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Information for marketing authorisation holder

Implementation of Variations to, Renewals and Transfers of Marketing Authorisations

With a view to frequent questions from marketing authorisation holders, SÚKL hereby provides more details on the implementation of variations to marketing authorisations, including the specifics of individual types of variations, as well as information regarding the implementation of marketing authorisation renewals and transfers. The information provided herein is applicable to medicinal products authorised via national procedures as well as MRP/DCP.  

 

Final Sale of Medicinal Products Following Approval of Variation to, Renewal and Transfer of Marketing Authorisation

With a view to frequent questions from marketing authorisation holders, SÚKL hereby provides more details on the final sale of medicinal products complying with the data and dossier valid prior to the implementation of a variation to marketing authorisation, prior to a marketing authorisation renewal or prior to the implementation of a marketing authorisation transfer. The information provided herein is applicable to medicinal products authorised via national procedures as well as MRP/DCP.    

 

Information about the change in approach to the validation of the type II variation

State Institute for Drug Control informs the MAHs about a change in the approach to the validation of Type II variations.