SME registration support

Small and medium-sized enterprises (SMEs) play an important role in the European economy and are a major driver of innovation. As such, the EU supports SMEs through numerous programmes and incentives. In particular, the European Medicines Agency (EMA) offers SMEs that develop medicinal products, significant fee reductions and exemptions for its pre- and post-authorisation regulatory procedures such as scientific advice or marketing authorisation applications.

To qualify for these incentives, companies can apply to be registered as an SME by the EMA if they meet the SME criteria. Specifically, an SME must have fewer than 250 employees and either an annual turnover of less than 50 million Euro or an annual balance-sheet total of less than 43 million Euro. Additionally, the SME must be established in the European Economic Area (EEA).

When determining if the SME criteria are met, the company’s ownership structure is also considered. Here, a distinction is made based on the enterprise’s relationship with other companies. Generally, an autonomous enterprise is either entirely independent or has only a minority holding with other companies. If holdings are between 25% and 50% with other companies, this is considered a partner enterprise, while majority holdings are viewed as a linked enterprise.

Depending on these types of relationships with other enterprises, all or a proportion of linked and partner enterprises’ data may need  to be included in the calculation when determining if the SME thresholds are met.

In order to apply for an SME status and register a company as an SME with the EMA, a declaration form has to be completed and submitted, along with the relevant supporting documentation. Upon successful review, the company receives a notification and SME number from the EMA and will be included in a public SME register. The SME status will expire two years after the date of the accounts on which the declaration was based and can be renewed by submitting a renewal declaration form.
In certain cases, the SME incentives offered by the EMA may also be granted to companies outside the EEA through an EU/EEA-established regulatory consultancy. EUDRAC has an SME status itself and can assist those non EEA-companies that meet the requirements to obtain SME status for the EU.