Last Thursday (19 October 2023) 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 provides an overview of the process including submitting or fast-tracking an application, naming your medicine and paying fees.
Their primary goal is to protect public health by rigorously evaluating and monitoring these products throughout their lifecycle. When it comes to medicines, the MHRA grants licenses that allow manufacturers or marketing authorization holders to bring their products to the UK market.
The recent update to the guidance is the addition of a 'Checklist and abstract for bioequivalence studies and/or biowaivers' and a 'Checklist for product information', for established active substance MAAs within scope.
To submit a national application for the UK and Great Britain (England, Scotland, and Wales), the MHRA Submissions Portal needs to be used. In addition, the applicant should also use the pre-submission checklist.
An application can be accelerated if the Department of Health and Social Care (DHSC) has determined that an essential medicine has a shortage of supply and that there is compelling evidence of benefit. 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)
Any submission that does not meet the requirements will be rejected and If a submission is rejected, MHRA will email the reasons for the rejection. The applicant must then resend the entire submission with the errors corrected.
Click this LINK to learn more about the requirements for licence to market a medicine in the UK.