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The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations.
How to renew marketing authorisations for products granted through different routes and at different times.
Guidance on whether or not your product is a medical device.
Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
Guidance on what approved bodies are, what they do and how you can become one.
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
The Early Access to Medicines Scheme (EAMS) aims to give patients with life threatening or seriously debilitating conditions early access to medicines that show early signs of having a major advantage over existing therapeut…
An overview of the legal requirements for children’s medicines that Marketing Authorisation Holders (MAHs) need to abide by.
This toolkit is for Innovation Passport holders following the Innovative Licensing and Access Pathway (ILAP) and provides activities to support the design and development of medicines.
How a manufacturer can apply for approval to supply a non-compliant medical device on humanitarian grounds.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
The New Active Substance Work Sharing Initiative (NASWSI) has successfully approved several medicines through this international collaboration and continues to foster cooperation and strong relationships between its Access p…
How to distinguish between products that are regulated as medical devices and those regulated as medicinal products.
The way you apply to licence biological products has changed
How and when to register updated packaging and information leaflets when new national marketing authorisations have been issued
How traditional herbal medicines and homeopathic medicines will be treated by the MHRA.
Apply now to join the AI Airlock pilot by the MHRA. Benefit from industry and regulatory expert collaboration, bespoke testing plans, and improved regulatory understanding.
Information relating to the disapplication of falsified medicines under UK Law.
Industry must notify the MHRA if they will not be using these flexibilities
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