Regulation 197 New paragraphs 57A and 57B

After paragraph 57 insert—

“Fee in relation to verifying destruction of controlled drug

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^f1 is—

(a)

£142; or

(b)

£31 (where the verification takes place during the course of an inspection for other purposes).

Pharmacovigilance inspections

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.”.