Variation of marketing authorisation
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.
Variation procedure flow chart
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.
National Scope Variations
Declaration on pack sizes
Notice to the MAH or person / company authorized for communication on behalf of MAH regarding declaration on pack sizes in MR or DC Type B.II.e.5 variations of medicinal products (Change in pack size of the finished product)
