Regulation 34 Amendment of Schedule 8

In Schedule 8 (material to accompany an application for a UK marketing authorisation) after paragraph 9 insert—

“9A.

A written confirmation that the manufacturer of the medicinal product has verified compliance of the manufacturer of the active substance with the principles and guidelines of good manufacturing practice by conducting audits, in accordance with regulation 37(5)(a) and containing—

(a)

information about the date of the audit; and

(b)

a declaration that the outcome of the audit confirms that the manufacturing complies with the principles and guidelines of good manufacturing practice.”