Update of document on approval dates for variations, renewals and notifications for medicinal products for human use

The document concerning the approval date for variations, renewals and notifications has recently been updated. The changes include a clearer distinction between the revision date and the approval date in the product information for medicinal products for human use. Since 1 June 2026, the revision date and approval date are presented in a new format in the summary of product characteristics (SmPC) and in the patient information leaflet. This procedure applies to the administrative finalisation of a variation, notification or five-yearly renewal resulting in an amendment to the marketing authorisation (MA).