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Medicines and Healthcare products Regulatory Agency

Medicines and Healthcare products Regulatory Agency

Services and information

Blood regulation and safety

Guidance on class 1 medical devices
MHRA fees
Medical devices: how to comply with the legal requirements
Make a payment to MHRA
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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
Notify MHRA about a clinical investigation for a medical device
MHRA fees
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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
Good laboratory practice (GLP) for safety tests on chemicals
MHRA fees
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Herbal and homeopathic medicines

Decide if your product is a medicine or a medical device
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

Good manufacturing practice and good distribution practice
Suspended and revoked licences for manufacturers and wholesalers of medicines
Apply for manufacturer or wholesaler of medicines licences
Licences to manufacture or wholesale medicines
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Marketing authorisations, variations and licensing guidance

Medicines: packaging, labelling and patient information leaflets
Marketing authorisations: lists of granted licences
Apply for a licence to market a medicine in the UK
Patient group directions (PGDs)
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Medical devices regulation and safety

Alerts and recalls for drugs and medical devices
Medical devices: conformity assessment and the CE mark
Decide if your product is a medicine or a medical device
Register as a manufacturer to sell medical devices
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Payment and fees

MHRA fees
Make a payment to MHRA

Vigilance, safety alerts and guidance

Alerts and recalls for drugs and medical devices
Drug Safety Update
Medicines: packaging, labelling and patient information leaflets
Send and receive information on adverse drug reactions (ADRs)
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