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

• New proposals for the future of UK clinical trial legislation
• Oral COVID-19 antiviral, Paxlovid, approved by UK regulator
• Consultation on proposals for legislative changes for clinical trials
• Clinical trials for medicines: apply for authorisation in the UK
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Conferences and events

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

Good practice, inspections and enforcement

• Pharmacovigilance inspection metrics, 2009 to present
• Good manufacturing practice and good distribution practice
• Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF)
• Good clinical practice for clinical trials
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Herbal and homeopathic medicines

• Apply for a traditional herbal registration (THR)
• MHRA fees
• Make a payment to MHRA
• List of banned or restricted herbal ingredients for medicinal use
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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: reclassify your product
• Acting as a Responsible Person (import)
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Marketing authorisations, variations and licensing guidance

• First oral antiviral for COVID-19, Lagevrio (molnupiravir), approved by MHRA
• One-dose Janssen COVID-19 vaccine approved by the MHRA
• Innovative Licensing and Access Pathway
• Medicines: packaging, labelling and patient information leaflets
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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
• How tests and testing kits for coronavirus (COVID-19) work
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Scientific research and development

• Innovative Licensing and Access Pathway (ILAP): New partner announcement
• 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) vaccines adverse reactions
• Alerts, recalls and safety information: drugs and medical devices
• Drug Safety Update
• Oral COVID-19 antiviral, Paxlovid, approved by UK regulator
• See more