Guidance and regulation

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

Code of practice on the effective prevention and control of infection by health service providers.

• From: Department of Health and Social Care
• Updated: 13 December 2022

• Health and Social Care Act 2008: code of practice on the prevention and control of infections and related guidance

  Executive summary Good infection prevention and control (IPC), including…

Guidance on managing and using bed rails safely.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 30 August 2023

Sets out standards required for NHS organisations concerning patient confidentiality.

• From: Department of Health and Social Care
• Updated: 7 November 2003

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

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

How to apply for, update and cancel licences for the manufacture, import and wholesale of human and veterinary medicines.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 25 March 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

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

UK companies who have their licence to manufacture or wholesale medicines terminated and cancelled.

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

Guidance on manufacturing, importing, distributing and supplying specially manufactured or ordered products, including cannabis-based products for medicinal use in humans (CBPMs), known as 'specials'

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 12 May 2023

Information on when software applications are considered to be a medical device and how they are regulated.

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

Who can supply and or administer specific medicines to patients without a doctor under a PGD and which medicines can be administered.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 4 December 2017

How mental health practitioners can manage risk including self-harm and harm to others.

• From: Department of Health and Social Care
• Updated: 31 March 2009

How to apply for a traditional herbal registration (THR) to market a herbal medicine in the UK.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 5 January 2024

Guidance for UK wholesalers and manufacturers on how to import human medicines including unlicensed medicines, how to apply for a licence and how much it costs.

• From: Department of Health and Social Care and 1 others
• Updated: 31 December 2020

How to respond to individuals at risk of developing pressure ulcers, prevent harm where they occur and raise a safeguarding concern.

• From: Department of Health and Social Care
• Updated: 5 March 2024

How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 8 October 2019

How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 25 March 2022

Guidance on out of specification investigations, including definitions and laboratory analysis and phase I,II and III investigations.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 26 February 2018