This module describes the various players in the procedure, the sequence and duration of the stages involved, and the requirements on content, format and timing of submissions.
Who will benefit from this module?
This module is primarily aimed at regulatory affairs professionals dealing with marketing authorisation applications and related submissions for regulatory approval in Europe. More generally, it will also be of interest to all those involved in the development and registration of medicinal products.
- Provide an overview of the CP process.
- Identify which products may/must use the CP.
- For products for which the CP is optional, outline the advantages and disadvantages of the CP compared with other routes to marketing authorisation.
- Describe requirements on content, format and timing of submissions.
- Specify the sequence and duration of the stages of the CP and the responsibilities of the participants.
- Describe the role of the European Medicines Agency and its relevant competent committee.
- Outline fast-track provisions.
- Describe the appeals procedure.
CPD Points: 1.5
Assessment: Multiple-choice mastery assessment
The Centralised Procedure process - This session takes you through the entire process from pre-submission to what happens after an Opinion has been received.