Regulation 223 Insertion of regulation 331A (guidelines on inspections)I1

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.”.