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Advice to Manufacturers Series

Advice to Manufacturers Series


The Advice to manufacturers series of guidance documents provides advice on key policies and procedures, facilitating the application process. It aims to guide applicants as they compile applications and engage with PQT/VCP.

Communication and Submission of Applications

Dossier and Data Requirements

Generating Data to Support Quality Assessments

Generating Data to support Safety Assessments

Assessment Process

Development of Specifications