Regulation 14 I1F1

In Part 3 of the Schedule, in paragraph 1, for the sentence beginning with “All such cases” substitute—

“All such cases must be clearly documented and subject to—

(a)

in relation to Great Britain, the requirements in regulation 7;

(b)

in relation to Northern Ireland, the quality management provisions in Articles 11, 12, and 13 of Directive 2002/98/EC.”.