Statutory Rules of Northern Ireland
Medicines
Laid before Assembly in draft
Made
20th March 2024
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 2021(1).
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.
1.—(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.
Commencement Information
I1Reg. 1 in operation at 31.3.2024, see reg. 1(2)
2. The Human Medicines Regulations 2012(2) are amended in accordance with Regulations 3 to 5.
Commencement Information
I2Reg. 2 in operation at 31.3.2024, see reg. 1(2)
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”.
Commencement Information
I3Reg. 3 in operation at 31.3.2024, see reg. 1(2)
4. In regulation 19(4)(exemptions from requirement for wholesale dealer’s licence), in paragraph (4D), for “2024” substitute “2026”.
Commencement Information
I4Reg. 4 in operation at 31.3.2024, see reg. 1(2)
5.—(1) Regulation 247A(5)(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.”.
Commencement Information
I5Reg. 5 in operation at 31.3.2024, see reg. 1(2)
Sealed with the Official Seal of the Department of Health on 20th March 2024.
(L.S.)
Cathy Harrison
A senior officer of the Department of Health
(This note is not part of the Regulations)
These Regulations amend the Human Medicines Regulations 2012 (“the 2012 Regulations”) which govern the arrangements across the United Kingdom for the licensing, manufacture, wholesale dealing and sale or supply of medicines for human use. These Regulations extend to Northern Ireland only.
Regulation 3 amends regulation 3A of the Human Medicines Regulations 2012, and regulation 4 amends regulation 19. These provisions currently cease to have effect on 1st April 2024, and this is extended to 1st April 2026. Regulation 3A of the 2012 Regulations ensures that all professionally justified acts of preparation and assembly of a coronavirus vaccine may be undertaken by or under the supervision of a doctor, nurse or pharmacist, at any location, without precipitating the need for a manufacturer’s licence or marketing authorisation — provided those acts are done under NHS arrangements or arrangements as part of the medical services of His Majesty’s Forces. It also allows for authorised medicinal products used for the reformulation of coronavirus vaccines (for example, diluents) to be re-assembled at the end of the medicines supply chain without the resultant products needing a marketing authorisation in order to be supplied. Regulation 19 provides for certain exemptions from the requirement to hold a wholesale dealer’s licence, and paragraphs (4A) to (4C) of that regulation permit sharing of stocks of coronavirus and influenza vaccinations between vaccination centres without the need for such a licence.
Regulation 247A exempts from the requirements relating to the supply of medicines under regulations 214, 220 and 221, the supply or administration of a medicinal product used for vaccination or immunisation against coronavirus or influenza virus (of any type), which is made under a national protocol relating to such supply. This regulation removes the requirement, in respect of Northern Ireland, that the supply or administration shall be made whilst a disease is, or is in anticipation of being imminently, a pandemic and a serious risk or potentially serious risk to human health. Regulation 247A will cease to have effect in Northern Ireland on 1st April 2026.
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”. See section 2(6) of that Act, which 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.