Insertion of regulation 331A (guidelines on inspections)U.K.
223. After regulation 331 (finding and reports of inspections) insert—
“Guidelines on inspections
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 [F1IP completion day] M1, are to continue to apply.”.
Textual Amendments
F1Words in reg. 223 substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 182
Commencement Information
I1Reg. 223 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
Marginal Citations
M1The guidelines are available at: https://www.gov.uk/guidance/eu-guidance-documents-referred-to-in-the-human-medicines-regulations-2012 and a hard copy may be obtained from the Medicines and Healthcare products Regulatory Agency at the address given in the Explanatory Note.