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Data, Freedom of Information releases and corporate reports
Guidance on out of specification investigations, including definitions and laboratory analysis and phase I,II and III investigations.
How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device.
How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
How the MHRA makes decisions on what is a medicinal product (borderline products).
How to change the ownership from one marketing authorisation (MA) holder to another.
Take care when using creams to treat dry skin conditions as they can easily dry onto clothing, bedding and bandages making them more flammable.
A list of herbal medicines currently holding a traditional herbal registration (THR) granted by the Medicines and Healthcare products Regulatory Agency (MHRA).
Information about when you need to submit substantial amendments to a clinical trial including changes to the trial sponsor or legal representative, Investigational medicinal product certification and importation.
Information and guidance on a range of medical devices for users and patients.
Information about the EU Regulations and their implementation in Northern Ireland
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
This guidance summarises our approach to pharmacovigilance
How to make a payment to MHRA by credit or debit card or a bank transfer.
The process for applicants applying for a Paediatric Investigation Plan (PIP) modification or waiver.
Guidance on the 150-day assessment timeline for high-quality marketing authorisation applications including information on how to apply.
How to get a marketing authorisation for an Advanced Therapy Medicinal Product (ATMP) so it can be sold and/or supplied in Great Britain.
Guidance explaining the main features of the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) in relation to in vitro diagnostic medical devices
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
This guidance sets out the legal framework for patient information leaflets as described in EU and national legislation and best practice in the area of information design.
Information on the implementation of labelling and packaging requirements for medicinal products for human use under the Windsor Framework.
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