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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.
A summary of the types of scientific advice available at the MHRA, 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.
A pathway summarising the processes pharmaceutical companies should follow when preparing to launch new products in the UK.
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.
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
The process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
Detailed guidance on advertising and promoting medicines.
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.
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.
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
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