SME Representation

Benefits to Small and Medium-Sized Enterprises (SMEs) in the EU

Policy in the European Union supports and promotes innovation and development of small and medium-sized enterprises (SMEs), by helping such enterprises to overcome the significant financial and administrative hurdles of getting a product to market. For medicinal products, the European Medicines Agency (EMEA) has a dedicated SME office and offers considerable incentives to qualified SMEs.

Are you an SME?
To qualify and access the benefits provided by EMEA, an enterprise must meet the following criteria:
1. Headcount of less than 250 employees
2. Turnover less than €50 million OR a balance sheet of less than €43 million
3. Establishment in the EU
Opportunities for non-EU SMEs
If your company fulfils criteria 1 and 2, but you are based outside the EU, you can still access these benefits through a consultancy that is based in the EU and is registered with EMEA as an SME. ERA Consulting is registered with EMEA as an SME; therefore, we are able to facilitate access to the following benefits:
- Regulatory, administrative and procedural assistance by EMEAÕs SME office (e.g. for filing a marketing authorisation application or variation)
- 90% fee reduction for scientific advice procedures, other services such as translations, and inspections, e.g. GMP
- Fee reduction for establishment of maximum residue limits for veterinary products
Other benefits for SMEs with an orphan medicinal product
In this case, the following potential benefits accrue:
- 100% fee reduction for pre-authorisation inspections
- 100% fee reduction for marketing authorisation applications and for fees in the first year after the granting of a marketing authorisation
- 100% fee reduction for protocol assistance

To learn whether ERA can help you to access these benefits, please contact us.