From October 19th this year, Scientific Advice applications will need to go through the EMA Regulatory and Scientific Information Platform (IRIS). You will need to have an active EMA account, be registered in the EMA’s Organisation Management Service (OMS) and have the appropriate user access role to do this.
This is already the route for Orphan Designation applications and other regulatory activities that we handle.
Contact us at Agos Pharma for European and UK Regulatory support: www.agospharma.com and queries@agospharma.com
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