We have been involved in several disputes between medicine manufacturers and distributors, including those which have at their centre an erroneous application to the UK regulator, the MHRA, for a marketing authorisation ("MA"). Before having an MA, an applicant must have a manufacturing authorisation ("MIA"), an expression used to include a licence to import products as well as 'manufacture' in its simpler form.
According to an update published earlier this month, the MHRA receives around 840 MIA related applications per year, of which around 30% are met with Requests for Further Information before the assessment proper can begin, which causes wasted time and costs for all involved.
Here is a summary of the MHRA’s 6 top tips to help reduce the number of applications they have to turn away. The full MHRA guidance is available here.
- Fill in the forms in full and attach all the relevant documents. It seems obvious but missing sections or failing to attach documents is a common mistake.
- Current capabilities - the MHRA assesses your current abilities, not what you aspire to, so ensure your current procedures, systems, equipment and expertise match what you are applying for.
- Key personnel need relevant site experience - those named in the application must have experience of the relevant site’s Pharmaceutical Quality System (PQS); it is not enough for them to be part of your future plan, they should have current experience for the relevant site, demonstrated through a copy of their CV.
- Unnecessary applications - QC laboratories. You do not always need to name contract laboratories; check the MHRA's guidance as submitting unnecessary applications wastes time and money.
- Unnecessary applications - Storage sites. Pure storage sites for stability samples, with no testing work, do not need to be named, although oversight of such storage by any MIA holder would be reviewed by the MHRA, it does not form part of the application process.
- Is the site really ready for inspection? All refurbishment works must be complete and processes and systems in place, which often is not the case. This means, according to the MHRA "most importantly of all", only when the site’s QP/QA team have performed a full scope self inspection as a ‘dry run’ and initiated an action plan to address any deficiencies.
Catherine Penny is a Senior Associate in the Dispute Resolution team and part of the Life Sciences Group.