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Human Medicines Regulations Amendments

The Department of Health and Social Care and MHRA are amending the Human Medicines Regulations through draft regulations and consultation on changes to health service product information disclosure rules, aimed at benefiting NHS patients and British businesses through modernised medicines access procedures. The amendments represent significant changes to the regulatory framework governing medicines approval and provision.


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2026

22 events
29 Apr 2026 | Written question Department of Health and Social Care linked

To ask the Secretary of State for Health and Social Care, if he will publish any of the pre-clinical data, study reports or assessments made by the Medicines and Healthcare products Regulatory Agency

To ask the Secretary of State for Health and Social Care, if he will publish any of the pre-clinical data, study reports or assessments made by the Medicines and Healthcare products Regulatory Agency (MHRA) that the MHRA’s Chief Safety Officer …

29 Apr 2026 | Written question Department of Health and Social Care linked

To ask the Secretary of State for Health and Social Care, what assessment he has made of the potential implications for his Department's policies of the increasing percentage of funding for the World

To ask the Secretary of State for Health and Social Care, what assessment he has made of the potential implications for his Department's policies of the increasing percentage of funding for the World Health Organization coming from (a) specified and …

29 Apr 2026 | Written question Department of Health and Social Care linked

To ask the Secretary of State for Health and Social Care, if he will publish the most recent Medicines and Healthcare products Regulatory Agency (MHRA) pharmacovigilance assessment or signal evaluatio

To ask the Secretary of State for Health and Social Care, if he will publish the most recent Medicines and Healthcare products Regulatory Agency (MHRA) pharmacovigilance assessment or signal evaluation report that specifically addresses potential cancer/n

29 Apr 2026 | Written question Department of Health and Social Care linked

To ask the Secretary of State for Health and Social Care, whether external organisations, including charities and patient organisations, will have opportunities to submit written evidence to any revie

To ask the Secretary of State for Health and Social Care, whether external organisations, including charities and patient organisations, will have opportunities to submit written evidence to any review of meningococcal group B vaccines or meningococcal gr

29 Apr 2026 | Written question Department of Health and Social Care linked

To ask the Secretary of State for Health and Social Care, that the recognition of air ambulance services within NHS emergency services fuel access arrangements is safeguarded and maintained, ensuring

To ask the Secretary of State for Health and Social Care, that the recognition of air ambulance services within NHS emergency services fuel access arrangements is safeguarded and maintained, ensuring priority access in line with other frontline emergency

29 Apr 2026 | Written question Department of Health and Social Care linked

To ask His Majesty's Government what steps they are taking to secure supplies of medicines, medical devices and medical consumables in the case of war or pandemic; and whether those steps include buil

To ask His Majesty's Government what steps they are taking to secure supplies of medicines, medical devices and medical consumables in the case of war or pandemic; and whether those steps include building and maintaining strategic reserves of those suppli

28 Apr 2026 | Written question Department of Health and Social Care linked

To ask the Secretary of State for Health and Social Care, what recent discussions he has had with the Chief Executive of the NHS Business Services Authority on the operation of the Vaccine Damage Paym

To ask the Secretary of State for Health and Social Care, what recent discussions he has had with the Chief Executive of the NHS Business Services Authority on the operation of the Vaccine Damage Payment Scheme.

28 Apr 2026 | Written question Department of Health and Social Care linked

To ask the Secretary of State for Health and Social Care, with reference to his Department’s press release entitled NHS patients and British businesses to benefit from historic changes to medicines ac

To ask the Secretary of State for Health and Social Care, with reference to his Department’s press release entitled NHS patients and British businesses to benefit from historic changes to medicines access following pharmaceutical partnership with USA, pub

28 Apr 2026 | Written question Department of Health and Social Care linked

To ask the Secretary of State for Health and Social Care, what assessment he has made of the potential impact of the US CLOUD Act on the security of NHS patient data held or processed by US-based comp

To ask the Secretary of State for Health and Social Care, what assessment he has made of the potential impact of the US CLOUD Act on the security of NHS patient data held or processed by US-based companies; and whether …

28 Apr 2026 | Written question Department of Health and Social Care linked

To ask the Secretary of State for Health and Social Care, with reference to his Department’s press release entitled NHS patients and British businesses to benefit from historic changes to medicines ac

To ask the Secretary of State for Health and Social Care, with reference to his Department’s press release entitled NHS patients and British businesses to benefit from historic changes to medicines access following pharmaceutical partnership with USA, pub

28 Apr 2026 | Written question Department of Health and Social Care linked

To ask the Secretary of State for Health and Social Care, what information his Department holds on where licenced donor animal blood is sourced from to develop animal blood-enriched agar for use acros

To ask the Secretary of State for Health and Social Care, what information his Department holds on where licenced donor animal blood is sourced from to develop animal blood-enriched agar for use across the NHS; and if he will make …

28 Apr 2026 | Written question Department of Health and Social Care linked

To ask the Secretary of State for Health and Social Care, with reference to his Department’s press release entitled NHS patients and British businesses to benefit from historic changes to medicines ac

To ask the Secretary of State for Health and Social Care, with reference to his Department’s press release entitled NHS patients and British businesses to benefit from historic changes to medicines access following pharmaceutical partnership with USA, pub

2025

11 events
28 Oct 2025 | Consultation (closed) Department of Health and Social Care linked

Extend medicines responsibilities for allied health professions — consultation closed

This consultation seeks views on extending medicines responsibilities for paramedics, physiotherapists, operating department practitioners and diagnostic radiographers.

5 Aug 2025 | Consultation (closed) Department of Health and Social Care linked

Extend medicines responsibilities for allied health professions — consultation opened

This consultation seeks views on extending medicines responsibilities for paramedics, physiotherapists, operating department practitioners and diagnostic radiographers.

17 Jul 2025 | Consultation outcome Department of Health and Social Care linked

Pharmacy supervision — outcome published

DHSC is seeking views on proposals to modernise legislation governing the supervision of activities by a pharmacist in a pharmacy.

14 Jul 2025 | Announcement Department of Health and Social Care linked

International Health Regulations amendments

UIN: HCWS818 I would like to update the House that the UK Government has accepted the amendments to the International Health Regulations (2005) (IHR) which were agreed by countries at the World Health Assembly (WHA) on 1 June 2024.The IHRs …

14 Jul 2025 | Announcement Department of Health and Social Care linked

International Health Regulations amendments

UIN: HLWS818 My hon. Friend the Parliamentary Under-Secretary of State for Public Health and Prevention (Ashley Dalton MP) made the following Statement:I would like to update the House that the UK Government has accepted the amendments to the International Health …

2024

18 events
12 Dec 2024 | Announcement Department of Health and Social Care linked

Clinical Trials Regulations

UIN: HCWS310 My noble friend the Parliamentary Under-Secretary of State for Patient Safety, Women's Health and Mental Health (Baroness Merron) has made the following Written StatementI am pleased to announce that the Medicines for Human Use (Clinical Trials) (Amendmen...

12 Dec 2024 | Announcement Department of Health and Social Care linked

Clinical Trials Regulations

UIN: HLWS306 I am pleased to announce that the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 have been laid before Parliament today. When approved by Parliament, this legislation will represent the most significant reform of UK clinical trials...

2 Dec 2024 | Written question Department of Health and Social Care linked

Analgesics

To ask the Secretary of State for Health and Social Care, what his policy is on (a) doctors and (b) other qualified medical personnel administering pain-relieving drugs which may shorten lives; and whether regulations on that issue changed after the …

26 Nov 2024 | Written question Department of Health and Social Care linked

Tranexamic Acid

To ask the Secretary of State for Health and Social Care, what assessment he has made of the potential merits of making Tranexamic Acid (TXA) a Schedule 19 Drug. Answer: Discussions on the administration of tranexamic acid (TXA) formed part …

22 Oct 2024 | Announcement Department of Health and Social Care linked

Point of Care Medicines Manufacture Regulations

UIN: HCWS152 I am pleased to announce that the draft Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2024 were laid before Parliament yesterday. When approved by Parliament, this instrument will create a new regulatory framework for inn...

22 Oct 2024 | Announcement Department of Health and Social Care linked

Point of Care Medicines Manufacture Regulations

UIN: HLWS149 My Hon. Friend the Minister of State for Health (Secondary Care) (Karin Smyth MP) has made the following Written Statement: I am pleased to announce that the draft Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations …

15 May 2024 | Announcement Department of Health and Social Care linked

Update of Gamete Donation Regulations

UIN: HCWS467 In a parliamentary debate on 23 October 2023, I announced the Government’s intention to update the UK’s gamete donation regulations. The first change would allow people living with HIV with an undetectable viral load to donate their gametes. …

25 Apr 2024 | Consultation outcome Department of Health and Social Care linked

Amending references to PHE and HSCB in the Human Medicines Regulations — outcome published

We are seeking views about making amendments to references to Public Health England and the Regional Health and Social Care Board within the Human Medicines Regulations 2012.

28 Mar 2024 | Consultation outcome Department of Health and Social Care linked

Proposal for the use of patient group directions by pharmacy technicians — outcome published

This consultation will inform the government’s proposal to enable pharmacy technicians to supply and administer medicines using patient group directions.

29 Feb 2024 | Consultation outcome Department of Health and Social Care linked

Pharmacy supervision — consultation closed

DHSC is seeking views on proposals to modernise legislation governing the supervision of activities by a pharmacist in a pharmacy.

22 Feb 2024 | Consultation outcome Department of Health and Social Care linked

Amending references to PHE and HSCB in the Human Medicines Regulations — consultation closed

We are seeking views about making amendments to references to Public Health England and the Regional Health and Social Care Board within the Human Medicines Regulations 2012.

25 Jan 2024 | Consultation outcome Department of Health and Social Care linked

Amending references to PHE and HSCB in the Human Medicines Regulations — consultation opened

We are seeking views about making amendments to references to Public Health England and the Regional Health and Social Care Board within the Human Medicines Regulations 2012.

2023

17 events
21 Dec 2023 | Consultation outcome Medicines and Healthcare products Regulatory Agency linked

Consultation on end to the European Commission Decision Reliance Procedure — outcome published

This is a consultation on a statutory instrument to amend the Human Medicines Regulations 2012 to remove the provision which provides the legal basis to the European Commission Decision Reliance Procedure (ECDRP).

7 Dec 2023 | Consultation outcome Department of Health and Social Care linked

Pharmacy supervision — consultation opened

DHSC is seeking views on proposals to modernise legislation governing the supervision of activities by a pharmacist in a pharmacy.

29 Sep 2023 | Consultation outcome Department of Health and Social Care linked

Proposal for the use of patient group directions by pharmacy technicians — consultation closed

This consultation will inform the government’s proposal to enable pharmacy technicians to supply and administer medicines using patient group directions.

27 Sep 2023 | Consultation outcome Medicines and Healthcare products Regulatory Agency linked

Consultation on end to the European Commission Decision Reliance Procedure — consultation closed

This is a consultation on a statutory instrument to amend the Human Medicines Regulations 2012 to remove the provision which provides the legal basis to the European Commission Decision Reliance Procedure (ECDRP).

30 Aug 2023 | Consultation outcome Medicines and Healthcare products Regulatory Agency linked

Consultation on end to the European Commission Decision Reliance Procedure — consultation opened

This is a consultation on a statutory instrument to amend the Human Medicines Regulations 2012 to remove the provision which provides the legal basis to the European Commission Decision Reliance Procedure (ECDRP).

18 Aug 2023 | Consultation outcome Department of Health and Social Care linked

Proposal for the use of patient group directions by pharmacy technicians — consultation opened

This consultation will inform the government’s proposal to enable pharmacy technicians to supply and administer medicines using patient group directions.

19 Mar 2023 | Consultation outcome Department of Health and Social Care Medicines and Healthcare products Regulatory Agency linked

Original pack dispensing and supply of medicines containing sodium valproate — outcome published

Public consultation on proposals to allow pharmacists to dispense prescription medicines in original packaging, in particular those containing sodium valproate.

9 Jan 2023 | Announcement Department of Health and Social Care linked

BioNTech Strategic Partnership

UIN: HLWS476 My Rt Hon Friend the Secretary of State for Health and Social Care (Steve Barclay) has made the following written statement: The UK’s response to the COVID-19 pandemic demonstrated the power of Government collaborating with industry to accelerate …

9 Jan 2023 | Announcement Department of Health and Social Care linked

Moderna Strategic Partnership

UIN: HLWS475 My Rt Hon Friend the Secretary of State for Health and Social Care (Steve Barclay) has made the following written statement: The COVID-19 pandemic has shown the importance of having the ability to develop and deploy vaccines rapidly …

2022

16 events
22 Jun 2022 | Announcement Department of Health and Social Care linked

UK Life Sciences

UIN: HLWS129 My Rt Hon Friend the Secretary of State for Health and Social Care (Sajid Javid) has made the following written statement:The life sciences have played an essential role in helping us to learn to live with COVID-19. The …

25 Jan 2022 | Consultation outcome Department of Health and Social Care linked

Review of temporary provisions in the Human Medicines Regulations 2012 to support influenza and COVID-19 vaccination campaigns — outcome published

We would like your views on a review of temporary provisions in the Human Medicines Regulations to support influenza and COVID-19 vaccination campaigns.

2021

11 events
29 Dec 2021 | Consultation outcome Department of Health and Social Care linked

Review of temporary provisions in the Human Medicines Regulations 2012 to support influenza and COVID-19 vaccination campaigns — consultation closed

We would like your views on a review of temporary provisions in the Human Medicines Regulations to support influenza and COVID-19 vaccination campaigns.

16 Dec 2021 | Announcement Department of Health and Social Care linked

Medicines Update

UIN: HCWS507 Under the Northern Ireland Protocol (NIP), medicines moving from GB to NI are required to comply with the EU Pharmaceutical Acquis. This creates a number of additional and duplicative regulatory barriers which risk the continuity of supply for …

16 Dec 2021 | Announcement Department of Health and Social Care linked

Medicines Update

UIN: HLWS494 My Hon Friend the Minister of State for Health (Edward Argar) has made the following statement:Under the Northern Ireland Protocol (NIP), medicines moving from GB to NI are required to comply with the EU Pharmaceutical Acquis. This creates …

13 Dec 2021 | Consultation outcome Department of Health and Social Care Medicines and Healthcare products Regulatory Agency linked

Original pack dispensing and supply of medicines containing sodium valproate — consultation closed

Public consultation on proposals to allow pharmacists to dispense prescription medicines in original packaging, in particular those containing sodium valproate.

8 Dec 2021 | Consultation outcome Department of Health and Social Care linked

Review of temporary provisions in the Human Medicines Regulations 2012 to support influenza and COVID-19 vaccination campaigns — consultation opened

We would like your views on a review of temporary provisions in the Human Medicines Regulations to support influenza and COVID-19 vaccination campaigns.

1 Nov 2021 | Consultation outcome Department of Health and Social Care Medicines and Healthcare products Regulatory Agency linked

Original pack dispensing and supply of medicines containing sodium valproate — consultation opened

Public consultation on proposals to allow pharmacists to dispense prescription medicines in original packaging, in particular those containing sodium valproate.

2020

5 events

2019

1 event

2018

7 events
24 Dec 2018 | Consultation outcome Medicines and Healthcare products Regulatory Agency linked

Implementing ‘safety features’ under the Falsified Medicines Directive — outcome published

This consultation invites views on the proposed steps we intend to take to make sure the UK meets its obligations to transpose the 'safety features' provisions of the Falsified Medicines Directive (FMD).

23 Sep 2018 | Consultation outcome Medicines and Healthcare products Regulatory Agency linked

Implementing ‘safety features’ under the Falsified Medicines Directive — consultation closed

This consultation invites views on the proposed steps we intend to take to make sure the UK meets its obligations to transpose the 'safety features' provisions of the Falsified Medicines Directive (FMD).

16 Jul 2018 | Consultation outcome Medicines and Healthcare products Regulatory Agency linked

Implementing ‘safety features’ under the Falsified Medicines Directive — consultation opened

This consultation invites views on the proposed steps we intend to take to make sure the UK meets its obligations to transpose the 'safety features' provisions of the Falsified Medicines Directive (FMD).

2017

4 events
5 Dec 2017 | Consultation outcome Medicines and Healthcare products Regulatory Agency linked

Post-implementation Review of the Human Medicines Regulations 2012 (MLX 391) — outcome published

We are reviewing the impact of the Human Medicines Regulations 2012 (‘the 2012 Regulations’). This is part of a wider exercise within government to test the impact of legislation five years after implementation.

6 Jul 2017 | Consultation outcome Medicines and Healthcare products Regulatory Agency linked

Post-implementation Review of the Human Medicines Regulations 2012 (MLX 391) — consultation closed

We are reviewing the impact of the Human Medicines Regulations 2012 (‘the 2012 Regulations’). This is part of a wider exercise within government to test the impact of legislation five years after implementation.

15 Jun 2017 | Consultation outcome Medicines and Healthcare products Regulatory Agency linked

Post-implementation Review of the Human Medicines Regulations 2012 (MLX 391) — consultation opened

We are reviewing the impact of the Human Medicines Regulations 2012 (‘the 2012 Regulations’). This is part of a wider exercise within government to test the impact of legislation five years after implementation.

2016

3 events

2015

9 events
23 Jan 2015 | Consultation outcome Department of Health and Social Care Medicines and Healthcare products Regulatory Agency linked

Amendments to the Human Medicines Regulations 2012 — outcome published

Seeks views on proposals to amend the Human Medicines Regulations 2012 so that PHE can develop and authorise Patient Group Directions.

2014

6 events
31 Oct 2014 | Consultation outcome Department of Health and Social Care Medicines and Healthcare products Regulatory Agency linked

Amendments to the Human Medicines Regulations 2012 — consultation closed

Seeks views on proposals to amend the Human Medicines Regulations 2012 so that PHE can develop and authorise Patient Group Directions.

22 Sep 2014 | Consultation outcome Department of Health and Social Care Medicines and Healthcare products Regulatory Agency linked

Amendments to the Human Medicines Regulations 2012 — consultation opened

Seeks views on proposals to amend the Human Medicines Regulations 2012 so that PHE can develop and authorise Patient Group Directions.

22 Jul 2014 | Consultation (closed) Medicines and Healthcare products Regulatory Agency linked

Allowing paramedics involved in helicopter search and rescue operations to administer medicines — consultation closed

This consultation welcomes views on proposals to allow paramedics involved in maritime and coastguard agency contracted helicopter search and rescue operations to use medicines under patient group directions.

2 Jun 2014 | Consultation (closed) Medicines and Healthcare products Regulatory Agency linked

Allowing paramedics involved in helicopter search and rescue operations to administer medicines — consultation opened

This consultation welcomes views on proposals to allow paramedics involved in maritime and coastguard agency contracted helicopter search and rescue operations to use medicines under patient group directions.

2013

3 events
25 Oct 2013 | Bill stage linked

Medicinal Labelling Bill [HL]

Second Reading 11:22:00 Moved by Lord Winston: That the Bill be read a second time. Lord Winston (Lab): My Lords, first, I am so pleased to see the noble Baroness sitting on the Front Bench, but so sad that the …

13 May 2013 | Bill stage linked

Medicinal Labelling Bill [HL]

First Reading 15:07:00 A Bill to require the declaration relating to animal research to be placed on medicinal products’ labels. The Bill was introduced by Lord Winston, read a first time and ordered to be printed.