We use some essential cookies to make this website work.
We’d like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services.
We also use cookies set by other sites to help us deliver content from their services.
You have accepted additional cookies. You can change your cookie settings at any time.
You have rejected additional cookies. You can change your cookie settings at any time.
Departments, agencies and public bodies
News stories, speeches, letters and notices
Detailed guidance, regulations and rules
Reports, analysis and official statistics
Consultations and strategy
Data, Freedom of Information releases and corporate reports
Apply for and maintain registrations for the brokering of human medicines.
This guide has been provided to reduce the burden when preparing responses to Post Inspection Letters.
Guidance on the steps manufacturers and suppliers can take to ease supply shortages.
Helping interpret the Human Medicines (Amendment) Modular Manufacture and Point of Care regulations 2025.
How manufacturers can apply for approval to supply a non-compliant medical device on humanitarian grounds.
Information relating to parallel imports and the implementation of the Windsor Framework.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
How and when to register updated packaging and information leaflets when new national marketing authorisations have been issued
The UK government has introduced the Northern Ireland MHRA Authorised Route (NIMAR). This new route for supply became operational 1 January 2022.
Information relating to the disapplication of falsified medicines under UK Law.
The EU has published guidance on exemptions for medical devices manufactured and used within EU health institutions, which applies to Northern Ireland-based health institutions, replacing interim guidance from the MHRA.
Guidance to help medicine manufacturers meet safe limits on levels of nitrosamine impurities in medicines.
What you need to do to supply investigational medicinal products (IMPs) from Great Britain to Northern Ireland.
How the ‘Written Confirmation’ process operates for active substances manufactured in Great Britain (England, Wales and Scotland).
summary
On this page the Medicines and Healthcare Products Regulatory agency provides advice for producers of E-cigarette/vape products
Guidance on moving medicines by air
Supplementary information for international regulators on packaging changes and the export of UK medicines.
A series of webinars providing guidance on the Windsor Framework agreement and the supply of medicines in Northern Ireland.
Qualified Persons (QPs) should follow the below guidance on the flexible approaches we are taking for medicines imported from third countries.
Don’t include personal or financial information like your National Insurance number or credit card details.
To help us improve GOV.UK, we’d like to know more about your visit today. Please fill in this survey (opens in a new tab and requires JavaScript).