14-16 May 2024
Vienna, Austria
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:
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.