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Outlining the principles for the management and oversight of the import of investigational medicinal products (IMPs) to Great Britain from listed countries.
A step-by-step guide on using the MORE Platform for Submissions of device related incidents.
How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
The Vaccine Development Evaluation Centre (VDEC) at Porton Down in Wiltshire facilitates the development and evaluation of new vaccines and therapeutics.
Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.
Comply with good pharmacovigilance practice and prepare for an inspection.
Information for healthcare professionals on how pulse oximeters are regulated, home use and issues to look out for when using the devices
How to register as a manufacturer, importer or distributor of active substances.
The MHRA provides advice for Retailers and Producers of e-cigarette / vape products.
How to renew marketing authorisations for products granted through different routes and at different times.
Information about the MHRA's duties and how you can report a non-compliant medical device.
Guidance on infant and follow-on formula, the application form for infant and follow-on formula made from protein hydrolysates, and forms to notify the authority.
A letter to community pharmacy contractors to set out the detail of the agreed funding arrangements for community pharmacy.
Guidance on how to complete your Electronic Application Form (eAF) and Cover Letter
Information on the new regulations for the post-market surveillance of medical devices which come into effect on 16 June 2025.
How to apply for an exceptional use authorisation to place medical devices on the UK market.
The review of the safety of isotretinoin has concluded.
Examples of what manufacturers must report to the MHRA under the medical device vigilance system when incidents involving their devices occur in the UK.
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
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