Variations to Marketing Authorizations in Europe

During the development of a medicinal product, a lot of information is collected/stored. This information along with the appropriate application type is submitted to the proper regulatory authorities. Throughout this long process, more and more info is collected and stored due to changes, such as a product’s name, composition, or treatment purpose. These changes are referred to as variations.

A variation in medicinal products encompasses: (1) any change affecting the terms of marketing authorization, or (2) a change in the information previously provided to the relevant authority for said medical product in the European Economic Area (EEA).

In this course, you will learn about the different categories and types of variation, including how to assign significance, approval requirements, and more.

This course will cover:

• Defining variations – This session identifies and characteriszs the different types of variation.
• Determining variation types – This session looks at the reasons for variations and describes how to identify the type of variation appropriate for each change required.
• General procedural aspects – This session describes the different routes to regulatory approval of variations, identifies which is appropriate for a given product, specifies the supporting documentation necessary, and describes the provisions for grouping multiple variations into a single submission and for work sharing of regulatory assessment among member states.
• Variations via the Centralized Procedure – This session describes the processes specific to the submission and processing of variations notifications and applications through the Centralized Procedure.
• Variations via the Mutual Recognition Procedure – This session describes the processes specific to the submission and processing of variations notifications and applications through the Mutual Recognition Procedure.