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[insert only for CHMP/CAT adopted doc & add EMA header and footer]Amsterdam, insert full date insert Doc.Ref.: Committee for Medicinal Products for Human Use (CHMP) Committee for Advanced Therapies
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How to fill out chmp-rapporteurs-assessment-report-template-similarity-rev

01
Download the CHMP rapporteurs assessment report template for similarity revision.
02
Fill out the sections of the template as per the instructions provided.
03
Provide detailed information and analysis for each section, including data on the similarity comparison.

Who needs chmp-rapporteurs-assessment-report-template-similarity-rev?

01
Regulatory authorities responsible for reviewing applications for marketing authorization of generic medicinal products may need the CHMP rapporteurs assessment report template for similarity revision.

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It is a template for assessing the similarity of reports submitted to the CHMP rapporteurs.
All applicants submitting reports to the CHMP rapporteurs are required to file this template.
The template should be filled out according to the guidelines provided by the CHMP rapporteurs.
The purpose is to assess the similarity of reports submitted to the CHMP rapporteurs for consistency and accuracy.
The template requires specific details about the content of the reports and any discrepancies found.
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