Guidance and regulation

What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 8 February 2024

Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 19 December 2019

Sets out medicines that cannot be exported from the UK or hoarded because they are needed for UK patients.

• From: Department of Health and Social Care and 1 others
• Updated: 8 May 2024

How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 11 January 2024

How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 9 May 2024

Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.

• From: Department of Health and Social Care and 1 others
• Updated: 13 May 2024

An overview of the process including submitting or fast-tracking an application, naming your medicine and paying fees.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 14 May 2024

Monthly PDF editions of the Drug Safety Update newsletter from MHRA and its independent advisor, the Commission on Human Medicines

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 29 April 2024

Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 10 April 2024

Details of the Yellow Card scheme, which is the system for recording adverse incidents with medicines and medical devices in the UK.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 1 January 2021

How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 10 April 2024

Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 26 March 2024

Consumer advice and details of how to report problems with e-cigarettes with guidance on how to place an e-cigarette on the market in Great Britain and Northern Ireland, including the notification scheme.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 2 November 2022

How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 26 April 2024

Safety leaflet on opioid medicines to help patients and their families reduce the risks of harm.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 3 August 2021

Submissions related to human medicines need to be submitted directly to the MHRA.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 4 May 2021

How to package medicines for sale and what information you must provide to consumers and healthcare professionals.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 7 March 2024

Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 22 April 2024

How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 6 April 2023

Information on MHRA's enforcement duties and how to report a non-compliant medical device.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 1 July 2023