Paragraph 21F Self-inspection programmeF1

England, Wales and Scotland

(1)

The holder of a wholesale dealer’s authorisation must have in place a self-inspection programme which ensures that every aspect of its business is inspected at least once a year in order to ensure that it is complying with good distribution practice.

(2)

Where, as a result of the self-inspection mentioned in sub-paragraph (1), the holder identifies any non-compliance the holder must—

(a)

make a record of that fact,

(b)

conduct an investigation for the purpose of discovering the cause of the non-compliance, and

(c)

maintain records of that investigation.

(3)

The holder must keep the records mentioned in sub-paragraph (2) for a period of five years from the date of the audit and the Secretary of State may require the holder to provide a copy of them at any time within that period.

Annotations

Textual amendments

F1: Sch. 3 paras. 21A-21F inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 116