The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025

Citation and commencement

1.—(1) This Order may be cited as the Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025.

(2) This article and the listed provisions come into force on the twenty-eighth day after the day on which this Order is made.

(3) This Order, apart from this article and the listed provisions, comes into force on such days as the Privy Council may by order appoint.

(4) Different days may be appointed under paragraph (3) for different purposes or areas.

(5) In this article, “the listed provisions” means—

(a)

(a) articles 2, 3 and 7(1) in so far as it relates to article 7(2) and (4), and article 7(2), (4) and (5);

(b)

(b) article 8(1) in so far as it relates to article 8(2), and article 8(2) and (4);

(c)

(c) article 12(3), (4), (5), (7) to (10), (12) to (14), and (16)(b), and article 12(1) in so far as it relates to article 12(3), (4), (5), (7) to (10), (12) to (14), and (16)(b); and

(d)

(d) article 12(19).

Extent

2.—(1) This Order, apart from articles 9 and 10, extends to England and Wales, Scotland and Northern Ireland.

(2) Articles 9 and 10 extend to England and Wales and Scotland.

Privy Council procedures and legislative procedures

3.—(1) The power vested in the Privy Council to make an order under article 1(3) may be exercised by any two or more members of the Privy Council.

(2) The power vested in the Privy Council to make an order under article 1(3) is exercisable by statutory instrument, and for the purposes of section 1 of the Statutory Instruments Act 1946²(definition of “Statutory Instrument”), that power is to be taken to be conferred by an Act of Parliament.

(3) Any act of the Privy Council under this Order is sufficiently signified by an instrument signed by the Clerk of the Privy Council.

(4) Where an order of the Privy Council under article 1(3) is signified by an instrument purporting to be signed by the Clerk of the Privy Council, that is evidence and in Scotland sufficient evidence of—

(a)

(a) the fact that the order was duly made; and

(b)

(b) the order’s terms.

Exemption from requirement for manufacturer’s licence or marketing authorisation: authorisation of a pharmacist

4.—(1) The Medicines Act 1968³is amended as follows.

(2) In section 10 (exemptions for pharmacists)⁴—

(a)

(a) in subsection (1)—

(b)

(b) after subsection (1) insert—;

(1A) Something is done in accordance with this subsection if—(a) it is done in Great Britain in a registered pharmacy, a hospital, a care home service or a health centre,(b) it is done—(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(c) it is done with due regard to patient safety.

(1B) See section 10A for provision about authorisations given for the purposes of subsection (1A)(b)(i) and (ii).

(c)

(c) in subsection (3), for “Those restrictions” substitute “The restrictions imposed by regulations 17(1) (manufacturing of medicinal products) and 46 (requirement for authorisation) of the 2012 Regulations”;

(d)

(d) in subsection (4), in the words after paragraph (b)—

(e)

(e) in subsection (7A), after “pharmacist” insert “or registered pharmacy technician”; and

(f)

(f) in subsection (7B), after “pharmacist” insert “or registered pharmacy technician”.

(3) After section 10 insert—.

Authorisation for the purposes of section 10(1A)(b)(i) or (ii)10A (1) An authorisation given to a registered pharmacy technician for the purposes of section 10(1A)(b)(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.(2) An authorisation given for the purposes of section 10(1A)(b)(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 registered pharmacy, hospital, care home service or health centre specified in the authorisation.(3) An authorisation given for the purposes of section 10(1A)(b)(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 registered pharmacy, hospital, care home service or health centre specified in the authorisation.(4) An authorisation given for the purposes of section 10(1A)(b)(i) may (among other things) authorise a registered pharmacy technician—(a) to prepare or dispense medicinal products in accordance with prescriptions given after the authorisation is given, or(b) to procure the preparation or dispensing of medicinal products in accordance with prescriptions given after the authorisation is given.(5) An authorisation given for the purposes of section 10(1A)(b)(ii) may (among other things) authorise a registered pharmacy technician to supervise—(a) the preparation or dispensing of medicinal products in accordance with prescriptions given after the authorisation is given, or(b) the procurement of the preparation or dispensing of medicinal products in accordance with prescriptions given after the authorisation is given.(6) In giving an authorisation for the purposes of section 10(1A)(b)(i) or (ii), a pharmacist must have due regard to patient safety.(7) A failure to comply with subsection (6)—(a) does not affect the validity of the authorisation, but(b) may constitute misconduct for the purposes of section 80 of this Act (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.

Exemption from the requirement for manufacturer’s licence or marketing authorisation: registered pharmacy technicians at hospital aseptic facilities

5. After regulation 4 of the Human Medicines Regulations 2012⁵(special provisions for pharmacies etc.) insert—.

Special provisions for registered pharmacy technicians at hospital aseptic facilities4A. (1) The prohibitions in regulations 17(1) (manufacturing of medicinal products: requirement for licence) and 46 (requirement for authorisation) do not apply to anything which is done in Great Britain in a hospital aseptic facility in the course of the provision of a relevant pharmacy service if—(a) it is done as part of a clinical process;(b) it is done by or under the supervision of a registered pharmacy technician;(c) in the case of anything done to a medicinal product prior to the retail sale of the medicinal product or the supply of that product in circumstances corresponding to retail sale, what is done consists of—(i) preparing or dispensing a medicinal product in pursuance of a prescription for a magistral formula product or an officinal formula product, or(ii) preparing, assembling or dispensing a medicinal product that has already been lawfully placed on the market in the United Kingdom, or the component medicinal products or medical devices of which have already been so placed,and is with a view to the retail sale of the medicinal product or the supply of that medicinal product in circumstances corresponding to retail sale;(d) in a case where sub-paragraph (c)(ii) applies, the composition of the medicinal product is not modified by, nor are its components modified by, the preparation, assembly or dispensing in such a way or to the extent that it is appropriate to treat—(i) the retail sale of that medicinal product, or(ii) the supply of that...