# The Veterinary Medicines Regulations 2013, Paragraph 59: Annual benefit-risk reports

Extent: E+W+S

(1) The marketing authorisation holder must submit to the Secretary of State a summary of pharmacovigilance activity in the form of an annual benefit-risk report for each marketing authorisation in accordance with this paragraph ....
(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(3) Following the placing on the market in Great Britain, the marketing authorisation holder must submit a benefit-risk report to the Secretary of State immediately upon request 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 submission dates for the annual benefit-risk reports.
(5) The report must include a statement regarding the benefit-risk balance of the veterinary medicinal product.
(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.
(7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(8) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

---
Source: https://www.legislation.gov.uk/uksi/2013/2033/schedule/1/paragraph/59 (the official version)
Page: https://openlegislation.uk/veterinary-medicines-regulations-2013/schedule-1/paragraph-59
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.