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A step-by-step guide on using the MORE Platform for Submissions of device related incidents.
Details of how Marketing Authorisation Holders can provide information on planned or potential future submissions, to the MHRA.
A letter to community pharmacy contractors to set out the detail of the agreed funding arrangements for community pharmacy.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
Which professions can act as an investigator, training and experience expectations, provision of medical support and delegation of activities.
How to apply for an exceptional use authorisation to place medical devices on the UK market.
The MMRV vaccine will become part of the routine childhood immunisation schedule in the UK from 1 January 2026.
Guidance on how to complete your Electronic Application Form (eAF) and Cover Letter
Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.
A step-by-step guide on using the MORE Platform for Registrations for Submissions of device related incidents.
Information to help comply with ICH guidelines, if you are running clinical trials in the UK.
Information for patients, healthcare professionals and developers of new medicines
Information for clinicians and patients.
Guidelines to help mitigate and manage medicine shortages.
How to comply with the regulatory requirements for manufacturing custom-made medical devices.
Guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.
The MHRA accepts an Active Substance Master File and/or a Certificate of Suitability in both new national initial Marketing Authorisation Applications (MAA) and in Marketing Authorisation Variation (MAV) applications.
Documentation to support changes made to reporting Manufacturer Incident Reports (MIRs) and Field Safety Corrective Action Reports (FSCAs) to the MHRA following implementation of the Medical Devices (Post-market Surveillance…
Information about ensuring blood and blood component safety.
An interpretation of the good manufacturing practice (GMP) requirements for specials manufacturers.
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