Regulation 222 Amendment of regulation 331 (findings and reports of inspections)I1

for “marketing authorisation” substitute “UK marketing authorisation, EU marketing authorisation”;

in sub-paragraph (c), at the beginning, insert “in the case of a product authorised under a UKMA(NI) or UKMA(UK),”.

for sub-paragraph (b) substitute—

“(b)

the guidelines on good distribution practice—

(i)

in the case of Great Britain, published under, or that apply by virtue of, regulation C17;

(ii)

in the case of Northern Ireland, published by the European Commission in accordance with Article 84 of the 2001 Directive;”;

after sub-paragraph (c) insert—

“(d)

Schedule 12A; and

(e)

the Implementing Regulation (as defined in regulation 177(5)).”.