The European Medicines Agency (EMA) offers full or partial fee exemptions for its pre- and post-authorisation regulatory procedures for micro, small and medium-sized enterprises (SMEs) who want to develop and market medicines in the European Union (EU) and the European Economic Area (EEA).
| Procedure | Fee incentives |
|---|---|
| Scientific advice | 90% fee reduction for non-orphan products
100% fee reduction for designated orphan products 90% fee reduction for veterinary medicinal products |
| Inspection (pre-authorisation) | 90% fee reduction and deferral
100% fee reduction for designated orphan products |
| Application for marketing authorisation | Fee deferral until the outcome of marketing authorisation application (positive, negative or withdrawn application) for non-orphan products
Conditional fee exemption, where EMA scientific advice is taken into account and a marketing authorisation application is not successful (negative opinion, withdrawal); requested at the time of dossier outcome 100% fee reduction for designated orphan products |
| Post-authorisation procedures (e.g. variations, extensions) | 100% fee reduction for micro-sized enterprises
40% fee reduction for small or medium-sized enterprises 100% fee reduction for designated orphan products during the first year after marketing authorisation (reverting to fee incentives according to size thereafter) |
| Pharmacovigilance (centrally and nationally authorised products) | 100% fee reduction for micro-sized enterprises
40% fee reduction for small or medium-sized enterprises |
| Establishment of maximum residue limits for a veterinary medicinal product | 90% fee reduction |
| Extension or modification of maximum residue limit for a veterinary medicinal product | 90% fee reduction |
| Administrative services (excluding parallel distribution) | 100% fee reduction |
| Inspection (post-authorisation) | 90% fee reduction
100% fee reduction for designated orphan products |
Contact admin@pharma-design.co.uk to have assistance with SME status applications at EMA.