# The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025, Article 6: Assembly of investigational medicinal products in hospitals and health centres


(1) Regulation 37 of the Medicines for Human Use (Clinical Trials) Regulations 2004 (exemption for hospitals and health centres) is amended as follows.
(2) In paragraph (2)(a)—
(a) after “carried out”, omit “in”; and
(b) in paragraph (ii), after “of a pharmacist” insert “or, in Great Britain, in accordance with paragraph (3) or (4)”.
(3) After paragraph (2) insert—
“(3) Something is done in accordance with this paragraph if it is done in Great Britain in a hospital aseptic facility in the course of the provision of a relevant pharmacy service, and—
(a) it is done as part of a clinical process; and
(b) it is done by or under the supervision of a registered pharmacy technician.
(4) Something is done in accordance with this paragraph if it is done in Great Britian and—
(a) it is done (not relying on paragraph (3))—
(i) by a registered pharmacy technician who has the authorisation of a pharmacist to do it, or
(ii) under the supervision of a registered pharmacy technician who has the authorisation of a pharmacist to supervise the doing of it; and
(b) it is done with due regard to patient safety.
(5) For the purposes of paragraph (3), a pharmacy service is a “relevant pharmacy service” if conditions A and B in section 67F of the Medicines Act 1968 (sections 67A to 67D: “relevant pharmacy service”) are met in respect of it.
(6) An authorisation given to a registered pharmacy technician for the purposes of paragraph (4)(a)(i) or (ii)—
(a) may be general or specific,
(b) may be given orally or in writing,
(c) may be given subject to conditions or restrictions, and
(d) may be varied or withdrawn by the pharmacist by whom it is given.
(7) An authorisation given for the purposes of paragraph (4)(a)(i) must state, in relation to anything it authorises a registered pharmacy technician to do, that it authorises the registered pharmacy technician to do it only in a hospital or health centre specified in the authorisation.
(8) An authorisation given for the purposes of paragraph (4)(a)(ii) must state, in relation to anything it authorises the registered pharmacy technician to supervise, that it authorises the registered pharmacy technician to supervise it only if it is done in a hospital or health centre specified in the authorisation.
(9) In giving an authorisation for the purposes of paragraph (4)(a)(i) or (ii), a pharmacist must have due regard to patient safety.
(10) A failure to comply with paragraph (9)—
(a) does not affect the validity of the authorisation, but
(b) may constitute misconduct for the purposes of section 80 of the Medicines Act 1968 (power for relevant disciplinary committee to disqualify and direct removal from register) or article 51(1)(a) of the Pharmacy Order 2010 (impairment of fitness to practise) and the relevant disciplinary committee may deal with any such failure accordingly.”.

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Source: https://www.legislation.gov.uk/ukdsi/2025/9780348274202/article/6 (the official version)
Page: https://openlegislation.uk/draft-human-medicines-authorisation-by-pharmacists-and-supervision-by-pharmacy-technicians-order-2025/article-6
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.