The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025
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Change 1
42 Amendment to Schedule 7
(1) Schedule 7 (standard provisions for manufacturing authorisations) is amended as follows. (2) In Part 1 (interpretation)— (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; ; (b) in the definition of “Commission Directive 2003/94/EC” 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)— (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,”; (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,”; (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”; (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)— (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,”; (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”.
42 Amendment to Schedule 7
(1) Schedule 7 (standard provisions for manufacturing authorisations) is amended as follows. (2) In Part 1 (interpretation)— (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; ; (b) in the definition of “Commission Directive 2003/94/EC” 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)— (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,”; (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,”; (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”; (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)— (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,”; (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”.
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