CRED 8 Presentations

08/07/2024

MRP/DCP - Practical Tips Response strategy and clock-stop List of questions/issues from RMS/CMS ● Potential serious risks to public health (2006/C 133/05)

– Preclude for recommendation for marketing authorisation if non-resolved – Scientifically justified and not based on pure national requirements ● Point for clarifications ● Across Quality, Nonclinical, Clinical, PhV/Risk Management System, Overall risk-benefit, Product Information

MRP ● Very short timelines/No clock-stop ● Use of risk register to proactively anticipate concerns

DCP and Clock-stop ● Final response document to the within a period of 3 months, which can be extended by a further 3 months. ● Draft responses to the RMS and agrees the date with the RMS for submission of the final response – Adequacy of response strategy

● Consider a teleconference with your RMS, if possible – Highlight conflicting questions across member states – Clarify questions and discuss next steps

The Organisation for Professionals in Regulatory Affairs The Organisationfor Professionals in Regulatory Affairs

39

RMS/CMS comments

Potential Serious Risk to Public Health (PSRPH)

● Commission Guideline (2006/C 133/05) on the definition of a potential serious risk to public health (PSRPH) A ‘potential serious risk to public health’ is defined as a situation where there is a significant probability that a serious hazard resulting from a human medicinal product in the context of its proposed use will affect public health ● PSRPH can be defined in the area of Efficacy, Safety, Quality, Overall benefit-risk and Product information.

● Annex to guidelines lists examples of issues which normally would not be considered as grounds for a PSRPH

The Organisation for Professionals in Regulatory Affairs The Organisationfor Professionals in Regulatory Affairs

40