IMA always requests an Icelandic translation of the whole English product information as approved in the procedure. The marketing authorization is granted including the Icelandic translation of the whole English product information approved in the registration procedure. If the applicant wishes to carve out patented indications, he should apply for a national variation with the following grouping: C.I.6 Change(s) to therapeutic indication(s), Procedure type IB, Deletion of a therapeutic indication. It is the responsibility of the applicant to carve out all information in the product information (SmPC, Package leaflet and labelling) that relates to the patented indication. When the applicant wishes to add the carved-out indication(s) after patent expiry, he should do so with a national application with the following grouping: C.I.z, Change(s) to therapeutic indication(s), Procedure type IA, Addition of carved indications. Then it is only allowed to change back to the originally approved product information.
(13.4.2016)