In the event of a change to one or more documents in the dossier of the medicinal product, the Marketing Authorization Holder must submit an application for a variation (together with the relevant supporting documentation) to the Medicines Council, in accordance with Commission Regulation (EC) No 1234/2008. The application must be submitted in a form determined by the Medicines Council and must be accompanied by the specified fees.
The application is assessed and then the Medicines Council, if it deems it necessary to modify the marketing authorization, proceeds to amend it.