Question to the Department of Health and Social Care:

To ask Her Majesty's Government whether they intend to hold discussions with the UK Medicines Verification Organisation on the need to benchmark the (1) set up, and (2) annual operational, fees paid by companies who are Marketing Authorisation Holders with National Medicines Verification Organisations in other comparable European countries such as France and Germany.

SecurMed, the United Kingdom’s National Medicines Verification Organisation, is responsible for the fee model and level of fees. In their supervisory capacity, the Department and the Medicines and Healthcare products Regulatory Agency have been involved in discussions with SecurMed to challenge and seek to influence the pricing model to ensure that the UK’s fee structure is fair and proportionate.

The European Commission has confirmed that the fee model being used by SecurMed is in line with the majority of other National Medicines Verification Organisations across the European Union.

However, in light of feedback on the potential impact of the proposed level of fees for smaller companies, SecurMed has announced an annual fee waiver scheme for the Marketing Authorisation Holders (MAH) Set up Fee and Annual MAH Operational Fee applicable to those MAH or Parallel Distributor legal entities who can demonstrate that they are a micro MAH in the relevant year.

There continues to be on-going efforts at a national and European level to ensure that fee models take into account the specific situation of small companies.