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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.
An overview of the process including submitting or fast-tracking an application, naming your medicine and paying fees.
Guidance for the pharmaceutical industry on how to apply to vary a veterinary Marketing Authorisation (MA) or Homeopathic Remedy.
How to renew marketing authorisations for products granted through different routes and at different times.
How the MHRA processes variations to Marketing Authorisations (MAs)
Guidance for the pharmaceutical industry on how to apply for an authorisation to place a veterinary medicine on the UK market or part of, or to expire one.
The seeds which must be certified before you can market them, how to get them certified and how to get a licence for your seed business.
Guidance for holders of Marketing Authorisations approved in Northern Ireland or the EU/EEA member states who want to bring a product to market in Great Britain.
How the MHRA assesses Marketing Authorisation Applications (MAA) for medicines referred under Article 29.
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.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
The CMA is investigating whether Google might have abused a dominant position through its conduct in ad tech
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