Concerned Comments on Day 70 Preliminary Assessment Report to be sent at Day 100 at the latest 1. This document is sent by: CMS Contact point, project team leader (name) phone email Assessors, if applicable (name e-mail, phone) Date/Day of procedure 2. This document concerns: Procedure number Name of the medicinal product in the RMS Name of the active substance Applicant Deadline for comments 3. Comments, general 3.1 Assessment of the RMS We endorse the RMS assessment, but also have additional comments We do not fully endorse the RMS assessment, and have other comments 3.2 Conclusions on the product Our conclusion is that the product is: Approvable, provided that satisfactory responses are given to the list of questions and/or the SmPC/PL/labelling is changed according to the comments Non-approvable 3.3. List of Questions/Proposed conditions for marketing authorisation We have grounds of potential serious risks to public health on the following part of the assessment report not already raised by the RMS as major objections Quality Non-Clinical Clinical
Concerned Comments on Day 70 Preliminary Assessment Report to be sent at Day 100 at the latest 1. This document is sent by: CMS Contact point, project team leader (name) phone email Assessors, if applicable (name e-mail, phone) Date/Day of procedure 2. This document concerns: Procedure number Name of the medicinal product in the RMS Name of the active substance Applicant Deadline for comments 3. Comments, general 3.1 Assessment of the RMS We endorse the RMS assessment, but also have additional comments We do not fully endorse the RMS assessment, and have other comments 3.2 Conclusions on the product Our conclusion is that the product is: Approvable, provided that satisfactory responses are given to the list of questions and/or the SmPC/PL/labelling is changed according to the comments Non-approvable 3.3. List of Questions/Proposed conditions for marketing authorisation We have grounds of potential serious risks to public health on the following part of the assessment report not already raised by the RMS as major objections Quality Non-Clinical Clinical
CMDh_205_2005_Rev04_2017_03.docx