Part 12Amendment to the Schedules

Amendment to Schedule 7

regulation 42 + 42.—(1) Schedule 7 (standard provisions for manufacturing authorisations) is amended as follows.

(2) In Part 1 (interpretation)—

regulation 42 2 a + (a)before the definition of “Commission Directive 2003/94/EC” insert—

““Commission Delegated Regulation 2017/1569”, in relation to the holder of an authorisation in Northern Ireland, means Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and the guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections, as that Regulation has effect in EU law(1);”;

regulation 42 2 b + (b)in the definition of “Commission Directive 2003/94/EC”(2) omit paragraph (b).

(3) In Part 2 (provisions which may be incorporated in an authorisation relating to the manufacture or assembly of investigational medicinal products)—

regulation 42 3 a + (a)in paragraph 3, after “Commission Directive 2003/94/EC” insert “in respect of Great Britain, or Article 10(1) of Commission Delegated Regulation 2017/1569 in respect of Northern Ireland,”;

regulation 42 3 b + (b)in paragraph 4, after “Commission Directive 2003/94/EC” insert “in respect of Great Britain, or Article 10(2) of Commission Delegated Regulation 2017/1569 in respect of Northern Ireland,”;

regulation 42 3 c + (c)in paragraph 7(a), after “Commission Directive 2003/94/EC” insert “in respect of Great Britain or Article 8 of Commission Delegated Regulation 2017/1569 in respect of Northern Ireland”;

regulation 42 3 d + (d)in paragraph 8, after “Commission Directive 2003/94/EC” insert “in respect of Great Britain or Article 11 of Commission Delegated Regulation 2017/1569 in respect of Northern Ireland”.

(4) In Part 3 (provisions which may be incorporated in an authorisation relating to the importation of investigational medicinal products)—

regulation 42 4 a + (a)in paragraph 2, after “Commission Directive 2003/94/EC” insert “in respect of Great Britain, or Article 10(2) of Commission Delegated Regulation 2017/1569 in respect of Northern Ireland,”;

regulation 42 4 b + (b)in paragraph 5(a), after “Commission Directive 2003/94/EC” insert “in respect of Great Britain or Article 8 of Commission Delegated Regulation 2017/1569 in respect of Northern Ireland”.