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The Veterinary Medicines Regulations 2013

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[F3Annual benefit-risk] reportsE+W+S

This section has no associated Explanatory Memorandum

59.—(1) The marketing authorisation holder must submit to the Secretary of State [F4a summary of pharmacovigilance activity] in the form of [F5an annual benefit-risk report] for each marketing authorisation in accordance with this paragraph F6....

F7(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) Following the placing on the market in [F8Great Britain], the marketing authorisation holder must submit a [F9benefit-risk report] to the Secretary of State immediately upon [F10request 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 [F11submission dates for the annual benefit-risk reports].

[F12(5) The report must include a statement regarding the benefit-risk balance of the veterinary medicinal product.]

[F13(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.]

F14(7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F15(8) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Periodic safety update reportsN.I.

59.—(1) The marketing authorisation holder must submit to the Secretary of State records of all adverse reactions (including nil reports) in the form of a periodic safety update report for each marketing authorisation in accordance with this paragraph, including a summary of each incident and a list of all the symptoms using internationally recognised veterinary and medical terminology.

(2) A marketing authorisation holder who has not yet placed a product on the market in [F16Northern Ireland] must submit a periodic safety update report immediately upon request of the Secretary of State and at least every six months after authorisation.

(3) Following the placing on the market in [F17Northern Ireland], the marketing authorisation holder must submit a periodic safety update report to the Secretary of State immediately upon request and—

(a)at least every six months during the first two years following the initial placing on the market;

(b)once a year for the following two years; and

(c)thereafter, at three-yearly intervals.

(4) Following the granting of a marketing authorisation, the marketing authorisation holder may apply to the Secretary of State to change the periods of notification.

(5) The periodic safety update report must include a scientific evaluation of the risk-benefit balance of the veterinary medicinal product.

(6) The periodic safety update report must include—

(a)the volume of the product sold in each year covered by the report, calculated on an annual basis beginning 1st January;

(b)the number of adverse reactions for each year of the report;

(c)the ratio of adverse reactions to volume of product sold for each year of the report, together with an explanation of the basis of the calculation;

(d)differentiation of data based on—

(i)target species (if the product is authorised for use in more than one species);

(ii)reaction type (such as serious, non-serious, human, suspected lack of efficacy, unauthorised use or other);

(iii)the country of origin of the report.

(7) If the product is indicated for more than one species, the information in sub-paragraph (6)(c) must be based so far as is practicable on the estimated use of the product.

(8) Data relating to different formulations (either different dosage forms or different strengths) must be provided in separate reports.

Extent Information

E2This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

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