Today, the Commission proposes to update and simplify the legislation on fees charged by the European Medicines Agency (EMA). The main objective is to ensure that these fees reflect better the underlying costs of the work done and coordinated by EMA.
When companies make a request related to a marketing authorisation for a medicine, they have to pay a fee to EMA for the agency’s assessment. This fee also includes the remuneration paid by EMA to national authorities involved in the assessment. The Commission proposal revises the entire EMA fee structure to ensure that the fees reflect better the relevant costs. The proposal also includes a cost monitoring mechanism and more flexibility to adjust fees to significant changes in costs. The proposal takes into account the specificities of the veterinary pharmaceutical sector by offering targeted fee reductions to support the availability of veterinary medicinal products.
Stella Kyriakides, Commissioner in charge of Health and Food safety, said: “The European Medicines Agency is one of the key pillars of a stronger European Health Union. Today’s proposal will allow EMA to claim fees which better cover its important work, including the remuneration of national competent authorities for their scientific contributions. The proposal also makes future adjustments of the fee system easier, and more sustainable. I expect the European Parliament and the Council to firmly support that proposal”.