Template 6 peer review template - European Medicines Agency
Committee for Advanced Therapies (CAT)
Peer review of the certification procedure by
|Invented name of the medicinal product: | |
|INN (or common name) of the active substance(s): | |
|Applicant: | |
|Indication(s) | |
|Pharmaco-therapeutic group | |
|(ATC Code): | |
|Pharmaceutical form(s) and strength(s): | |
|CAT Lead Coordinator’s contact person: | |
| | |
|CAT Peer reviewer’s contact person[1]*: | |
| | |
|EMEA Coordinator: | |
|Names of the CAT Lead Coordinator’s assessors: | |
|(Internal and external) | |
1. Comments
The(se) comment(s) concern(s) the following parts of the Assessment Report:
Quality
Non-Clinical
Draft RSI
1.1 Quality Aspects
1.2
2. Comments on the Conclusions and Request for Supplementary Information (RSI)
2.1 On the Conclusions
Yes No
|I concur with the Coordinator’s Conclusions | | |
I have some Specific Comments on the Conclusions (please elaborate):
2.2. Request for Supplementary Information (RSI)
2.2.1. Quality Aspects
2.2.2.
-----------------------
[1] Please list all the peer reviewers
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