Paragraph 57 Adverse events following administration of a veterinary medicinal productF11E1
England, Wales and Scotland
A marketing authorisation holder must act in accordance with this paragraph on learning of any suspected—
F1adverse event in respect of an animal;
unintended transmission of an infectious agent through a veterinary medicinal product,
occurrence of an adverse environmental event, or
lack of efficacy,
following the administration of the product F5....
A marketing authorisation holder must also act in accordance with this paragraph where—
after the end of the withdrawal period a product of animal origin is found to include a pharmacologically active substance or marker residue exceeding the maximum residue limit established in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council; or
there is evidence in published scientific literature of an adverse event in connection with the product.
The holder must make a record of what happened.
The holder must without delay and in any event within F730 days report it (electronically if this is practicable) to the Secretary of State.
In addition, the holder must supply to the Secretary of State all relevant veterinary pharmacovigilance information that the holder possesses relating to the F8event, giving a full description of the incident and a list of all the symptoms using internationally recognised veterinary and medical terminology, either with the report or, if the information becomes available after the report has been sent, as soon after it becomes available as is reasonably practicable.
The Secretary of State may require the marketing authorisation holder—
to collect specific pharmacovigilance data (in addition to the data mentioned in sub-paragraph (4)) and submit those data to the Secretary of State; and
to carry out specific post-marketing surveillance studies.
Where the Secretary of State exercises the power mentioned in sub-paragraph (4A), the Secretary of State must—
state the reason for the requirement; and
state the time by which, or the period during which, the requirement must be complied with.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Annotations
Textual amendments
- F1
Words in Sch. 1 para. 57(1)(a) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 69(a)(i)
- F2
Words in Sch. 1 para. 57(1)(b) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 69(a)(ii)(aa)
- F3
Word in Sch. 1 para. 57(1)(b) omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 69(a)(ii)(bb)
- F4
Sch. 1 para. 57(1)(d)(e) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 69(a)(iii)
- F5
Words in Sch. 1 para. 57(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), 69(a)(iv)
- F6
Sch. 1 para. 57(1A) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 69(b)
- F7
Word in Sch. 1 para. 57(3) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 69(c)
- F8
Word in Sch. 1 para. 57(4) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 69(d)
- F9
Sch. 1 para. 57(4A)(4B) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 69(e)
- F10
Sch. 1 para. 57(5) omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 69(f)
- F11
Sch. 1 para. 57 heading substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 69(g)
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)