The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025
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Change 1
12 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.
12 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.
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