Part 7Amendment to Part 6 (Manufacture and Importation of Investigational Medicinal Products)

Amendment to regulation 43

regulation 30 + 30.—(1) Regulation 43 (qualified persons) is amended as follows.

(2) In paragraph (2A)(b)(1), for “Article 13 of the Directive” substitute “Article 62 of the EU Regulation”.

(3) In paragraph (2C)(b), after “Commission Directive 2003/94/EC” insert “in respect of Great Britain or Commission Delegated Regulation 2017/1569 in respect of Northern Ireland”.

(4) In paragraph (5)(2), for “the said Article 49 or 50” substitute “Schedule 7 to the 2012 Regulations”.

(5) In paragraph (6)(a)(i), for “the said Articles 49 or 50 of Directive 2001/83/EC” substitute “Schedule 7 to the 2012 Regulations”.