Point in time view as at 06/11/2023.
The Medicines for Human Use (Clinical Trials) Regulations 2004, Section 19 is up to date with all changes known to be in force on or before 04 March 2025. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
19.—[F1(1) This regulation applies to clinical trials involving—
(a)medicinal products for gene therapy and somatic cell therapy, including xenogenic cell therapy;
(b)medicinal products containing genetically modified organisms; or
(c)tissue engineered products.]
(2) Subject to the following provisions of this regulation, the licensing authority may, within the period of 30 days from the date of receipt of a valid request for authorisation of a clinical trial to which this regulation applies—
(a)issue a written authorisation to the sponsor; or
(b)give a notice in writing to the sponsor setting out the grounds for not accepting the request.
(3) The licensing authority shall not authorise a clinical trial involving products for gene therapy if the use of those products in that trial would result in modifications to any subject’s germ line genetic identity.
(4) If the licensing authority considers that it is appropriate to do so, they may consult the relevant committee before deciding whether to authorise a clinical trial.
(5) Where the authority consults the relevant committee in accordance with paragraph (4), the period specified in paragraph (2) shall be extended by a further 90 days.
(6) Where a sponsor is given a notice in accordance with paragraph (2)(b), he may, within the period of 30 days, or such extended period as the licensing authority may in any particular case allow, from the date on which the notice was received, send an amended request to the licensing authority for further consideration.
(7) The licensing authority shall consider a valid amended request and, not later than 90 days, or, in a case falling within paragraph (5), 180 days, from the date on which the original request was received—
(a)issue a written authorisation to the sponsor; or
(b)give a notice in writing to the sponsor setting out the grounds for not accepting the request.
(8) A written authorisation issued under this regulation may contain such conditions as the licensing authority consider appropriate.
(9) If the clinical trial involves a medicinal product for xenogenic cell therapy, the time limits set out in paragraphs (2), (5) and (7) shall not apply and the authority may issue an authorisation or notice under those paragraphs at any time after receipt of the request.
(10) In this regulation, “the relevant committee” means—
(a)the [F2Commission on Human Medicines F3...]; or
(b)such other body or committee as the licensing authority may consider appropriate in relation to the application under consideration.
Textual Amendments
F1Reg. 19(1) substituted (19.8.2010) by The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010 (S.I. 2010/1882), regs. 1(1), 9(3)
F2Words in reg. 19(10)(a) substituted (30.10.2005) by The Medicines (Advisory Bodies) (No. 2) Regulations 2005 (S.I. 2005/2754), reg. 1(2)(b), Sch. 3 para. 2
F3Words in reg. 19(10) omitted (14.8.2012) by virtue of The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 55 (with Sch. 32)
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