Secondary Legislation under Medicines and Medical Devices Act 2021

Showing 21 Statutory Instruments linked to this bill.

Human Medicines (Amendment) Regulations 2026

Laid before Parliament: 29 January 2026
Procedure: Draft affirmative
Parliament Page Legislation Text
Enabling Acts
Medicines and Medical Devices Act 2021
SI explanatory text 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.

Medical Devices (Fees Amendment) Regulations 2026

Laid before Parliament: 16 December 2025
Procedure: Draft affirmative
Parliament Page Legislation Text
Enabling Acts
European Union (Withdrawal) Act 2018 Medicines and Medical Devices Act 2021
SI explanatory text These Regulations make amendments to the Medical Devices Regulations 2002 (“the 2002 Regulations”) and the Medical Devices (Northern Ireland Protocol) Regulations 2021 (“the 2021 Regulations”).

Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025

Laid before Parliament: 29 April 2025
Procedure: Draft affirmative
Parliament Page Legislation Text
Enabling Acts
Medicines and Medical Devices Act 2021
SI explanatory text These Regulations amend the Human Medicines Regulations 2012 (“the 2012 Regulations”), which govern the arrangements throughout the United Kingdom for the licensing, manufacture, marketing, wholesale dealing and the sale and supply of medicines for human use. They also amend the Medicines Act 1968 (“the 1968 Act”).

Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025

Laid before Parliament: 3 April 2025
Procedure: Draft affirmative
Parliament Page Legislation Text
Enabling Acts
European Union (Withdrawal) Act 2018 Medicines and Medical Devices Act 2021
SI explanatory text These Regulations make amendments to the Medical Devices Regulations 2002 (“the 2002 Regulations”), the Blood Safety and Quality Regulations 2005 (“the 2005 Regulations”) and the Medical Devices (Northern Ireland Protocol) Regulations 2021 (“the 2021 Regulations”).

Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025

Reference: 2025 No. 317
Laid before Parliament: 11 March 2025
Procedure: Made negative
Parliament Page Legislation Text
Enabling Acts
Medicines and Medical Devices Act 2021
SI explanatory text These Regulations make amendments to the Medicines (Products for Human Use) (Fees) Regulations 2016 (S.I. 2016/190).

Medical Devices (Amendment) (Great Britain) Regulations 2025

Laid before Parliament: 3 March 2025
Procedure: Draft affirmative
Parliament Page Legislation Text
Enabling Acts
Medicines and Medical Devices Act 2021
SI explanatory text These Regulations amend the Medical Devices Regulations 2002 (S.I. 2002/618) (“the 2002 Regulations”) by removing the 25th and 26th May 2025 revocation dates of the following pieces of assimilated EU law:

Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024

Laid before Parliament: 12 December 2024
Procedure: Draft affirmative
Parliament Page Legislation Text
Enabling Acts
Medicines and Medical Devices Act 2021
SI explanatory text These Regulations amend the Medicines for Human Use (Clinical Trials) Regulations 2004 (“the 2004 Regulations”) which implement Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products in humans.

Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2024

Laid before Parliament: 21 October 2024
Procedure: Draft affirmative
Parliament Page Legislation Text
Enabling Acts
Medicines and Medical Devices Act 2021
SI explanatory text These Regulations amend the Human Medicines Regulations 2012 (S.I. 2012/1916) (“HMRs”) and the Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031) (“CTRs”). These Regulations make provision for medicinal products that are manufactured in a modular unit, to enable deployment from that site. This is known as modular manufacture (“MM”) and the products are referred to as “MM medicinal products”. The Regulations also make provision in relation to the manufacture and supply of medicines that are innovative and have particular characteristics such as a very short shelf life, or that are highly personalised to the recipient. These characteristics mean that the medicines have to be manufactured very close to the place where they are administered. The type of manufacture is known as point of care (“POC”) and the products are referred to in the Regulations as “POC medicinal products”.

Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024

Laid before Parliament: 21 October 2024
Procedure: Draft affirmative
Parliament Page Legislation Text
Enabling Acts
Medicines and Medical Devices Act 2021
SI explanatory text These Regulations amend the Medical Devices Regulations 2002 (S.I. 2002/618) (“the 2002 Regulations”) to insert new post-market surveillance requirements. The 2002 Regulations were made under section 2(2) of the European Communities Act 1972 to implement Directives 90/385/EEC, 93/42/EEC and 98/79/EC.

Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024

Laid before Parliament: 29 July 2024
Procedure: Draft affirmative
Parliament Page Legislation Text
Enabling Acts
Medicines and Medical Devices Act 2021
SI explanatory text 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.

Human Medicines (Amendments relating to Registered Dental Hygienists, Registered Dental Therapists and Registered Pharmacy Technicians) Regulations 2024

Laid before Parliament: 29 April 2024
Procedure: Draft affirmative
Parliament Page Legislation Text
Enabling Acts
Medicines and Medical Devices Act 2021
SI explanatory text These Regulations amend the Human Medicines Regulations 2012 (S.I. 2012/1916) (“HMRs”) which govern the arrangements across the United Kingdom for the licensing, manufacture, wholesale dealing and sale or supply of medicines for human use. The amendments extend to the whole of the United Kingdom.

Veterinary Medicines (Amendment etc.) Regulations 2024

Laid before Parliament: 4 March 2024
Procedure: Draft affirmative
Parliament Page Legislation Text
Enabling Acts
Medicines and Medical Devices Act 2021
SI explanatory text These Regulations amend the Veterinary Medicines Regulations 2013 (S.I. 2013/2033, “the 2013 Regulations”) in respect of Great Britain only.

Human Medicines (Amendments Relating to Coronavirus and Influenza) (England and Wales and Scotland) Regulations 2024

Laid before Parliament: 10 January 2024
Procedure: Draft affirmative
Parliament Page Legislation Text
Enabling Acts
Medicines and Medical Devices Act 2021
SI explanatory text 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 England and Wales and Scotland only.

Human Medicines (Amendment Relating to Original Pack Dispensing) (England and Wales and Scotland) Regulations 2023

Laid before Parliament: 29 June 2023
Procedure: Draft affirmative
Parliament Page Legislation Text
Enabling Acts
Medicines and Medical Devices Act 2021
SI explanatory text These Regulations amend the Human Medicines Regulations 2012 (S.I. 2012/1916) (“HMRs”) which govern the arrangements across the United Kingdom for the licensing, manufacture, wholesale dealing and sale or supply of medicines for human use. The amendments extend to England and Wales and Scotland only and create new dispensing provisions for prescription only medicines. Regulation 214(1) of the HMRs requires prescription only medicines to be sold or supplied in accordance with a prescription given by an appropriate practitioner, subject to exceptions contained in Chapter 3 (exemptions) of Part 12 (Dealings with medicinal products).

Medical Devices (Amendment) (Great Britain) Regulations 2023

Laid before Parliament: 27 April 2023
Procedure: Draft affirmative
Parliament Page Legislation Text
Enabling Acts
Medicines and Medical Devices Act 2021
SI explanatory text These Regulations amend the Medical Devices Regulations 2002 (S.I 2002/618) (“the 2002 Regulations”) to extend the periods for which certain medical devices that comply with EU legislation can be placed on the market in Great Britain. The 2002 Regulations were made under section 2(2) of the European Communities Act 1972, the Consumer Protection Act 1987 and the Finance Act 1973, and implemented Directive 90/385/EEC, Directive 93/42/EEC and Directive 98/79/EC.

Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023

Reference: 2023 No. 314
Laid before Parliament: 10 March 2023
Procedure: Made negative
Parliament Page Legislation Text
Enabling Acts
Medicines and Medical Devices Act 2021
SI explanatory text These Regulations make amendments to the Medicines (Products for Human Use) (Fees) Regulations 2016 (S.I. 2016/190).

Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023

Laid before Parliament: 6 February 2023
Procedure: Draft affirmative
Parliament Page Legislation Text
Enabling Acts
Medicines and Medical Devices Act 2021
SI explanatory text These Regulations make amendments to the Medical Devices Regulations 2002 (“the 2002 Regulations”), the Blood Safety and Quality Regulations 2005 (“the 2005 Regulations”) and the Medical Devices (Northern Ireland Protocol) Regulations 2021 (“the 2021 Regulations”). They also revoke and restate the Medical Devices (Consultation Requirements) (Fees) Regulations 1995 (“the 1995 Regulations”).

Commissioner for Patient Safety (Appointment and Operation) (England) Regulations 2022

Laid before Parliament: 7 February 2022
Procedure: Draft affirmative
Parliament Page Legislation Text
Enabling Acts
Medicines and Medical Devices Act 2021
SI explanatory text These Regulations make provision about the appointment and operation of the Commissioner for Patient Safety (the “Commissioner”) established under the Medicines and Medical Devices Act 2021 (c. 3).

Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022

Laid before Parliament: 7 February 2022
Procedure: Draft affirmative
Parliament Page Legislation Text
Enabling Acts
Medicines and Medical Devices Act 2021
SI explanatory text 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, and the Medicines for Human Use (Clinical Trials) Regulations 2004 (“the 2004 Regulations”), which govern the conduct of clinical trials of medicinal products for human use. The amendments make provision for the establishment and operation of the statutory version of the Early Access to Medicine Scheme (EAMS) – there has previously been a non-statutory version of the Scheme. The EAMS has the purpose of giving patients with life threatening or seriously debilitating conditions access to medicinal products that are either not authorised or not authorised for that use.

Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2022

Laid before Parliament: 7 February 2022
Procedure: Draft affirmative
Parliament Page Legislation Text
Enabling Acts
Medicines and Medical Devices Act 2021
SI explanatory text 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 human medicines for human use. The provisions in the 2012 Regulations to which the Note refers are presently due to cease to have effect on 1st April 2022.

Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021

Laid before Parliament: 17 June 2021
Procedure: Draft affirmative
Parliament Page Legislation Text
Enabling Acts
Medicines and Medical Devices Act 2021
SI explanatory text These Regulations amend the Medical Devices Regulations 2002 (S.I. 2002/618), to require that coronavirus test devices must be approved by the Secretary of State, before they are placed on market or put into service. They specify the application procedure for approval, and the performance requirements that such devices must meet for the purposes of approval. They also provide for exemptions from that procedure for public service use and provide that the Secretary of State must establish a register of approved coronavirus test devices. There are transitional provisions in respect of devices placed on the market before 31st October 2021. Regulation 10 requires the Regulations to be reviewed, and a report published on or before 31st December 2022.