![]() Commission Regulation (EU) No 712/2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products.In such case, the MAH will be requested to revise and supplement its variation application so that the requirements for a type II variation application are met (see “How shall my type IB variations be handled (timetable)?”). Refer also to 'when will my variation application be considered a type-II variation or an extension application?' below.ĭuring validation of an 'unforeseen' variation, submitted by the MAH as a type IB variation, the Agency may consider that the proposed variation may have a significant impact on the quality, safety or efficacy of the medicinal product. 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. The Variations Regulation and the variations guideline set out a list of changes to be considered as type-II variations. ![]() Type-II variations: questions and answersĬommission 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.
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