Medicines Citation and commencement 1 1 These Regulations may be cited as the Human Medicines (Coronavirus) (Further Amendments) Regulations 2020. 2 Subject to paragraph (3), these Regulations come into force on the day after the day on which they are laid before Parliament. 3 Regulations 2, 5(c), 6, 7, 8(a) and 9 to 14 come into force immediately after the coming into force of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 . Revocation of provisions of the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 2 The following provisions of the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 are revoked— a regulation 7 (amendment of regulation 229); b regulation 8 (amendment of regulation 230); c regulation 9 (amendment of regulation 231); d regulation 10 (amendment of regulation 233); e regulation 11 (amendment of regulation 234); f regulation 17 (amendment of regulation 279); g regulation 25 (amendment of regulation 293); and h regulation 27 (amendment of regulation 295). Amendment of the Human Medicines Regulations 2012 3 The Human Medicines Regulations 2012 are amended as follows. New regulation 3A 4 After regulation 3 (scope of these Regulations: special provisions), insert— Preparation and assembly of medicinal products used for vaccination or immunisation against coronavirus or in the reformulation of such products 3A 1 Regulations 17(1) (manufacturing of medicinal products) and 46 (requirement for authorisation) do not apply in circumstances where a medicinal product used for vaccination or immunisation against coronavirus is manufactured, prepared or assembled by or under the supervision of a doctor, a registered nurse or a pharmacist— a who is acting in the course of his or her profession; and b for the purposes of the supply or administration of the medicinal product to a patient under relevant arrangements. 2 Regulation 46 does not apply in respect of a medicinal product— a which is the result of the assembly of an authorised medicinal product; b which is used for the reformulation of a medicinal product used for vaccination or immunisation against coronavirus; and c the assembly of which (as mentioned in sub-paragraph (a)) is— i in accordance with a manufacturer’s licence, or ii undertaken in circumstances where regulation 17(1) does not apply by virtue of regulation 3 (scope of these regulations: special provisions) or regulation 4 (special provisions for pharmacies etc.). 3 Regulation 17(1) does not apply in circumstances where a medicinal product used for vaccination or immunisation against coronavirus is labelled by a holder of a wholesale dealer’s licence to take account of a change to the shelf life of the product because of the thawing of the product. 4 Chapter 1 of Part 13 (requirements for packaging and package leaflets relating to medicinal products)— a does not apply to a medicinal product that is the result of a process of manufacture, preparation or assembly in accordance with paragraph (1) or (2); and b is to be construed as permitting labelling in accordance with paragraph (3), in the case of a product which is otherwise labelled in accordance with that Part. 5 For the purposes of this regulation— “authorised” has the meaning given in regulation 3(15) ; and “relevant arrangements” has the meaning given in regulation 19(4C) (exemptions from requirement for wholesale dealer’s licence). 6 This regulation ceases to have effect on 1st April 2022. . Amendment of regulation 229 5 In regulation 229 (exemption for supply by national health service bodies and local authorities)— a in paragraph (1), after “Regulations 214(1)” insert “and (2)”; b after paragraph (2), insert— 2A In relation to a medicinal product that is for parenteral administration, condition A only applies if the person who has given the written directions is an appropriate practitioner in relation to that medicinal product. ; c in paragraph (3)(f), after “is supplied” insert “, either an authorisation by the licensing authority on a temporary basis under regulation 174 or”; and d after paragraph (3), insert— 4 The following cease to have effect on 1st April 2022— a in paragraph (1), “and (2)”; and b paragraph (2A). . Amendment of regulation 230 6 In regulation 230 (exemption for supply etc under a PGD to assist doctors or dentists), in paragraph (8), after “administered” insert “, either an authorisation by the licensing authority on a temporary basis under regulation 174 or”. Amendment of regulation 231 7 In regulation 231 (exemption for supply etc under a PGD by independent hospitals etc), in paragraph (8), after “is supplied” insert “, either an authorisation by the licensing authority on a temporary basis under regulation 174 or”. Amendment of regulation 233 8 In regulation 233 (exemption for supply etc under a PGD by person conducting a retail pharmacy business)— a in paragraph (7), after “administered” insert “, either an authorisation by the licensing authority on a temporary basis under regulation 174 or”; and b after paragraph (7), insert— 8 Regulation 220 does not apply to the supply, or administration, of a prescription only medicine used for vaccination or immunisation against coronavirus or influenza virus where paragraph (1)(a) and (b) applies and conditions A to F are met. 9 Paragraph (8) ceases to have effect on 1st April 2022. . Amendment of regulation 234 9 In regulation 234 (exemption from supply etc of products under a PGD to assist the police etc), in paragraph (9), after “is supplied” insert “, either an authorisation by the licensing authority on a temporary basis under regulation 174 or”. Amendment of regulation 277 10 In regulation 277 (interpretation), in paragraph (1), in the definition of “holder of a temporary authorisation”, for “279(a) or (b) to (d)” substitute “281(1)(a) to (e)”. Amendment of regulation 279 11 In regulation 279 (products without a marketing authorisation etc)— a in paragraph (1), after sub-paragraph (a) insert— aa an authorisation by the licensing authority on a temporary basis under regulation 174; ; and b in paragraph (2), after sub-paragraph (a) insert— aa an authorisation by the licensing authority on a temporary basis under regulation 174; . Amendment of regulation 280 12 In regulation 280 (general principles), in paragraph (4), for “279(a) or (b) to (d)” substitute “281(1)(a) to (e)”. Amendment of regulation 293 13 In regulation 293 (prohibition of supply to the public for promotional purposes), in paragraph (1), after “The holder of” insert “either a temporary authorisation or”. Amendment of regulation 295 14 In regulation 295 (abbreviated advertisements), in paragraph (2)(d), after “the holder” at the first place where it occurs insert “of either the temporary authorisation or”. Signed by the authority of the Secretary of State Bethell Parliamentary Under Secretary of State Department of Health and Social Care 17th December 2020 Robin Swann Minister of Health 17th December 2020 Department of Health in Northern Ireland