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Paragraph 57B Pharmacovigilance inspectionsF1

England, Wales and Scotland

(1)

In relation to a pharmacovigilance inspection the fee is—

(a)

£3,600 in the case of a large marketing authorisation holder; and

(b)

£1,650 in the case of a small marketing authorisation holder.

(2)

In sub-paragraph (1)—

  • “large marketing authorisation holder” means a marketing authorisation holder who holds 30 or more marketing authorisations;

  • “small marketing authorisation holder” means a marketing authorisation holder who holds fewer than 30 marketing authorisations.

Annotations

Textual amendments

F1

Sch. 7 paras. 57A, 57B inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 197