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”.
Propose a change45 Insertion of Schedule 14
After Schedule 13 (transitional provisions relating to EU Exit) insert—
Schedule 14
Transitional provisions relating to the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025
Regulation 56
Interpretation
1 (1) In this Schedule—
“end of trial date” is the date of the conclusion of the trial that is specified in the protocol of a clinical trial and which, in the case of a clinical trial conducted in other countries as well as the United Kingdom, is the end of the date of the trial in all the participating countries;
“the new rules” means these Regulations as in force on and after the relevant day;
“new rules clinical trial” means a clinical trial which is not an old rules clinical trial;
“old committee” means an ethics committee recognised under the old rules that has been abolished or has ceased to operate as an ethics committee for the purposes of these Regulations;
“the old rules” means these Regulations as in force immediately before the relevant day;
“old rules clinical trial” is to be construed in accordance with paragraph 2(1)(a);
“the relevant day” means the day on which this Schedule comes into force.
(2) Where, by virtue of this Schedule, the old rules continue to apply, regulation 2 of the old rules applies to the interpretation of the old rules, except in so far as it is necessary for regulation 2 of the new rules to apply to their interpretation in order to give effect to a provision of this Schedule (for example, because a new committee is performing functions of an old committee).
(3) For purposes of this Schedule, “sponsor”, in the context of the old rules, has the meaning given in regulation 3 of the old rules.
(4) Regulation 53 of the new rules applies to both the new rules and the old rules.
Application of the old rules to the authorisation etc of existing clinical trials
2 (1) If a request for authorisation to conduct a clinical trial has been received by the licensing authority before the relevant day, or an application for an ethics committee opinion in relation to a clinical trial has been received before the relevant day, Part 3 of the old rules including its related Schedules, rather than Part 3 of the new rules including its related Schedules, applies in respect of—
(a) that trial (an “old rules clinical trial”), including—
(i) the authorisation of that trial and any amended requests for authorisation,
(ii) the giving of an ethics committee opinion in relation to that trial, or a review or appeal relating to such an opinion, and
(iii) information sharing and the publication of information; and
(b) the supply of any investigational medicinal product for a purpose related to that trial,
subject to the following sub-paragraphs.
(2) An ethics committee established under regulation 6(1) of the new rules (“a new committee”) may, with the agreement of the Authority, take over and perform any function under the old rules of an ethics committee recognised under the old rules.
(3) Where a new committee performs functions of an ethics committee under the old rules pursuant to this Schedule, the new committee may, with the agreement of the Authority, regulate its proceedings and business in relation to old rules clinical trials in a manner that is consistent, subject to any necessary modifications, with how it regulates its proceedings and business in relation to new rules clinical trials, provided that there is no detriment to—
(a) the sponsor of an old rules clinical trial; or
(b) achieving the outcome of performing the functions of an old committee under the old rules.
(4) Any recognition of an ethics committee under regulation 7 of the old rules may, with the agreement of the Authority, continue in effect notwithstanding the repeal of regulation 7, but—
(a) solely for the purposes of that committee performing the functions under the old rules of an ethics committee, and Part 2 of the old rules and its related Schedules continue to apply for that purpose; and
(b) subject to any conditions or limitations imposed by the Authority.
(5) In a case where the licensing authority or ethics committee receives a valid notice of amendment to a clinical trials authorisation from a sponsor before the relevant day, Part 3 of the old rules including its related Schedules, rather than Part 3 of the new rules including its related Schedules, applies in respect of that notice of amendment, including—
(a) the giving of a written notice by the licensing authority, and the review of any amended notice of amendment or any appeal relating to such written notice; and
(b) the giving of an opinion by an ethics committee, and the review of any amended notice of amendment,
but no notice of amendment received on or after the relevant day pursuant to the old rules is to be treated as valid.
(6) In a case where the licensing authority serves a notice on a sponsor pursuant to regulation 23 of the old rules before the relevant day, the old rules continue to apply for the purposes of the consideration of representations relating to, and any making of an amendment as a consequence of, that notice.
(7) As regards the modifications to an old rules clinical trial authorisation on and after the relevant day, except in a case to which sub-paragraph (5) or (6) applies, that modification (including a modification that would have been an amendment by the sponsor under regulation 24 of the old rules) is to be made in accordance with and subject to the requirements of the new rules.
(8) Regulation 25 of the new rules applies to old rules clinical trials as it does to new rules clinical trials (including automatic deferrals in regulation 25(10)), except that—
(a) it does not apply to an old rules clinical trial that has an end of trial date that is before the relevant day; and
(b) in the case of an old rules trial that has been approved but its end of trial date is on or after the relevant day—
(i) where, before the relevant day the first individual has not yet been recruited to be a participant in that trial, regulation 25(1) applies as if the reference to approval of the trial were a reference to the relevant day,
(ii) where, before the relevant day the first individual has been recruited to be a participant in that trial, regulation 25(1) applies as if the reference to approval of the trial were a reference to the relevant day and sub-paragraph (a) were omitted, and
(iii) regulation 25(2)(b) does not apply.
Application of Good Clinical Practice to old rules clinical trials
3 (1) Part 4 of the new rules applies in respect of old rules clinical trials as it does in respect of new rules clinical trials, subject to the following sub-paragraph.
(2) Regulation 31A(7) of the old rules, rather than regulation 31A(7) of the new rules, applies in respect of old rules clinical trials.
Pharmacovigilance in respect of old rules clinical trials
4 (1) Part 5 of the new rules applies in respect of old rules clinical trials as it does in respect of new rules clinical trials, subject to the following sub-paragraphs.
(2) The sponsor of an old rules clinical trial may elect that Part 5 of the old rules is to apply, temporarily, in respect of the clinical trial, rather than Part 5 of the new rules, provided that the licensing authority has received notification of that election—
(a) unless paragraph (b) applies, within the period of 60 days beginning with the day after the relevant day;
(b) where, in order to comply with the old rules, a reporting or notification obligation under the old rules needs to be discharged before that 60 day period expires, when or before that reporting or notification obligation is discharged (which must be on or before the latest day on which that reporting notification needs to be discharged in order to comply with the old rules).
(3) Where a sponsor of an old rules clinical trial has made a valid election pursuant to sub-paragraph (2), once the sponsor has discharged their obligations under regulation 35(1) of the old rules, or the period during which the sponsor is required to do so has expired, whichever is the sooner, the election ceases to have effect.
Manufacture and importation of investigational medicinal products used in old rules clinical trials
5 (1) Part 6 of the new rules, including its related Schedules, applies in respect of the manufacture and importation of investigational medicinal products used in old rules clinical trials as it does in respect of the manufacture and importation of investigational medicinal products used in new rules clinical trials, subject to the following sub-paragraph.
(2) Regulation 37A does not apply to radiopharmaceuticals used for diagnostic purposes.
Labelling of investigational medicinal products used in old rules clinical trials
6 Part 7 of the old rules applies in respect of investigational medicinal products used in old rules clinical trials, if those products are manufactured before the relevant day, and in these circumstances investigational medicinal products—
(a) manufactured before the relevant day; and
(b) labelled in accordance with regulation 46 of the old rules,
may continue to be used in a clinical trial for which they are for use, subject to complying with Part 7 of the old rules.
Enforcement etc
7 (1) Where the old rules continue to apply by virtue of this Schedule, with or without modifications, Part 8 of the old rules applies to the enforcement of those old rules, subject to the following sub-paragraph.
(2) Where, by virtue of this Schedule, a provision (whether of the old rules or the new rules) applies with modifications, for the purposes of securing the effective enforcement of that provision as so modified, an enforcement authority may include those modifications in an infringement notice.
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Propose a change