- Latest available (Revised)
- Original (As made)
The Human Medicines (Amendments Relating to Coronavirus and Influenza) Regulations (Northern Ireland) 2024
You are here:
- Previous
- Next
What Version
Advanced Features
- Show Geographical Extent(e.g. England, Wales, Scotland and Northern Ireland)
- Show Timeline of Changes
Opening Options
More Resources
Changes over time for: The Human Medicines (Amendments Relating to Coronavirus and Influenza) Regulations (Northern Ireland) 2024
Alternative versions:
Changes to legislation:
There are currently no known outstanding effects for the The Human Medicines (Amendments Relating to Coronavirus and Influenza) Regulations (Northern Ireland) 2024.
Changes to Legislation
Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.
Statutory Rules of Northern Ireland
2024 No. 68
Medicines
The Human Medicines (Amendments Relating to Coronavirus and Influenza) Regulations (Northern Ireland) 2024
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.
Citation, commencement and extentN.I.
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)
Amendment of the Human Medicines Regulations 2012N.I.
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)
Amendment of regulation 3AN.I.
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)
Amendment of regulation 19N.I.
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)
Amendment of regulation 247AN.I.
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
EXPLANATORY NOTE
(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.
(1)
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.
(2)
S.I. 2012/1916, as amended.
(3)
Regulation 3A was inserted by S.I. 2020/1594 and has been amended by S.I. 2022/350.
(4)
Regulation 19(4D) was inserted by S.I. 2020/1125 and has been amended by S.I. 2022/350.
(5)
Regulation 247A was inserted by S.I. 2020/1125. There have been no relevant amending instruments.
Options/Help
Print Options
PrintThe Whole Rule
Legislation is available in different versions:
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.
See additional information alongside the content
Geographical Extent: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.
Show Timeline of Changes: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.
Opening Options
Different options to open legislation in order to view more content on screen at once
Explanatory Memorandum
Explanatory Memorandum sets out a brief statement of the purpose of a Statutory Rule and provides information about its policy objective and policy implications. They aim to make the Statutory Rule accessible to readers who are not legally qualified and accompany any Northern Ireland Statutory Rule or Draft Northern Ireland Statutory Rule laid before the UK Parliament during the suspension of the Northern Ireland Assembly.
More Resources
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as enacted version that was used for the print copy
- lists of changes made by and/or affecting this legislation item
- confers power and blanket amendment details
- all formats of all associated documents
- correction slips
- links to related legislation and further information resources
Timeline of Changes
This timeline shows the different points in time where a change occurred. The dates will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. The first date in the timeline will usually be the earliest date when the provision came into force. In some cases the first date is 01/02/1991 (or for Northern Ireland legislation 01/01/2006). This date is our basedate. No versions before this date are available. For further information see the Editorial Practice Guide and Glossary under Help.
More Resources
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as made version that was used for the print copy
- correction slips
Click 'View More' or select 'More Resources' tab for additional information including:
- lists of changes made by and/or affecting this legislation item
- confers power and blanket amendment details
- all formats of all associated documents
- links to related legislation and further information resources
All content is available under the Open Government Licence v3.0 except where otherwise stated. This site additionally contains content derived from EUR-Lex, reused under the terms of the Commission Decision 2011/833/EU on the reuse of documents from the EU institutions. For more information see the EUR-Lex public statement on re-use.