Statutory Instruments
2022 No. 350
Medicines
The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2022
Made
18th March 2022
Coming into force
31st March 2022
The Secretary of State in relation to England and Wales and Scotland( 1 ), and the Secretary of State and the Department of Health in Northern Ireland acting jointly in relation to Northern Ireland( 2 ), in exercise of the powers conferred by sections 2(1)( 3 ), 3(1)(a), (c), (d), (j), (n), (2)(a), (c) and (d) of the Medicines and Medical Devices Act 2021( 4 ), and after having considered the matters in section 2(2) to (4) of that Act, make the following Regulations.
The Secretary of State and the Department of Health in Northern Ireland make these Regulations having carried out a public consultation, in accordance with section 45(1) of that Act.
In accordance with section 47(3) and (6)(c) of that Act, a draft of the instrument was laid before Parliament and the Northern Ireland Assembly, and approved by a resolution of each House of Parliament and the Northern Ireland Assembly.
Citation, commencement and extent
(2) These Regulations come into force on 31st March 2022.
(3) These Regulations extend to England and Wales, Scotland and Northern Ireland.
Amendments to the Human Medicines Regulations 2012
2.The Human Medicines Regulations 2012( 5 ) are amended in accordance with regulations 3 to 7.
Amendment to regulation 3A (preparation and assembly of medicinal products used for vaccination or immunisation against coronavirus or in the reformulation of such products)
3. In regulation 3A(6)( 6 ), for “2022” substitute “2024” .
Amendment to regulation 19 (exemptions from requirement for wholesale dealer’s licence)
4. In regulation 19(4D)( 7 ), for “2022” substitute “2024” .
Amendment to regulation 229 (exemption for supply by national health service bodies and local authorities)
5. Omit regulation 229(4)( 8 ).
Amendment to regulation 233 (exemption for supply etc under a PGD by person conducting a retail pharmacy business)
6. Omit regulation 233(9)( 9 ).
Amendment to regulation 235 (exemption for sale, supply or administration by certain persons)
7. Omit regulation 235(8)( 10 ).
Signed by authority of the Secretary of State for Health and Social Care
Kamall
Parliamentary Under-Secretary of State,
Department of Health and Social Care
18th March 2022
Sealed with the Official Seal of the Department of Health in Northern Ireland 18th March 2022
Cathy Harrison
A senior officer of the Department of Health in Northern Ireland
Section 2(1) is exercisable by the “appropriate authority”, and in relation to England and Wales and Scotland, this means the Secretary of State, as defined in section 2(6)(a) of the Medicines and Medical Devices Act 2021.
Section 2(1) is exercisable by the “appropriate authority”, and in relation to Northern Ireland, this can mean the Department of Health in Northern Ireland and the Secretary of State acting jointly, as defined in section 2(6)(b)(ii) of the Act.
The “law relating to human medicines” is defined in section 9 of the Act.
S.I. 2012/1916 , as amended.
Regulation 3A, as inserted by S.I. 2020/1594 .
Regulation 19, amended by S.I. 2020/1125 ; there are other amending instruments but none is relevant.
Regulation 229, amended by S.I. 2020/1594 ; there are other amending instruments but none is relevant.
Regulation 233, amended by S.I. 2020/1594 ; there are other amending instruments but none is relevant
Regulation 235, amended by S.I. 2020/1125 .