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)).