EMA/CHMP/CVMP: New Q&A document for the Use of CEPs

Recommendation

14-16 May 2024
Vienna, Austria

Analytical Instrument Qualification
Practical Approaches for USP General Chapter <1058> Compliance in the QC Laboratory

In the middle of February, the document "QWP Questions and Answers (Q&A): how to use a CEP in the context of a Marketing Authorization Application (MAA) or a Marketing Authorization Variation (MAV)" prepared by the EMA, the CHMP (Committee for Medicinal Products for Human Use) and the CVMP (Committee for Medicinal Products for Veterinary use) was published on the EMA website for the first time. The Q&As should be seen as an orientation for marketing authorization holders and applicants when submitting applications and variation notifications. They explain the use of CEPs in this regard. Excipients that are described by a CEP and are used as an API are also mentioned here.

The list of questions and answers consists of the following four chapters and their subchapters:

• 1. Introduction
• 2. Summary of MAH/Applicant responsibilities
• 3. Information to be included in the MA application/dossier
   - 3.1. Should a QP (qualified person) declaration be submitted when a CEP is used as the means of submission of data on the active substance in a MAA or MAV and which are the sites to be included in? (QP in Module 1/ VNees Part 1)
   - 3.2. What standard information should be submitted in CTD sections 3.2.S / 3.2.R or VNees Part 2C of the MA dossier? (Module 3, subsections of S)
   - 3.3. Specific situations
• 4. Changes to the CEP status
   - 4.1. What should be considered in case of CEP revisions?
        - 4.1.1. Is it possible to use active substance batches covered by a superseded CEP?
   - 4.2. What should be considered in case of CEP suspensions or withdrawals?

The complete "QWP Questions and Answers (Q&A): how to use a CEP in the context of a Marketing Authorisation Application (MAA) or a Marketing Authorisation Variation (MAV)" can be found on the EMA website.