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Detailed guidance, regulations and rules
Reports, analysis and official statistics
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Data, Freedom of Information releases and corporate reports
Guidance on the MHRA’s national assessment procedure for marketing authorisation applications.
Submit or respond to online applications for certain civil, family and tribunal cases.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
What happens if someone makes a money claim against you, saying you owe them money, and how you can respond or defend yourself
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Design, build and operate APIs in a consistent way
How residents can complain about a building safety risk, or the performance of an accountable person or principal accountable person.
A summary of what attending a review panel is like and the documents that you can submit to the Independent Review Mechanism (IRM).
How to use a before-and-after study to evaluate your digital health product.
Download MHRA's Request for Further Information (RFI) response template, with guidance on how to complete it.
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