To the attention of holders of MA’s: new definition for the approval date mentioned in SmPC and PIL.

When the administratively closing of a variation or renewal leads to an update of the marketing authorization (MA), a new methodology to determine the approval date mentioned in the summary of product characteristics (SmPC) and patient leaflet (PIL) will be used from 15/6/15.

Starting from 15/6/15, when the famhp is closing administratively a variation and as result of this closing you receive an update of MA, the following approach will be used to determine the approval date mentioned in SmPC and PIL: the approval date mentioned in the SmPC and leaflet is the date of the scientific approval. This is also the date that will be mentioned in the variation table. This allows the firm to use the correct date when implementing the change before the dossier is administratively closed by the Agency.

The same approach will be used for determine the approval date in the SmPC and leaflet when closing a renewal. Although a renewal can only be implemented when receiving the updated MA, the same approach is used to harmonize the way of working and by doing so to avoid mistakes.

When the update of the MA is a result of the closing of a cluster of dossiers, the date that will be mentioned in the SmPc and leaflet will be the most recent approval date.

The table in the document “new definition of the approval date in SmPC and PIL” gives an overview on how the famph will determine the approval date until 15/6 and staring form 15/6/15.

Last updated on
12/02/2016