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The Veterinary Medicines Regulations 2013
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Changes over time for: Paragraph 58
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Adverse reactions to a veterinary medicinal product administered in [F3another ] countryE+W+S
This section has no associated Explanatory Memorandum
F458. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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
F3Word in Sch. 1 para. 58 heading substituted (E.W.S.) (31.12.2020) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 3(28)(a) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)
F4Sch. 1 para. 58 omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 70
Adverse reactions to a veterinary medicinal product administered in a third countryN.I.
58.—(1) A marketing authorisation holder for a veterinary medicinal product authorised in [F5Northern Ireland] must act in accordance with this paragraph on learning of any suspected—
(a)serious, unexpected adverse reaction (for these purposes a reaction is unexpected if its nature, severity or outcome is not consistent with the summary of the product characteristics);
(b)human adverse reaction; or
(c)unintended transmission of an infectious agent through a veterinary medicinal product,
following the administration of the product in a third country.
(2) The holder must make a record of what happened.
(3) The holder must without delay and in any event within 15 days report the suspected reaction or transmission (electronically if this is practicable) to the Secretary of State, the competent authorities of all member States in which the product is authorised, and the Agency.
(4) In addition to the report, the holder must supply to the Secretary of State, the competent authorities of all F6... member States where the product is authorised and the Agency, all relevant veterinary pharmacovigilance information in the holder’s possession relating to the reaction as in the preceding paragraph.
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
F5Words in Sch. 1 para. 58(1) substituted (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)(j)(iii)(aa)
F6Word in Sch. 1 para. 58(4) omitted (N.I.) (31.12.2020) by virtue of The Animals (Health, Identification, Trade and Veterinary Medicines) (Amendment) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/353), regs. 1(3), 10(13)(j)(iii)(bb)
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