The EESC welcomes:
- the Commission proposal, which makes an important contribution to the further improvement of medicinal product safety and the transparency of the assessment processes.the principle that the marketing authorisation holder will not have to pay fees twice for the same pharmacovigilance activity. It calls on the Commission to ensure that, simultaneously with the introduction of the new fees, national fees charged for the same activity are abolished.
- the proposal that the EMA will levy an annual flat-rate fee from marketing authorisation holders for pharmacovigilance activities. The Committee suggests that the flat-rate fee be suspended pending availability of these services.
- the proposal that fees should be shared as fairly as possible between all market authorisation holders affected and suggests that the proposed approach involving "chargeable units" should be reconsidered.
Related EESC opinions:
- Opinion on Medicinal products for human and veterinary use (INT/475, CESE 1025/2009)
- Opinion on Information to the general public on medicinal products - Regulation (INT/601, CESE 468/2012)
- Opinions on pharmaceuticals