Statutory Instruments
2024 No. 344
MEDICINES
The Human Medicines (Amendments Relating to Coronavirus and Influenza) (England and Wales and Scotland) Regulations 2024
Made
6th March 2024
Coming into force
31st March 2024
The Secretary of State makes the following Regulations in exercise of the powers conferred by sections 2(1), 3(1)(a) to (d), (h), (j) and (n) and (2)(a) and (c), 6(1)(b) and 43(2) of the Medicines and Medical Devices Act 2021( 1 ).
The Secretary of State has carried out a public consultation in accordance with section 45(1) of that Act.
In accordance with section 2(2) to (4) of that Act, the Secretary of State’s overarching objective in making these Regulations is safeguarding public health, the Secretary of State has had regard to the matters specified in section 2(3) of that Act and considers that, where these Regulations may have an impact on the safety of human medicines, the benefits of making these Regulations outweigh the risks.
In accordance with section 47(3) and (6)(a) of that Act, a draft of these Regulations has been laid before Parliament and approved by a resolution of each House of Parliament.
Citation, commencement and extent
(2) These Regulations come into force on 31st March 2024.
(3) These Regulations extend to England and Wales, and Scotland.
Amendment of the Human Medicines Regulations 2012
2.The Human Medicines Regulations 2012( 2 ) are amended in accordance with regulations 3 to 5.
Amendment of regulation 3A
3. In regulation 3A( 3 )(preparation and assembly of medicinal products used for vaccination or immunisation against coronavirus or in the reformulation of such products), in paragraph (6), for “2024” substitute “2026” .
Amendment of regulation 19
4. In regulation 19( 4 ) (exemptions from requirement for wholesale dealer’s licence), in paragraph (4D), for “2024” substitute “2026” .
Amendment of regulation 247A
(2) Omit paragraph (2).
(3) Omit paragraph (6).
(4) At the end, insert—
“ (7) This regulation ceases to have effect on 1st April 2026. ” .
Signed by authority of the Secretary of State for Health and Social Care
Maria Caulfield
Parliamentary Under Secretary of State
Department of Health and Social Care
6th March 2024
2021 c. 3 . The powers in section 2(1) of the Medicines and Medical Devices Act 2021, and in the provisions that relate to it, are exercisable by the “appropriate authority”. Section 2(6) of that Act contains the definition of “appropriate authority” that is relevant to the powers being exercised.
S.I. 2012/1916 , as amended.
Regulation 3A was inserted by S.I. 2020/1594 and has been amended by S.I. 2022/350 .
Regulation 19(4D) was inserted by S.I. 2020/1125 and has been amended by S.I. 2022/350 .
Regulation 247A was inserted by S.I. 2020/1125 . There have been no relevant amending instruments.