CRED 8 Presentations

01/07/2024

Exceptional circumstances (1)

• Legal basis: Art. 14 (8) of Reg. (EC) 276/2004 • Products for which applicant can’t provide comprehensive E & S data because: • Indications encountered so rarely that the applicant cannot reasonably be expected to provide comprehensive evidence, or • In the present state of scientific knowledge, comprehensive information cannot be provided, or • It would be contrary to generally accepted principles of medical ethics to collect such information

The Organisation for Professionals in Regulatory Affairs

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Exceptional circumstances (2)

• Requirement for the applicant to introduce specific procedures, in particular concerning the safety, notification to CAs of any incident relating to its use, and action to be taken – part of Risk Management Plan (RMP). • Inform EMA of intent to request MA under ECs at least 6m prior to submission • Rapporteur reviews appropriateness of request as part of assessment

The Organisation for Professionals in Regulatory Affairs

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