Classification of changes
Classification of changes
What impact does a change have on quality, safety, and efficacy?
Variations are classified into three different categories. The higher the risk of impact on the quality, safety, and efficacy of a medicinal product, the higher the classification of the variation.
In addition to these three types of variation, there is also the extension of marketing authorisation. This category comprises major changes to a medicinal product. The Variation Regulation (Regulation 1234/2008/EC; to be read in conjunction with Regulation 2024/1701/EC) describes the four different types of variations. One of the tasks of the regulatory affairs department is to classify each variation. The correct classification of variations is a complex process.
In addition to these three types of variation, there is also the extension of marketing authorisation. This category comprises major changes to a medicinal product. The Variation Regulation (Regulation 1234/2008/EC; to be read in conjunction with Regulation 2024/1701/EC) describes the four different types of variations. One of the tasks of the regulatory affairs department is to classify each variation. The correct classification of variations is a complex process.
