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Detailed guidance, regulations and rules
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Consultations and strategy
Data, Freedom of Information releases and corporate reports
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.
Pharmacy (P), prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
A summary of the types of scientific advice available at the MHRA, the process for getting advice and the fees involved.
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'
Details of the organisations that are currently approved to undertake conformity assessments on medical devices.
The process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
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.
Information on comparator products used in studies supporting abridged marketing authorisation application.
How the MHRA processes variations to marketing authorisations.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
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.
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.
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
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