331A.—(1) The licensing authority may publish guidelines specifying the principles applicable to inspections referred to in this Part.
(2) Guidelines under paragraph (1) may include the form and content of reports under regulation 331 and of certificates of good manufacturing practice or good distribution practice.
(3) Until the licensing authority exercises its power under paragraph (1), the guidelines adopted by the European Commission under Article 111a of the 2001 Directive, as they had effect immediately before IP completion day, are to continue to apply.]
Textual Amendments
F1Reg. 331A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 223 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 182); 2020 c. 1, Sch. 5 para. 1(1)