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An overview of the process including submitting or fast-tracking an application, naming your medicine and paying fees.
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
A summary of the types of scientific advice available at the鈥疢HRA, the process for getting advice and the fees involved.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
Pharmacy (P), prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
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'
Who can supply and or administer specific medicines to patients without a doctor under a PGD and which medicines can be administered.
Information on comparator products used in studies supporting abridged marketing authorisation application.
The process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
A pathway summarising the processes pharmaceutical companies should follow when preparing to launch new products in the UK.
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.
Detailed guidance on advertising and promoting medicines.
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
How the MHRA processes variations to marketing authorisations.
Guidance on applying for a Marketing Authorisation for Decentralised Manufacture, including eligibility, process, and requirements.
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.
How to get a marketing authorisation (MA) for an advanced therapy medicinal product (ATMP) so it can be sold and/or supplied in the United Kingdom.
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