Guidance and regulation

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: 20 March 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: 27 December 2020

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

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

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: 25 March 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

Importing investigational medicinal products for use in clinical trials

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

Sets out medicines that can be moved to Northern Ireland to meet patient need.

• From: Department of Health and Social Care
• Updated: 11 April 2024

What you need to do to supply authorised medicines from Great Britain to Northern Ireland.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 23 January 2023

Register as a manufacturer, importer or distributor of active substances.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 19 October 2022

Guidance on what approved bodies are, what they do and how you can become one.

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

An interpretation of the good manufacturing practice (GMP) requirements for specials manufacturers.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 25 February 2021

The actions to take for sourcing medicines in different circumstances.

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

Approved countries for batch testing and importation of medicines

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

Information for wholesale dealer licence holders about the medicines put on the UK market for UK patients that they cannot export or hoard.

• From: Department of Health and Social Care
• Updated: 28 June 2023

Reporting, investigating and recalling suspected defective medicinal products to the Defective Medicines Report Centre (DMRC).

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 2 August 2021

How a manufacturer can apply for approval to supply a non-compliant medical device on humanitarian grounds.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 30 December 2022

Apply for and maintain registrations for the brokering of human medicines.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 19 October 2022