Are you a small or medium-sized enterprise (SME) established in the European Union (EU)/ European Economic Area (EEA)? If so the European Medicines Agency (EMA) provides incentives and support for SMEs developing medicines for humans.

Criteria
The main criteria are:

  • Head count (fewer than 250 employees) and annual turnover (not more than €50 million) or annual balance-sheet total (not more than €43 million)
  • Ownership structure, including any partnership or linkage.

The detailed criteria is set out in Commission Recommendation 2003/361/EC 

Interesting fact: SMEs developed nearly 20% of all human medicines recommended for authorisation in 2020; half of these target a rare disease.

Support
The support includes financial advantages such as fee exemptions and reductions for pre- and post-authorisation regulatory procedures, including scientific advice, inspections and pharmacovigilance. For detailed information on financial guidance see: https://www.ema.europa.eu/en/human-regulatory/overview/support-smes/financial-advantages-sme-status

EMA’s SME office offers guidance through advising, directing and liaising SMEs with relevant scientific and regulatory contact points within EMA; this can be on regulations, administrative requirements procedures and clinical data publication. You can also receive translation assistance upon grant of an initial marketing authorisation.

Above is just some of the support available for more information take a look at: https://www.ema.europa.eu/en/human-regulatory/overview/support-smes

Interesting fact: Between 2016 and 2020 the success rate for SME marketing authorisation applications for human medicines more than doubled, reaching 89% in 2020

Applying for SME status
To apply for SME status, enterprises should complete the electronic declaration form, select the ‘submit by email’ button on the last page of the form, and send it to sme@ema.europa.eu

The applicant should also send:

  • a signed and scanned version of the declaration form in PDF format
  • the most recent annual accounts (audited, if possible) for the applicant enterprise and, if applicable, those of any partner or linked enterprises to support the figures provided
  • proof of establishment of the company in the European Union/European Economic Area (EU/EEA)
  • a chart of the ownership structure of the applicant, including where applicable its parent and any other partner or linked entities

Interesting fact: Between 2016 and 2020 more than 4 in 10 medicines selected for EMA’s PRIME: priority medicines scheme were from SMEs. 

Once registered SMEs are included in an online SME register. This register is a public source of information on EU and EEA-based SMEs involved in manufacturing, development or marketing of medicines for human or veterinary use.

Also look out for our blog on SME status in the UK.

If you would like to discuss how Fusion Pharma can support you with applying for SME status, please email us at hello@fusion-pharma-limited.com or phone us on  +44 (0) 203 1379 799.