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Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
An overview of the process to get a marketing authorisation (MA), including submitting, fast-tracking an application, naming your medicine and paying fees.
Details of the organisations that are currently approved to undertake conformity assessments on medical devices.
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 MHRA, the process for getting advice and the fees involved.
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.
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
Who can supply or administer medicines to patients without a doctor under a PGD, which medicines they can supply, and legal requirements for PGDs.
How the MHRA processes variations to medicines' marketing authorisations for the UK and Northern Ireland.
Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
The process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
Detailed guidance on advertising and promoting medicines.
How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
There are changes to the legislation on reference medicinal products (RMPs) used to support abridged marketing authorisation applications.
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
An overview of the systems and processes DHSC and NHS England use for responding to medicine shortages.
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