UK licensed medicinal products and the challenges of exporting – Many clients contact us for information and help on expanding the scope of their WDA license to include the export UK licensed medicinal products without necessarily understanding the challenges of exporting UK licensed medicinal products.
UK licensed medicines are often considered in some countries to be of a much higher quality than the medicines produced locally or nationally within that country, and can therefore be in high demand.
Whilst this can appear to be a lucrative business opportunity to exploit, the challenges of exporting UK licensed medicinal products can be significant.
Your Quality Management System will need to be expanded to include appropriate procedures for preparing your consignments for export, as well as carrying out a robust route risk assessment and transport validation. You will need to ensure you have robust customer qualification processes in place for the destination country and appropriate arrangements in place for the completion of the Single Administrative Document for the export of each product type, including assigning the correct Commodity Code. A Quality Agreement must also be in place with any contractors who will be performing customs clearance of your freight on your behalf.
All of the above, and more, must be in place before you submit the variation to the MHRA to add Export to the scope of your WDA(H) license.
However, even once these tasks have been achieved, the challenges of exporting UK licensed medicinal products continues with the List of medicines that cannot be exported from the UK or hoarded.
Anyone intending to operate an export based business model must first ensure that none of the products they intend to export are contained on this list (which is updated regularly). There is also an obligation placed on WDA holders to not act in a way that could compromise the supply of any product in the UK.
At PCL we work with a range of clients who export medicines and therefore have a wealth of experience to draw upon if you are considering expanding your business into this area. Please contact us to arrange a scoping call with one of our consultants.