Paragraph 13 I1

After regulation 19 (amendment of regulation 23 (grant or refusal of licence)) insert—

“Amendment of regulation 24 (standard provisions of licences)

19A

In regulation 24, after paragraph (2) insert—

“(3)

In Schedule 4, in relation to a licence holder in Great Britain, references to the principles and guidelines set out in the Good Manufacturing Practice Directive are to those principles and guidelines as they apply under or by virtue of regulation B17.”.”.