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
Webinars for pharmaceutical companies, clinical trial sponsors, e-cigarette producers and brokers of medicinal products
Guidance on how to submit changes to labelling and patient information leaflets to MHRA.
How to use PharmaQC to access pharmaceutical suppliers, Quality Control (QC) pharmacists and Commercial Medicines Unit (CMU) buyers.
A document for patients explaining how the highest risk patient groups eligible for new coronavirus treatments will be identified.
Guidance on infant and follow-on formula, the application form for infant and follow-on formula made from protein hydrolysates, and forms to notify the authority.
Approved countries for batch testing and importation of medicines
The Medicines and Healthcare products Regulatory Agency (MHRA) have embarked upon an ambitious programme of reform to ensure that medical device regulation is fit for purpose for software, including artificial intelligence (…
An overview of the legal requirements for children’s medicines that Marketing Authorisation Holders (MAHs) need to abide by.
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
This Statutory Instrument makes the necessary legislative amendments to update the statute book by removing references to the revoked Annex VIII of GB Classification, Labelling and Packaging of Substances and Mixtures Regula…
Apply for and maintain registrations for the brokering of human medicines.
This toolkit is for Innovation Passport holders following the Innovative Licensing and Access Pathway (ILAP) and provides activities to support the design and development of medicines.
Reporting, investigating and recalling suspected defective medicinal products to the Defective Medicines Report Centre (DMRC).
Guidance on defining intended purpose for Software as a Medical Device (SaMD), to help SaMD manufacturers in meeting their statutory obligations.
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
The MHRA have implemented a dual strategy for a risk-adapted approach to clinical trials in the UK.
Points to consider when using real-world data in clinical studies
Anyone in Northern Ireland selling medicines to the public via a website must still comply with the requirement to apply the EU common logo.
Use the rolling review route when you want to submit your eCTD dossier in separate parts for pre-assessment instead of making a full consolidated document submission.
Information and advice on submitting a nutritional product to the Advisory Committee for Borderline Substances (ACBS).
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).