Medicines and Healthcare products Regulatory Agency

Services and information

Blood regulation and safety

• Medical devices: how to comply with the legal requirements in Great Britain
• MHRA fees
• Make a payment to MHRA
• Blood: authorisations and safety reporting
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Clinical trials and investigations

• Clinical trials for medicines: apply for authorisation in the UK
• Clinical trials for medicines: manage your authorisation, report safety issues
• Combined review to facilitate speedier set up for clinical research trials
• Notify the MHRA about a clinical investigation for a medical device
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Conferences and events

• Conferences and events
• Request a MHRA speaker at an event or conference

Good practice, inspections and enforcement

• Good manufacturing practice and good distribution practice
• Good clinical practice for clinical trials
• MHRA regulatory flexibilities resulting from coronavirus (COVID-19)
• Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF)
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Herbal and homeopathic medicines

• MHRA fees
• List of banned or restricted herbal ingredients for medicinal use
• Make a payment to MHRA
• Apply for a traditional herbal registration (THR)
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Licensing

• Medicines: reclassify your product

Manufacturing, wholesaling, importing and exporting medicines

• Suspended and revoked licences and registrations for manufacturers and wholesalers of medicines and ingredients
• Good manufacturing practice and good distribution practice
• Medicines that you cannot export from the UK or hoard
• Acting as a Responsible Person (import)
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Marketing authorisations, variations and licensing guidance

• One-dose Janssen COVID-19 vaccine approved by the MHRA
• The MHRA concludes positive safety profile for Pfizer/BioNTech vaccine in 12- to 15-year-olds
• Moderna vaccine becomes third COVID-19 vaccine approved by UK regulator
• Apply for a licence to market a medicine in the UK
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Medical devices regulation and safety

• Alerts, recalls and safety information: drugs and medical devices
• Regulating medical devices in the UK
• Register medical devices to place on the market
• Don’t rely on temperature screening products for detection of coronavirus (COVID-19), says MHRA
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Payment and fees

• MHRA fees

Scientific research and development

• Prime Minister kicks off major new science initiative at visit of MHRA’s National Institute for Biological Standards and Control

Vigilance, safety alerts and guidance

• Coronavirus (COVID-19) vaccine adverse reactions
• Alerts, recalls and safety information: drugs and medical devices
• Drug Safety Update
• MHRA issues new advice, concluding a possible link between COVID-19 Vaccine AstraZeneca and extremely rare, unlikely to occur blood clots
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