OpenLegislation

Paragraph 60 Release of information by the marketing authorisation holder

United Kingdom

(1)

A marketing authorisation holder must not communicate information relating to pharmacovigilance concerns to F1veterinary surgeons or the general public in relation to its authorised veterinary medicinal product without giving prior or simultaneous notification to the Secretary of State.

(2)

The marketing authorisation holder must ensure that such information is presented objectively and is not misleading.

F2(3)

For the purposes of this paragraph “information” includes any information contained in advertising material.

Annotations

Textual amendments

F1

Words in Sch. 1 para. 60(1) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 72(a)

F2

Sch. 1 para. 60(3) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 72(b)

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)