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
Screening Decisions
Check what processes are considered as insufficient production under the Trade and Cooperation Agreement.
Guidance for clinical trials that use Decentralised Manufactured Investigational Medicinal Products (IMPs).
UK guideline on GMP for decentralised manufacturing, ensuring compliance with EU GMP principles for safe, quality medicinal products.
Information on the new regulations for decentralised manufacture, including point of care and modular manufacture, which come into effect 23 July 2025.
Use the case studies to help you decide when your goods may (or may not) go beyond insufficient production.
MHRA’s mechanism for evaluating the justifications supplied by applicant organisations who plan to utilise decentralised manufacture.
For manufacturers and distributors of intermediate and final feedingstuffs containing a medicinal premix or specified feed additives in Great Britain and Northern Ireland.
Emerging techniques on how to prevent or minimise the environmental impacts of industrial hydrogen production from methane or refinery fuel gas with carbon capture for storage.
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).