SME Office Addressing the needs of small and medium-sized enterprises (SMEs) and promoting innovation

An agency of the European Union

With the aim of promoting innovation and development of new medicines by SMEs, the European Medicines Agency provides incentives for SMEs that are developing human or veterinary medicines1. The SME Office offers assistance to SMEs through dedicated personnel within the Agency. SME definition Commission Recommendation 2003/361/EC defines micro, small and medium-sized enterprises. To qualify for SME status, companies must meet the following criteria: • be established in the European Economic Area (EEA) • employ less than 250 employees and have an annual turnover of not more than €50 million or an annual balance-sheet total of not more than €43 million. Depending on the category of the enterprise, some or all of the headcount and financial data from other partner or linked enterprises may need to be counted when calculating whether the SME criteria are met. Further information on the definition of an SME is available in the ‘User guide to the SME definition’2. SME qualification process The form 'Declaration on the qualification of an enterprise as a micro, small or medium-sized enterprise (SME)3’, available from the Agency’s website, should be completed and submitted to the SME Office, together with the most recent annual accounts, information on ownership, and proof of establishment in the EEA. According to Commission Regulation (EC) No 2049/2005 See European Commission/Growth/Publications See SME Office area at www.ema.europa.eu

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The applicant will receive an EMA-SME number once the SME status has been assigned. To maintain its SME status, the company should submit a completed declaration annually, based on its latest approved accounts. SME support The incentives offered by the SME Regulation apply to the human and veterinary sectors, and include: Regulatory assistance SMEs can benefit from direct regulatory assistance including SME briefing meetings, which aim to facilitate the interaction with the Agency and provide guidance on the EU regulatory framework and the tools to support innovation. Scientific advice SMEs are encouraged to seek scientific advice from the Agency early in the development process. This helps the sponsor to ensure that the appropriate studies are performed and maximises the chances of a successful marketing authorisation. A substantial fee reduction for scientific advice is available to SMEs (see table). Other incentives include: • fee incentives (see table) • organisation of info days and training sessions for SMEs • regulatory updates via SME Newsletters and mailings targeted to SMEs • assistance with translations of the product information required for the granting of an EU marketing authorisation • inclusion in the public SME register • guidance on clinical data publication and provision of a free redaction tool license

Fee incentives Activity/application

Fee incentives 90% fee reduction for non-orphan products

Scientific advice

100% fee reduction for designated orphan products 100% fee reduction for products granted eligibility to the Priority Medicines (PRIME) scheme

Inspection (pre-authorisation)

90% fee reduction and deferral 100% fee reduction for designated orphan products Fee deferral

Application for marketing authorisation

Conditional fee exemption4 100% fee reduction for designated orphan products Fee exemption for micro-sized enterprises

Post-authorisation procedures, including pharmacovigilance activities

Scientific services

40% fee reduction for small or medium-sized enterprises 100% fee reduction for designated orphan products during the first year after marketing authorisation 90% fee reduction for non-orphan products 100% fee reduction for designated orphan products

Establishment of MRLs5

90% fee reduction

Administrative services6

100% fee reduction

Inspection (post-authorisation)

90% fee reduction

MedDRA licence7

100% fee reduction

Details on fees and fee reductions are available in the explanatory note on general fees payable to the European Medicines Agency8.

In the event of a negative outcome, where EMA scientific advice has been sought and followed Maximum Residue Limits Excluding parallel distribution 7 For micro- and small-sized enterprises only 8 See fees area at www.ema.europa.eu 4 5 6

Useful sources of information EMA user guide for SMEs3

For information on administrative and procedural aspects of the pharmaceutical legislation SME public register3

For information on SME companies registered with the Agency European Small Business Portal

For information on the whole spectrum of EU policies, legislation, programmes and initiatives relevant to Europe's SMEs: http://ec.europa.eu/small-business/index_en.htm

Research funding

For information on EU funding: Cordis http://cordis.europa.eu/

Horizon 2020 https://ec.europa.eu/programmes/horizon2020/

Further information European Medicines Agency SME Office

30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 8787 Fax +44 (0)20 3660 5555 E-mail [email protected] Website www.ema.europa.eu

© European Medicines Agency, 2017 Reproduction is authorised provided the source is acknowledged

SME Office - European Medicines Agency - Europa EU

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