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Submission dates and how the submissions using the EC decision reliance procedure work.
An overview of the process including submitting or fast-tracking an application, naming your medicine and paying fees.
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
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.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
Guidance for UK companies on winning business from international aid and development projects.
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.
How the MHRA processes variations to Marketing Authorisations (MAs)
Guidance and how to submit your Production and Marketing Plan (PMP).
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
Guidance on Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice
If you're advertising or marketing, including direct marketing, you must be accurate and honest and follow the advertising codes of practice
The Lambert toolkit is for universities and companies that wish to undertake collaborative research projects with each other.
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