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Homepage Pharmaceutical Industry Medicines Marketing authorisation of medicines Details of marketing authorisation Questions and Answers – marketing… Amendment to the registration decree (September 1… Will the new procedure of processing applications…

Will the new procedure of processing applications affecting product information make it necessary to submit an application for a variation to marketing authorisation in case of a change to SPC, PIL and/or labelling?

Yes, the obligation of marketing authorisation holders to submit the respective application for a variation to marketing authorisation in case of a change to SPC, PIL and/or labelling remains unchanged.