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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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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 …

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...

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. …

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 …

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 …

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 …