Commission Regulation (EC) No 1234/2008 (the Variations Regulation) defines a major variation of type II as a variation that is not an extension of the marketing authorisation (line extension) and that may have a significant impact on the quality, safety or efficacy of a medicinal product.
The Variations Regulation and the variations guideline set out a list of changes to be considered as type-II variations. In addition, any other change that may have a significant impact on the quality, safety or efficacy of the medicinal product must be submitted as a type-II variation.
Commission Regulation (EC) No 1234/2008 (the Variations Regulation) defines a major variation of type II as a variation that is not an extension of the marketing authorisation (line extension) and that may have a significant impact on the quality, safety or efficacy of a medicinal product.
The Variations Regulation and the variations guideline set out a list of changes to be considered as type-II variations. In addition, any other change that may have a significant impact on the quality, safety or efficacy of the medicinal product must be submitted as a type-II variation.
