197. After paragraph 57 insert—
57A. The fee for verifying the destruction of a controlled drug listed in Schedule 2, 3 or 4 to the Misuse of Drugs Regulations 2001(1) is—
(a)£142; or
(b)£31 (where the verification takes place during the course of an inspection for other purposes).
57B.—(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.”.