8. Post-Approval

These major variations are defined as variations which are not an extension and which may have a significant impact on the quality, safety or efficacy of a medicine.

A Guideline clarifies the conditions which must be met.

The Variations Regulation and the Variations Guidelines set out a list of changes to be considered as Type II variations. In addition, any other change which may have a significant impact on the quality, safety or efficacy of the medicinal product must be submitted as a Type II variation.

Type II variations need to be approved before they can be implemented.

Type II variations can only be implemented once the MAH has been informed of the favourable outcome by the authority.