Nog even over de SAG procedure:
A debriefing meeting with the company will occur after the end of the SAG meeting.
During the debriefing with companies, any
regulatory discussion on the subsequent steps in the procedure should not be carried out, but a
separate meeting can be arranged by the (Co)Rapporteurs and the EMA product team following the
The SAG Answers and Comments to the Committee(s) will contain answers to the List of Questions
for the SAG, and a justification for each answer.
The draft “SAG Answer and Comments to the Committee(s)” relating to specific product(s) will be
released to the concerned company.
The List of Questions for the SAG, and the SAG Answers and Comments to the Committee(s) shall
be reflected in the Committee(s) Assessment Reports, as appropriate, and thus appended to the
relevant Committees’ opinion, where applicable.