# The Human Medicines (Amendment) Regulations 2026, Regulation 3: Amendment of regulation 3


(1) Regulation 3 (scope of these Regulations: special provisions) is amended as follows.
(2) In paragraph (2), after “paragraph (5A)”, insert “, (5B)”.
(3) After paragraph (5A), insert—
“(5B) This paragraph applies where a medicinal product is manufactured or assembled by a pharmacist—
(a) who is acting in the course of his or her profession; and
(b) where—
(i) the conditions in paragraphs (8) and (9) are met, and
(ii) treatment of the patient with the medicinal product is a treatment decision of the pharmacist.”.
(4) In paragraph (11), after “paragraph (5)”, insert “, (5B)”.
(5) In paragraph (12), in sub-paragraph (b), for “or (5A)” substitute “, (5A) or (5B)”.

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Source: https://www.legislation.gov.uk/ukdsi/2026/9780348278958/regulation/3 (the official version)
Page: https://openlegislation.uk/draft-human-medicines-amendment-regulations-2026/regulation-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.