.) (31.12.2020) by The Animals (Health, Identification, Trade and Veterinary Medicines) (Amendment) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/353), regs. 1(3), 10(13)(a)