H-1051 Budapest, Zrínyi u. 3.

Tel.: (1) 8869-300, E-mail: ogyei@ogyei.gov.hu

Mail: 1372 P.O. Box: 450.

MAGYAR

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.

Notice to applicants - type IA & IB variations

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)

Information concerning the implementation date of variations

Last updated: 2008.08.19 10:59