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Submission dates and how the submissions using the EC decision reliance procedure work.
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 for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
Information and guidance on a range of medical devices for users and patients.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (11 March 2024) approved the medicine etrasimod (Velsipity) to treat people with moderately to severely active ulcerative colitis.
A wholesale dealer in Great Britain may import Qualified Person certified medicines from the European Economic Area if certain checks are made by the ‘Responsible Person (import)’
Submissions related to human medicines need to be submitted directly to the MHRA.
The New Active Substance Work Sharing Initiative (NASWSI) has successfully approved several medicines through this international collaboration and continues to foster cooperation and strong relationships between its Access partners. The Biosimilar Work Sharing Initiative (BSWSI) builds on this success.
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.
There is a risk of harmful drug interactions with the ritonavir component of the COVID-19 treatment Paxlovid▼ due to its inhibition of the enzyme CYP3A, which metabolises many commonly used drugs. Prescribers should obtain a detailed patient history of current...
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
There have been very rare reports of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) with pseudoephedrine.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (11 March 2024) approved the medicine quizartinib (Vanflyta) to be used alongside chemotherapy as first line treatment for adults who have acute myeloid leukaemia (AML).
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Information about how to register your homeopathic medicinal product through the Simplified Homeopathic Registration Scheme or the UK Homeopathic National Rules Scheme
How to apply for marketing authorisation via this new procedure.
Pharmacovigilance system requirements
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