Legislation – The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2022

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Introduction

1 Citation, commencement and extent

2 Amendments to the Human Medicines Regulations 2012

3 Amendment to regulation 3A (preparation and assembly of medicinal products used for vaccination or immunisation against coronavirus or in the reformulation of such products)

4 Amendment to regulation 19 (exemptions from requirement for wholesale dealer’s licence)

5 Amendment to regulation 229 (exemption for supply by national health service bodies and local authorities)

6 Amendment to regulation 233 (exemption for supply etc under a PGD by person conducting a retail pharmacy business)

7 Amendment to regulation 235 (exemption for sale, supply or administration by certain persons)

Signature

Explanatory note

The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2022
1Citation, commencement and extent
2Amendments to the Human Medicines Regulations 2012
3Amendment to regulation 3A (preparation and assembly of medicinal products used for vaccination or immunisation against coronavirus or in the reformulation of such products)
4Amendment to regulation 19 (exemptions from requirement for wholesale dealer’s licence)
5Amendment to regulation 229 (exemption for supply by national health service bodies and local authorities)
6Amendment to regulation 233 (exemption for supply etc under a PGD by person conducting a retail pharmacy business)
7Amendment to regulation 235 (exemption for sale, supply or administration by certain persons)
2022 No. 350
Medicines

The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2022

Made
Coming into force
The Secretary of State in relation to England and Wales and Scotland1, and the Secretary of State and the Department of Health in Northern Ireland acting jointly in relation to Northern Ireland2, 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 20214, 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.

1

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.

2

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.

3

The “law relating to human medicines” is defined in section 9 of the Act.