EMA advises companies to apply for or renew their SME status well in advance of a planned regulatory submission to EMA.
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To be eligible, companies, companies need to have a valid SME status that EMA assigned or must have submitted a renewal declaration to EMA before the expiry date of the SME status, at time of submission of an application or request.
For details about fee reductions and waivers, and the application of incentives, see the working arrangement and 'questions and answers' documents on Fees payable to the European Medicines Agency.
Companies can contact EMA's SME office for any question relating to the SME definition and the application of incentives before formally submitting an SME declaration in relation to fees.
Companies do not need to obtain confirmation of a fee incentive from EMA. Incentives will be applied once the SME office assigns the SME status. For more information, see Applying for SME status.
Fees will be subject to corrections if a company wrongly claims a fee incentive.
For detailed information on which fee incentives correspond to which procedure (EMA or centralised unless specified), see the table below.
In case of a merger or acquisition impacting the applicant’s SME status, or if a product is subject to out-licensing to a non-SME legal entity, SME incentives will cease to apply from the date on which the merger / acquisition or out-licensing took place.
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 SME user guide.
| 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marketing authorisation | Fee deferral until the outcome of marketing authorisation application (positive, negative or withdrawn application) for non-orphan products Conditional fee exemption, where EMA scientific advice is taken into account and a marketing authorisation application is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 |
Full details of fee determinations, exemptions and payment can be found at Fees payable to the European Medicines Agency.
Please note that SME status applications which are withdrawn by the applicant or closed by EMA may lead to corrected invoices being issued.
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).
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