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Guidance on whether or not your product is a medical device.
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…
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
Details of how Marketing Authorisation Holders can provide information on planned or potential future submissions, to the MHRA.
How to renew marketing authorisations for products granted through different routes and at different times.
Use the rolling review route when you want to submit your eCTD dossier in separate parts for pre-assessment instead of making a full consolidated document submission.
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations.
How the MHRA assesses Marketing Authorisation Applications (MAA) for medicines referred under Article 29.
How to distinguish between products that are regulated as medical devices and those regulated as medicinal products.
An overview of the legal requirements for children’s medicines that Marketing Authorisation Holders (MAHs) need to abide by.
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
How and when to register updated packaging and information leaflets when new national marketing authorisations have been issued
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…
The way you apply to licence biological products has changed
How traditional herbal medicines and homeopathic medicines will be treated by the MHRA.
Industry must notify the MHRA if they will not be using these flexibilities
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.
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