SCHEDULE 1Marketing authorisations F4in Great BritainF5in Northern Ireland
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)
PART 5Suspension, etc. of a marketing authorisation
Suspension of a marketing authorisation: procedureE139
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.
F33
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F64
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Suspension of a marketing authorisation: procedureE239
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
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.
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)