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What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
How to get information including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
Guidance on the safe and effective use of GLP-1 medicines for weight loss and diabetes.
GLP-1 medicines and what they are used for Glucagon-like peptide-1…
How to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland.
Sets out medicines that cannot be exported from the UK or hoarded because they are needed for UK patients.
The Medicines and Healthcare Regulatory Agency have launched RegulatoryConnect, a service that provides the capability to track applications and view live authorisation details.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
How to manage and use bed rails safely.
An overview of the process including submitting or fast-tracking an application, naming your medicine and paying fees.
How to get access to MHRA submissions portals, how to use them, where to go for help.
How to apply for, update and cancel licences for the manufacture, import and wholesale of human and veterinary medicines.
This publication clarifies which regulatory guidelines should be followed, and which apply, in the development of phage therapeutic products.
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
UK companies who have their licence to manufacture or wholesale medicines terminated and cancelled.
How to contact the MHRA for specific services or enquiries.
How to show the MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Information about the reproductive risks of taking valproate medicines and the measures in place to reduce potential harm.
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