PART 17Amendment of Part 16 (enforcement)
Amendment of regulation 331 (findings and reports of inspections)I1222
1
Regulation 331 is amended as follows.
F12
In paragraph (1)—
a
for “marketing authorisation” substitute “UK marketing authorisation, EU marketing authorisation”;
b
in sub-paragraph (c), at the beginning, insert “in the case of a product authorised under a UKMA(NI) or UKMA(UK),”.
F23
In paragraph (4)—
a
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;
b
after sub-paragraph (c) insert—
d
Schedule 12A; and
e
the Implementing Regulation (as defined in regulation 177(5)).