CRED 8 Presentations

01/07/2024

 Considerations for SMEs

Reg. (EC) No 2049/2005

The Organisation for Professionals in Regulatory Affairs 59

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Assignment of SME status • Registration with EMA SME Office • For enterprises/applicants within EU/EEA • SME criteria defined in Recommendation 2003/361/EC:  Headcount <250 and annual turnover not more than € 50 mil or balance sheet not more than € 43 mil. • Partner enterprises and linked enterprises affect te calculation • Submit information to show compliance with criteria • Limited validity, renewable

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The Organisation for Professionals in Regulatory Affairs

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