The Centralised Procedure (CP) is one of three routes available to applicants to gain multinational marketing authorisation within the European Economic Area (EEA) on the basis of a single application. In the CP, one successful application leads to a marketing authorisation being issued by the European Commission that applies throughout the EEA. The CP is mandatory for certain types of products.
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.
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.
Module overview - Provides an overview of the content of the module and outlines related Zenosis modules.
An introduction to the Centralised Procedure - This session provides background information. It specifies the types of product for which the CP is mandatory and those for which it is optional. It discusses the types of Marketing Authorisation Application, and characteristics of the application procedure.
The Centralised Procedure process - This session takes you through the entire process from pre-submission to what happens after an Opinion has been received.
Assessment - Multiple-choice mastery assessment.