Variation of a marketing authorisation means that there has been a modification which is being applied for concerning the documentation valid for the medicinal product.
Type IA and Type IB „minor” variations: listed in the Annex I. of decree 1084/2003/EC, and are suitable with the conditions defined there.
Type II „major” variation: the variation cannot be defined as a „minor” modification according to the Annex I. of decree 1084/2003/EC or as an extension of the marketing authorisation.
