SCCS – Opinions

Déc, 2022

Preliminary Opinions open for comments

The preliminary Opinions in this section have been developed by the SCCS on the basis of specific sets of data (dossiers) submitted by specific Applicants (e.g. Industry, Member State authorities, etc.) in order to satisfy specific regulatory requirements.

These preliminary Opinions have been recently approved and are now open for clarification/comment for a minimum period of 4 weeks (if possible, for a period of eight weeks). The exact timeline is given for each Opinion.

This publication intends to enable Applicants, but also other interested parties, to provide clarification/comment, if any, about the evaluation, interpretation, and incorporation of the submitted set of data in the SCCS preliminary Opinion.

Please note that this is NOT a public consultation process whereby new evidence or comments on the scientific basis of the preliminary Opinion are submitted for consideration in order to finalise the Opinion, nor is it an opportunity for the Applicant concerned to submit a totally new set of data that would lead to a new submission and mandate.

Clarifications/comments should preferably be numbered, clearly referring to specific sections of the Preliminary Opinion (to be indicated) and sent to the following mailbox only: