SME Status

The European Medicines Agency (EMA) provides various incentives and support mechanisms for Small and Medium-sized Enterprises (SMEs) involved in clinical development. These incentives aim to facilitate drug development and bring innovative treatments to the market more efficiently. Additionally, the EMA offers expedited development programs to speed up the availability of important new drugs.

FGK Representative Service GmbH can act as your “Regulatory Consultancy” and applicant for SME status applications according to the Commission Recommendation 2003/361/EC concerning definition of micro, small, medium-sized enterprises.

Once granted SME status, you can benefit from various EMA incentives, including:

• Reduced regulatory fees
• Fee deferrals
• Access to tailored scientific advice
• Regulatory and administrative support by SME office
• Assistance with orphan drug designation
• Support through the Innovation Task Force (ITF) and other EMA resources
• Participation in training and workshops organized by the EMA

A drug development company that is not located in the European Union (EU) can still apply for SME status and benefit from EMA incentives, provided it meets certain criteria:

To qualify for SME status, a company must meet the EU definition of an SME, which includes criteria related to staff headcount, turnover, and balance sheet total:

Micro-SME:

• Fewer than 10 employees.
• Annual turnover or balance sheet total of not more than €2 million.

Small-SME:

• Fewer than 50 employees.
• Annual turnover or balance sheet total of not more than €10 million.

Medium-SME:

• Fewer than 250 employees.
• Annual turnover not exceeding €50 million or a balance sheet total not exceeding €43 million.

FGK Representative Service can support the entire application process for non-EU companies seeking SME status:

1. Establish a Legal Entity in the EU: Non-EU companies must establish a legal entity in the EU. FGK RS will act as the applicant and representative for the purposes of interacting with the EMA.
2. Register with the EMA's SME Office: FGK RS will register your company with the EMA's SME Office. The registration involves submitting an application form along with supporting documents that demonstrate the company meets the SME criteria.
3. Required Documentation: FGK RS will support you in completion of the SME Declaration Form, which includes details about the company’s structure, financial status, and staff headcount.

Once validated, the EMA will issue a confirmation of SME status. This status must be renewed annually by submitting updated financial and staff information. The EU-based legal representative must remain compliant with EU regulations and act as the point of contact for all interactions with the EMA.

By choosing FGK RS as your legal representative, we will follow the above mentioned steps and you will easily maintain compliance with EMA requirements, to effectively leverage the incentives and support mechanisms offered by the EMA to facilitate drug development processes.

For more information, contact us at info@fgk-rs.com