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SME Representation

Qdossier obtained the EMA SME (Micro, small and medium-sized enterprise) status, which means we are eligible to benefit from provisions for financial and administrative assistance for SMEs, as laid down in Regulation (EC) No 2049/2005.

What is SME status and what does it mean for our customers?

To promote innovation and development of new medicines, EMA supports micro-, small- and medium-sized enterprises (SMEs) by providing incentives during pre-marketing as well as post-authorization procedures. In order to obtain SME status, companies need to meet certain criteria, the details can be found here.

Benefits for SMEs

Following incentives are provided by EMA to companies with SME status:

  • Reduction in EMA fee for scientific advice, inspection procedures, pharmacovigilance, and administrative services. More information about fee incentives can be found here
  • Assistance from the SME office about regulations, administrative requirements, or procedures: by phone at +31(0)88 781 8787 or by email
  • Request briefing meetings to engage in early dialogue with a multidisciplinary EMA team, discuss a regulatory strategy for product development, and find out about available procedures, guidance, and incentives
  • Receive translation assistance for the product information into all official EU languages for initial marketing authorization
  • Receive guidance on clinical data publication
  • Participate in training events
  • Receive support with looking for academic partners in the paediatric-medicine field (European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA))

Good to know

  • Between 2016 and 2020, more than 4 out of 10 medicines selected for EMA’s PRIME: priority medicines scheme were from SMEs
  • SMEs developed nearly 20% of all human medicines recommended for authorization in 2020; half of these target a rare disease

Companies outside EEA, in particular, can take advantage of our SME status. For this purpose, Qdossier can act as the EU partner to enable your access to EMA SME incentives.

More information

Marloes van der Geer
+31 416 707 998

More information about
SME representation support?