CRED ERP 25

01/07/2025

SNSA how does it look like (final report)

The Organisation for Professionals in Regulatory Affairs

11

National Scientific Advice MEB (1/5)

No scientific advice possibleduring an ongoing procedure!!

The MEB has 4 types of scientific advice

1. Simple advice : regulatory advice, advice relating to the

pharmaceutical or pre-clinical aspects of the medicinal product, or follow-up advice (general written advice only within 7 weeks after receipt full documentation)

2. Partially multi-disciplinary scientific advice: purely clinical advice regarding the efficacy and safety of a medical product, whether or not in combination with pharmaceutical or pre-clinical, or a combination of pharmaceutical and pre-clinical advice

The Organisation for Professionals in Regulatory Affairs

12