2024 No. 68
The Human Medicines (Amendments Relating to Coronavirus and Influenza) Regulations (Northern Ireland) 2024
Laid before Assembly in draft
Made
Coming into force in accordance with regulation 1(2)
The Department of Health, 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 20211.
The Department of Health 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 Department of Health’s overarching objective in making these Regulations is safeguarding public health, the Department of Health 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(2), (3) and (6)(b) of that Act, a draft of these Regulations has been laid before, and approved by resolution of the Assembly.
Citation, commencement and extentI11
1
These Regulations may be cited as the Human Medicines (Amendments Relating to Coronavirus and Influenza) Regulations (Northern Ireland) 2024.
2
These Regulations shall come into operation on 31st March 2024.
3
These Regulations extend to Northern Ireland.
Amendment of the Human Medicines Regulations 2012I22
The Human Medicines Regulations 20122 are amended in accordance with Regulations 3 to 5.
Amendment of regulation 3AI33
In regulation 3A3(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 19I44
In regulation 194(exemptions from requirement for wholesale dealer’s licence), in paragraph (4D), for “2024” substitute “2026”
.
Amendment of regulation 247AI55
1
Regulation 247A5(protocols relating to coronavirus and influenza vaccinations and immunisations) is amended as follows.
2
Omit paragraph (2).
3
Omit paragraph (6).
4
At the end, insert—
7
This regulation ceases to have effect on 1st April 2026.
Sealed with the Official Seal of the Department of Health on 20th March 2024.
(This note is not part of the Regulations)