Title and introductory text
2025 No. 1249
Medicines
Health Care And Associated Professions
The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025
Made
10th December 2025
Coming into force in accordance with article 1(2) to (5)
At the Court at Buckingham Palace, the 10th day of December 2025
Present,
The King’s Most Excellent Majesty in Council
This Order in Council is made in exercise of the powers conferred by sections 60(1)(a), (2)(h) and (2A)(b) and (c) and 62(4) and (4A) of, and paragraphs 1(e), 2, 3 and 6 of Schedule 3 to, the Health Act 1999.
The Secretary of State published a draft of this Order in Council and invited representations as required by paragraph 9(1) of Schedule 3 to the Health Act 1999.
The period of three months mentioned in paragraph 9(2) of that Schedule expired before a draft of this Order in Council, together with a report about the consultation, was laid before Parliament.
A draft of this Order in Council has been approved by resolution of each House of Parliament in accordance with section 62(9) of the Health Act 1999.
Accordingly, His Majesty is pleased, by and with the advice of His Privy Council, to make the following Order in Council:
Propose a change1 Citation and commencement
(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) 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) article 8(1) in so far as it relates to article 8(2), and article 8(2) and (4);
(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) article 12(19).
Propose a change2 Extent
(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.
Propose a change3 Privy Council procedures and legislative procedures
(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 1946 (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) the fact that the order was duly made; and
(b) the order’s terms.
Propose a change7 Exemptions from prohibition on sale or supply of medicinal products not subject to general sale: two types of authorisation of a pharmacist
(1) The Human Medicines Regulations 2012 are amended in accordance with paragraphs (2) to (4).
(2) In regulation 220 (sale or supply of medicinal products not subject to general sale), in paragraph (2), for sub-paragraph (c) substitute—
(c) P or, if the transaction is carried out on P’s behalf by another person, that other person—
(i) is, or acts under the supervision of, a pharmacist, or
(ii) acts in accordance with regulation 220A or 220B.
.
(3) After regulation 220 insert—
Authorisations given by pharmacists to registered pharmacy technicians
220A. (1) A person acts in accordance with this regulation if what that person does is done with due regard to patient safety, and—
(a) that person is a registered pharmacy technician who has the authorisation of a pharmacist to do it; or
(b) what that person does is done under the supervision of a registered pharmacy technician who has the authorisation of a pharmacist to supervise the doing of it.
(2) An authorisation given for the purposes of paragraph (1)—
(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.
(3) An authorisation given for the purposes of—
(a) paragraph (1)(a) 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 at or from the registered pharmacy specified in the authorisation;
(b) paragraph (1)(b) 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 at or from the registered pharmacy specified in the authorisation.
(4) An authorisation given for the purposes of—
(a) paragraph (1)(a) may (among other things) authorise a registered pharmacy technician to carry out transactions that relate to prescriptions received at the registered pharmacy specified in the authorisation after the authorisation is given;
(b) paragraph (1)(b) may (among other things) authorise a registered pharmacy technician to supervise the carrying out of transactions that relate to prescriptions received at the registered pharmacy specified in the authorisation after the authorisation is given.
(5) In giving an authorisation for the purposes of paragraph (1)(a) or (b), a pharmacist must have due regard to patient safety.
(6) A failure to comply with paragraph (5)—
(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.
(7) This regulation does not apply in relation to Northern Ireland.
.
(4) Before regulation 221 insert—
Sale or supply of items dispensed by a pharmacist who is absent or treated as absent
220B. (1) A person (P1) acts in accordance with this regulation where—
(a) the transaction relates to a medicinal product that has been dispensed by or under the supervision of a pharmacist (P2) and is ready for sale or supply to or for the person for whom it has been dispensed;
(b) P2 authorises P1 to carry out the transaction in question on P2’s behalf in P2’s absence; and
(c) P1 carries out that transaction on P2’s behalf—
(i) in P2’s absence, or
(ii) in circumstances where P2 is treated as being absent,
in accordance with any conditions or restrictions that P2 has imposed pursuant to paragraph (2), sub-paragraphs (b) or (c) (and the authorisation has not been withdrawn).
(2) An authorisation given for the purposes of paragraph (1)(b)—
(a) may be given orally or in writing;
(b) may be given subject to conditions or restrictions; and
(c) may be varied or withdrawn by P2.
(3) In giving an authorisation for the purposes of paragraph (1)(b), P2 must have due regard to patient safety.
(4) A failure to comply with paragraph (3)—
(a) does not affect the validity of any 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.
(5) For the purposes of paragraph (1)(c)(ii), P2 is to be treated as being absent from premises that are a registered pharmacy if P2 is at the pharmacy but not available to intervene in, or not in a position to intervene in, the transaction in question.
.
(5) Pending the coming into force of paragraph (3), the amendment made by paragraph (2) applies as if the reference to regulation 220A were omitted.
Propose a change8 Standards of conduct, ethics and performance related to authorisations
(1) Article 48 of the Pharmacy Order 2010 (standards of conduct and performance) is amended in accordance with paragraphs (2) and (3).
(2) After paragraph (1B) insert—
(1C) The standards set under this article may include standards which relate to the conduct, ethics and performance expected of registered pharmacists giving authorisations for the purposes of regulation 220B(1)(b) of the Human Medicines Regulations 2012.
(1D) Where the standards set under this paragraph include standards of the type mentioned in paragraph (1C), the standards may include a description of the professional responsibilities that the registered pharmacists have—
(a) for the documentation of authorisations given orally, as mentioned in regulation 220B(1)(b)(i) of the Human Medicines Regulations 2012; and
(b) as a consequence of the professional accountability that the registered pharmacists retain for any selling or supplying that is done pursuant to the authorisation that they have given, and in particular for ensuring due regard for patient safety.
.
(3) After paragraph (1D) insert—
(1E) The standards set under this article may include standards which relate to the conduct, ethics and performance expected of registered pharmacists giving authorisations for the purposes of—
(a) section 10(1A)(b)(i) or (ii) of the Medicines Act 1968;
(b) regulation 37(4)(a)(i) or (ii) of the Medicines for Human Use (Clinical Trials) Regulations 2004; or
(c) regulation 220A(1)(a) or (b) of the Human Medicines Regulations 2012.
(1F) Where the standards set under this article include standards of the type mentioned in paragraph (1E), the standards may include a description of the professional responsibilities that the registered pharmacists have—
(a) for the documentation of authorisations given orally, as mentioned in section 10A(1)(b) of the Medicines Act 1968, regulation 37(6)(b) of the Medicines for Human Use (Clinical Trials) Regulations 2004 and regulation 220A(2)(b) of the Human Medicines Regulations 2012; and
(b) as a consequence of the professional accountability that the registered pharmacists retain for any preparing, assembling, dispensing, selling or supplying that is done pursuant to the authorisation that they have given, and in particular for ensuring due regard for patient safety.
.
(4) In paragraph 1 of Schedule 3 to the Pharmacy (Northern Ireland) Order 1976 (standards of conduct and performance), after sub-paragraph (1B) insert—
(1C) The standards set under this paragraph may include standards which relate to the conduct, ethics and performance expected of registered pharmacists giving authorisations for the purposes of regulation 220B(1)(b) of the Human Medicines Regulations 2012.
(1D) Where the standards set under this paragraph include standards of the type mentioned in paragraph (1C), the standards may include a description of the professional responsibilities that the registered pharmacists have—
(a) for the documentation of authorisations given orally, as mentioned in regulation 220B(1)(b)(i) of the Human Medicines Regulations 2012; and
(b) as a consequence of the professional accountability that the registered pharmacists retain for any selling or supplying that is done pursuant to the authorisation that they have given, and in particular for ensuring due regard for patient safety.
.
Propose a change12 Consequential amendments to the Human Medicines Regulations 2012 and transitional provision
(1) The Human Medicines Regulations 2012 are amended in accordance with paragraphs (2) to (19).
(2) In regulation 8(1) (general interpretation), at the appropriate places insert—
“magistral formula product” means a medicinal product that is prepared pursuant to a detailed specification for it that has been provided by an appropriate practitioner;
;
“officinal formula product” means a medicinal product that is prepared pursuant to a detailed specification for it that is in an official pharmacopoeia;
; and
“registered pharmacy technician” has the meaning given in regulation 213(1);
.
(3) In regulation 62 (classification of UK marketing authorisation or parallel import licence), in paragraph (5), after “a pharmacist” insert “or by a person who acts in accordance with regulation 220A or 220B (or an exemption in Chapter 3 of Part 12)”.
(4) In regulation 106 (classification of certificate of registration), in paragraph (2), after “a pharmacist” insert “or by a person who acts in accordance with regulation 220A or 220B (or an exemption in Chapter 3 of Part 12)”.
(5) In regulation 131 (classification of traditional herbal registration), in paragraph (2), after “a pharmacist” insert “or by a person who acts in accordance with regulation 220A or 220B (or an exemption in Chapter 3 of Part 12)”.
(6) In regulation 167 (supply to fulfil special patient needs), in paragraph (2)(b), after “a pharmacist” insert “or, in Great Britain, a registered pharmacy technician”.
(7) In regulation 217B (original pack dispensing), in paragraph (2), for sub-paragraph (b) substitute—
(b) in circumstances where—
(i) a pharmacist is carrying out, supervising or authorising (under regulation 220B) the carrying out of the sale or supply and the pharmacist considers, or
(ii) in Great Britain, a registered pharmacy technician is carrying out or supervising the sale or supply, pursuant to an authorisation (under regulation 220A) given by a pharmacist, and the registered pharmacy technician considers,
in the exercise of their professional skill and judgement, that the sale or supply of a different quantity to that ordered on the prescription may mean that the patient does not, or is not able to, follow the medication regimen intended by the prescriber.
.
(8) In regulation 217BA (original pack dispensing: Northern Ireland), in paragraph (2)(b), for “or supervising” substitute “, supervising or authorising (under regulation 220B) the carrying out of”.
(9) In regulation 217C (original pack dispensing: medicinal products containing a relevant substance), in paragraph (2)—
(a) for sub-paragraph (a) substitute—
(a) the sale or supply is—
(i) by or under the supervision of or pursuant to an authorisation (under regulation 220B) given by a pharmacist, or
(ii) in Great Britain, by or under the supervision of a registered pharmacy technician, pursuant to an authorisation (under regulation 220A) given by a pharmacist; and
;
(b) in sub-paragraph (b), after “the pharmacist” insert “(in a case to which paragraph (a)(i) applies) or registered pharmacy technician (in a case to which paragraph (a)(ii) applies)”.
(10) In regulation 217CA (original pack dispensing: medicinal products containing a relevant substance: Northern Ireland), in paragraph (2)(a), before “a pharmacist” insert “or pursuant to an authorisation (under regulation 220B) given by”.
(11) In regulation 222A (assembly or part assembly as part of “hub and spoke” dispensing arrangements between different businesses), in paragraph (4), after “pharmacist”, at each place it occurs (five times), insert “or (where this may be delegated to them) a registered pharmacy technician”.
(12) In regulation 248 (exemption for certain collection and delivery arrangements), in paragraph (2)(b), after “a pharmacist” insert “or by a person who acts in accordance with regulation 220A or 220B”.
(13) In regulation 250 (exceptions to regulation 249), in paragraph (3), after “a pharmacist” insert “or by a person who acts in accordance with regulation 220A or 220B (or an exemption in Chapter 3 of Part 12)”.
(14) In regulation 255 (offences relating to dealings with medicinal products), in paragraph (1)(c), omit “otherwise than by or under supervision of pharmacist”.
(15) In regulation 274 (exemptions from regulation 273), in paragraph (2)(a), after “a pharmacist” insert “or, in Great Britain, a registered pharmacy technician pursuant to an authorisation (under regulation 220A) given by a pharmacist”.
(16) In regulation 346(2)(c) (review)—
(a) after paragraph (xxviiie) insert—
(xxviiieza) 220A,
; and
(b) before paragraph (xxviiiea) insert—
(xxviiiezb) 220B,
.
(17) In Schedule 25 (packaging requirements: specific provisions), in Part 1 (medicines on prescription), in paragraph 6A, after “pharmacist” at each place it occurs (four times), insert “or (where this may be delegated to them) a registered pharmacy technician”.
(18) In Schedule 26 (packaging requirements: special provisions), in Part 2 (pharmacy exceptions), in paragraph 10A, after “pharmacist” at each place it occurs (four times), insert “or (where this may be delegated to them) a registered pharmacy technician”.
(19) Pending the coming into force of article 7(3)—
(a) the amendments made by paragraphs (3), (4), (5), (12), (13) and (15) apply as if the references to regulation 220A were omitted;
(b) the amendment made by paragraph (7) applies as if the new sub-paragraph (b)(ii) were omitted; and
(c) the amendment made by paragraph (9)(a) applies as if the new sub-paragraph (a)(ii) were omitted.
Propose a change