Medicines and Healthcare products Regulatory Agency
gov.uk
Imported from official source
UK medicines and medical devices regulator; recalls and safety alerts.
Publications 67
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Opportunities for patients and the public to be involved in the work of the MHRA
How we engage and involve patients and the public in our regulatory decision-making.
Alert Safety -
Find product information about medicines
How to get information including patient information leaflets (PILs), details on how the medicine can be used (SPCs) and scientific reports (PARs).
Alert Safety -
Guidance: Medicines that you cannot export from the UK or hoard
Sets out medicines that cannot be exported from the UK or hoarded because they are needed for UK patients.
Alert Safety -
Decision: Human and veterinary medicines: register of licensed manufacturing sites
The MHRA register of licensed manufacturing sites: manufacturer specials - human (MS) and manufacturer specials authorisation - veterinary (MANSA) only.
Alert Safety -
Decision: Human medicines: register of licensed wholesale distribution sites
Department of Health and Social Care and MHRA register of licensed wholesale distribution sites (human).
Alert Safety -
Official Statistics: Quarterly reports on the import of unlicensed medicines
Details and statistics on the import of unlicensed medicines from March 2014 onwards.
Alert Safety -
Notice: Medicines: terminated and cancelled manufacturing and wholesale dealer licences
UK companies who have their licence to manufacture or wholesale medicines terminated and cancelled.
Alert Safety -
Decision: Medicines: new manufacturing and wholesale dealer licences
List of sites granted a manufacturer or wholesale dealer licence.
Alert Safety -
Advanced therapy medicinal products: regulation and licensing in UK
How to get a marketing authorisation (MA) for an advanced therapy medicinal product (ATMP) so it can be sold and/or supplied in the United Kingdom.
Alert Safety -
Apply for a licence to market a medicine in the UK
An overview of the process to get a marketing authorisation (MA), including submitting, fast-tracking an application, naming your medicine and paying fees.
Alert Safety -
Medicines: apply for a variation to your marketing authorisation
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
Alert Safety -
Clinical trials for medicines: Good clinical practice inspections
Information relating to good clinical practice (GCP) inspections.
Alert Safety -
Medicines: reclassify your product
Pharmacy (P), prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
Alert Safety -
Notice: Register of brokers authorised to deal in human medicines
Current listing of UK brokers authorised to broker human medicines, including company name, registration and address.
Alert Safety -
Decision: Suspended and revoked licences and registrations for manufacturers and wholesalers of medicines and ingredients
Public list of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked or suspended.
Alert Safety -
Send and receive information on adverse drug reactions (ADRs)
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
Alert Safety -
Guidance: Magnetic resonance imaging equipment in clinical use: safety guidelines
Relevant safety information for users of magnetic resonance imaging (MRI) equipment in clinical use.
Alert Safety