Suspension of a marketing authorisation: procedureE+W+S
39.—(1) If a marketing authorisation is suspended the Secretary of State must notify the holder immediately, and, unless the Secretary of State directs otherwise, the suspension has immediate effect, and continues in effect unless the marketing authorisation is reinstated.
(2) If the suspension is on the grounds of safety, quality or efficacy, the holder may, within 28 days of the notification, appeal to the Veterinary Products Committee.
F3(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F4(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
F3Sch. 1 para. 39(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(23) (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. 39(4) omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 58
Suspension of a marketing authorisation: procedureN.I.
39.—(1) If a marketing authorisation is suspended the Secretary of State must notify the holder immediately, and, unless the Secretary of State directs otherwise, the suspension has immediate effect, and continues in effect unless the marketing authorisation is reinstated.
(2) If the suspension is on the grounds of safety, quality or efficacy, the holder may, within 28 days of the notification, appeal to the Veterinary Products Committee.
(3) If the veterinary medicinal product is authorised in more than one member State, the Secretary of State—
(a)must immediately refer the matter to the Agency, and must comply with a decision of the Commission within 30 days of the decision; and
(b)may suspend the marketing and the use of the veterinary medicinal product in [F5Northern Ireland] pending a decision of the Agency, but must inform the Commission and the F6... member States no later than the following working day of the reasons for the action.
(4) When a marketing authorisation is suspended, the Secretary of State may in addition prohibit the supply of the veterinary medicinal product, and if necessary require the marketing authorisation holder to recall the product.
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. 39(3)(b) 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)(g)(i)
F6Word in Sch. 1 para. 39(3)(b) 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)(g)(i)