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UK MHRA Guidance: Navigating on Applying for a Licence to Market a Medicine

Last Wednesday (28 February 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Apply for a licence to market a medicine in the UK" that gives an overview of the process including submitting or fast-tracking an application, naming your medicine and paying fees.

The recent update about new process changes that are being introduced for applications for  “Established Medicines". Bringing a new medicine to market is a complex process that requires careful navigation of regulatory requirements.

National applications for the UK and Great Britain (England, Scotland, and Wales) should be submitted through the MHRA Submissions Portal using the electronic Common Technical Document (eCTD) and the pre-submission checklist.

New process change guidance from 1 March 2024 to ensure applications are complete on initial assessment, or as soon after submission as possible.

An application can be fast tracked if convincing evidence of benefit exists in a public health emergency or if an essential medicine is in short supply, which has been verified by the Department of Health and Social Care (DHSC).

The letter should include:

  • the justification for fast-tracking

  • a brief description of the major clinical properties of the product

  • evidence supporting the claimed benefits of the product for the proposed indication(s)

Fees for submissions can be found on the MHRA fees guidance and can be calculated using the Fees Calculator. If a submission does not meet the requirements, it will be rejected. If a submission is rejected, the reasons for the rejection will be emailed and applicant must then re-submit the entire submission.

To know more about this guidance click this LINK.

Also, the MHRA updated the guidance on the Innovative Devices Access Pathway (IDAP), by Adding Data Protection and Privacy information and click this LINK to know about the updates.


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