Financial advantages of SME status
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).
EMA advises companies to apply for or renew their SME status well in advance of a planned regulatory submission to EMA.
More information:
To be eligible, companies need to have a valid SME status assigned by EMA.
Companies do not need to obtain confirmation of a fee incentive from EMA. Conditional fee exemptions, where applicable, should be requested at the time of dossier outcome (see below).
| Procedure | Fee incentives |
|---|---|
| 90% fee reduction for non-orphan products |
| 100% fee reduction for designated orphan products | |
| 100% fee reduction for products granted eligibility to PRIME | |
| 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| Fee deferral until the outcome of marketing authorisation application (positive, negative or withdrawn application) |
| Conditional fee exemption, where EMA scientific advice is followed and a marketing authorisation application is not successful | |
| 100% fee reduction for designated orphan products | |
Post-authorisation procedures (e.g. variations, extensions)
| Fee exemption 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) | |
Scientific services (e.g. certification, Article 58 procedures and consultation on medical devices)
| 90% fee reduction for non-orphan products |
| 100% fee reduction for designated orphan products | |
| Establishment of maximum residue limits | 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 |
| Pharmacovigilance (see below for more details) | Fee exemption for micro-sized enterprises |
| 40% fee reduction for small or medium-sized enterprises |
Full details of fee determinations, exemptions and payment can be found at Fees payable to the European Medicines Agency. EMA strongly advises companies to contact the SME office to discuss access to incentives following a merger and acquisition or product out licensing. For more information, see sections 2.4.1 and 2.5.3 of the guidance in the SME user guide.
To be eligible for fee incentives relating to pharmacovigilance activities, applicants need to have a valid SME status assigned by EMA, or must have submitted an SME declaration or renewal to the Agency.
Pharmacovigilance fees will be subject to corrections where a company wrongly claims a fee incentive for pharmacovigilance activities.
Companies are therefore advised to contact the SME office for any question relating to the SME definition prior to formally submitting an SME declaration in relation to pharmacovigilance fees.
For full details on fee determination, payment and fee exemptions and reductions for pharmacovigilance fees:
For details about fee waivers applicable to MedDRA subscriptions for micro and small-sized enterprises:
EMA provides free-of-charge translation assistance of product information in all EU languages for initial EU marketing authorisations (this excludes Icelandic and Norwegian).
For more information:
