How is the EU helping SMEs develop medicines?
The European Union recognise the key part that micro, small and medium-sized enterprises (SMEs) play in innovation of new medicines and the benefit that these provide for patients. At the same time they acknowledge that SMEs do not have the same resources as larger companies. So in 2005 they introduced financial and administrative help for SMEs. So far, this has totalled many millions of Euros.
Discover if your company can benefit
To qualify for these benefits your company would have to meet certain criteria. These include having a headcount of less than 250, and either a turnover of less than €50 million or a balance sheet of less than €43 million. For legal reasons, to register as an SME the company would have to be established in the EU. If your company is an SME based outside the EU, you can access these benefits via our company, which has been registered as an SME with the EMEA, and is able to help your company and act on your behalf, wherever in the world you may be based. To find out whether your company can benefit contact us.
How much could your company save?
If your company qualifies as an SME you could benefit from 90% reductions in the fees for scientific advice and inspections. Also you would be entitled to a 100% waiver of fees for certain administrative services. Furthermore, fees for marketing authorisation applications (MAAs) and inspections may be deferred until after the marketing authorisation is granted.
Free translation
Translating product information into all the languages of the European Union can place a considerable burden on your company, particularly with multiple revisions that are often called for during the assessment of an MAA. These are both costly and a significant logistical challenge. The EMEA will arrange translations for these product information texts free of charge for registered SMEs.
To find out how we can help you access these benefits, please contact us.