Guidance and regulation

The MHRA have published a roadmap which outlines the intended timelines for delivering the future regulatory framework for medical devices.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 28 March 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

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

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

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

Guidance on the Ionising Radiation (Medical Exposure) Regulations 2017 for employers and health professionals who carry out medical radiological procedures.

• From: Department of Health and Social Care
• Updated: 27 June 2018

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

A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.

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

Pharmacovigilance system requirements

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 17 November 2023

How to conform with the legal requirements for placing medical devices on the market.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 31 December 2020

Guidance for pharmacists on prescriptions issued in EU countries, Norway, Iceland, Liechtenstein and Switzerland.

• From: Department of Health and Social Care
• Updated: 3 February 2021

Guidance on the 150-day assessment timeline for high-quality marketing authorisation applications including information on how to apply.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 16 April 2024

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

A wholesale dealer in Great Britain may import Qualified Person certified medicines from the European Economic Area if certain checks are made by the ‘Responsible Person (import)’

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 22 December 2021

You must get permission to export certain drugs and medicines.

• From: Home Office and 2 others
• Updated: 19 March 2024

Apply for a promising innovative medicine (PIM) designation or scientific opinion for your medicine from MHRA.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 18 April 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

UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 2 May 2024

How to use this new procedure for medicines licensing applications.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 8 April 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 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