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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

8 events

2025

9 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.

2024

9 events
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

10 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.

2022

13 events
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

7 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.

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

2 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.