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.
2020 No. 1594
The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020
Made
Laid before Parliament
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 19721. They have been designated for the purposes of section 2(2) of that Act in relation to medicinal products2.
Citation and commencement1
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 20193.
Revocation of provisions of the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 20202
The following provisions of the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 20204 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 20123
The Human Medicines Regulations 20125 are amended as follows.
New regulation 3A4
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 products3A
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
6
This regulation ceases to have effect on 1st April 2022.
Amendment of regulation 2295
In regulation 2298 (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 2306
In regulation 2309 (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 2317
In regulation 23110 (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 2338
In regulation 23311 (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 2349
In regulation 23412 (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 27710
In regulation 27713 (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 27911
In regulation 27914 (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;
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 28012
In regulation 28015 (general principles), in paragraph (4), for “279(a) or (b) to (d)” substitute “281(1)(a) to (e)”.
Amendment of regulation 29313
In regulation 29316 (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 29514
In regulation 29517 (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.
(This note is not part of the Regulations)