Action taken on account of pharmacovigilanceE+W+S
61.—(1) Where, as a result of the evaluation of veterinary pharmacovigilance data, the Secretary of State considers that a marketing authorisation should be—
(a)suspended;
(b)revoked; or
(c)varied so as to—
(i)restrict the indications;
(ii)change the distribution category;
(iii)amend the dose;
(iv)add a contraindication; or
(v)add a new precautionary measure,
the Secretary of State must forthwith inform F3... and the marketing authorisation holder.
(2) If urgent action is necessary for protecting human or animal health, the Secretary of State may suspend the marketing authorisation of a veterinary medicinal productF4....
F5(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F6(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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
F3Words in Sch. 1 para. 61(1) omitted (E.W.S.) (31.12.2020) by virtue of 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(29)(a) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)
F4Words in Sch. 1 para. 61(2) omitted (E.W.S.) (31.12.2020) by virtue of 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(29)(b) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)
F5Sch. 1 para. 61(3) omitted (E.W.S.) (31.12.2020) by virtue of 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(29)(c) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)
F6Sch. 1 para. 61(4) omitted (E.W.S.) (31.12.2020) by virtue of 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(29)(c) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)
Action taken on account of pharmacovigilanceN.I.
61.—(1) Where, as a result of the evaluation of veterinary pharmacovigilance data, the Secretary of State considers that a marketing authorisation should be—
(a)suspended;
(b)revoked; or
(c)varied so as to—
(i)restrict the indications;
(ii)change the distribution category;
(iii)amend the dose;
(iv)add a contraindication; or
(v)add a new precautionary measure,
the Secretary of State must forthwith inform the Agency, all F7... member States (irrespective of whether the product is authorised in [F8a] member State) and the marketing authorisation holder.
(2) If urgent action is necessary for protecting human or animal health, the Secretary of State may suspend the marketing authorisation of a veterinary medicinal product, but must inform the Agency, the Commission and the F9... member States within one working day.
(3) If, following the opinion of the Agency, the Commission requests the Secretary of State to suspend, withdraw or vary the marketing authorisation, the Secretary of State must comply with that request immediately on a temporary basis.
(4) The Secretary of State must take final measures in accordance with the Decision of the Commission.
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
F7Word in Sch. 1 para. 61(1) 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)(v)(aa)
F8Word in Sch. 1 para. 61(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)(v)(aa)
F9Word in Sch. 1 para. 61(2) 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)(v)(bb)