Question to the Department of Health and Social Care:

To ask Her Majesty's Government whether they have carried out an impact assessment on the effect of SecurMed’s fee structure on small and medium-sized enterprises; and if so, whether they will place a copy of that assessment in the Library of the House.

The Department and the Medicines and Healthcare products Regulatory Agency have not carried out an impact assessment on the effect of SecurMed’s fee structure on small and medium-sized enterprises. In a supervisory capacity, our aim is to ensure that SecurMed is complying with the regulation in a fair and proportionate way. In considering SecurMed’s fee structure we took account of:

- the European Medicines Verification Organisation’s blue print (resulting from their assessment of different cost-allocation models);

- aligning the United Kingdom’s approach with other European Union National Medicines Verification Organisations; and

- seeking to ensure that the fee model is fit for purpose for the UK.