CRED 8 Presentations

01/07/2024

Example

• Company requests a scientific advice with regard to a future MAA for a medicinal products containing an active substance that has not yet been authorisedbefore in NL; • During meeting it is concluded that underlying documentation for the proposed legal base (WEU) might not be adequate/sufficient for the assessment of the benefit/risk balance; • Instead of requesting a follow-up advice the company submits the MAA under legal base 8(3); • Major concerns with regard to quality and completeness of the submitted documentation;  Interaction and dialogue are important: if advice is not clear than request clarification and/or follow-up advice

The Organisation for Professionals in Regulatory Affairs

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Take-home messages

 Scientific advice to be asked before dossier is finalised/study performed  Be aware: if you request scientific advice, adherence is recommended/ deviationis difficult;  Make sure that all participants speak and understand English (or Dutch in case of meeting at MEB with only Dutch people)  Pre-submissionmeeting usefulin case unexperienced company/first DCP e.g to discuss steps of procedure/possible strategy  See also later in this presentation (talking to regulators)

The Organisation for Professionals in Regulatory Affairs

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