We use some essential cookies to make this website work.
We鈥檇 like to set additional cookies to understand how you use 天美影院, 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
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
An overview of the process including submitting or fast-tracking an application, naming your medicine and paying fees.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
A list of individual human medicinal products under the new arrangements coming into effect on 1 January 2025 following agreement of the Windsor Framework.
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'
A summary of the types of scientific advice available at the鈥疢HRA, the process for getting advice and the fees involved.
The process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
Pharmacy (P), prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
Information on comparator products used in studies supporting abridged marketing authorisation application.
Detailed guidance on advertising and promoting medicines.
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
How the MHRA processes variations to marketing authorisations.
Who can supply and or administer specific medicines to patients without a doctor under a PGD and which medicines can be administered.
There are changes to the legislation on reference medicinal products (RMPs) used to support abridged marketing authorisation applications.
Details of the organisations that are currently approved to undertake conformity assessments on medical devices.
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
How to change the ownership from one marketing authorisation (MA) holder to another.
Don鈥檛 include personal or financial information like your National Insurance number or credit card details.
To help us improve 天美影院, we鈥檇 like to know more about your visit today. .