This Statutory Instrument has been made in part in consequence of defects in S.I. 2020/1488 and is being issued free of charge to all known recipients of that Statutory Instrument.
Statutory Instruments
2020 No. 1594
Medicines
The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020
Made
17th December 2020
Laid before Parliament
18th December 2020
Coming into force in accordance with regulation 1(2) and (3)
The Secretary of State and the Minister of Health in Northern Ireland make the following Regulations in exercise of the powers conferred by section 2(2) and (5) of the European Communities Act 1972( 1 ). They have been designated for the purposes of section 2(2) of that Act in relation to medicinal products( 2 ).
Citation and commencement
(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( 3 ).
Revocation of provisions of the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020
(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( 5 ) 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) ( 6 ) ; and
“relevant arrangements” has the meaning given in regulation 19(4C) ( 7 ) (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( 8 ) (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( 9 ) (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( 10 ) (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( 11 ) (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( 12 ) (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( 13 ) (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( 14 ) (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( 15 ) (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( 16 ) (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( 17 ) (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 authority of the Secretary of State for Health and Social Care.
Bethell
Parliamentary Under-Secretary of State,
Department of Health and Social Care
17th December 2020
Robin Swann
Minister of Health,
Department of Health in Northern Ireland
17th December 2020
1972 c. 68 . Section 2(2) was amended by section 27(1)(a) of the Legislative and Regulatory Reform Act 2006 (c. 51) and section 3(3) of, and Part 1 of the Schedule to, the European Union (Amendment) Act 2008 (c. 7) . Section 2(5) was amended by section 41(1) of, and Part 1 of Schedule 6 to, the Northern Ireland Constitution Act 1973 (c. 36) . Section 2 has been repealed by section 1 of the European Union (Withdrawal) Act 2018 (c. 16) (“the 2018 Act”) but, until IP completion day, it continues to have effect, by virtue of subsection (2) of section 1A of the 2018 Act (inserted by section 1 of the European Union (Withdrawal Agreement) Act 2020 (c. 1) (“the 2020 Act”)), as provided by subsections (3) to (5) of that section. For these purposes, “IP completion day” has the meaning given in section 39 of the 2020 Act.
S.I. 2019/775 ; see regulation 1 of those Regulations.
Regulation 3(15) is to be amended by S.I. 2019/775 as amended by S.I. 2020/1488 .
Paragraph (4C) was inserted by S.I. 2020/1125 .
Paragraph (1) of regulation 229 has been amended by S.I. 2013/235 and 2015/323 . Paragraph (3)(f) is to be substituted by S.I. 2019/775 as amended by S.I. 2020/1488 .
Paragraph (8) is to be substituted by S.I. 2019/775 as amended by S.I. 2020/1488 .
Paragraph (8) is to be substituted by S.I. 2019/775 as amended by S.I. 2020/1488 .
Paragraph (7) is to be substituted by S.I. 2019/775 as amended by S.I. 2020/1488 .
Paragraph (9) is to be substituted by S.I. 2019/775 as amended by S.I. 2020/1488 .
The relevant amending instrument is S.I. 2020/1125 .
Regulation 279 is to be substituted by S.I. 2019/775 as amended by S.I. 2020/1488 .
The relevant amending instrument is S.I. 2020/1125 .
Regulation 293(1) is to be substituted by S.I. 2019/775 as amended by S.I. 2020/1488 .
Regulation 295(2)(d) is to be substituted by S.I. 2019/775 as amended by S.I. 2020/1488 .