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).
By using two separate dates, a distinction can be made between:
- the date of the last revision: when the amendment is implemented by the marketing authorisation holder (MAH);
- the most recent approval date by the FAMHP: when a dossier or cluster of dossiers is administratively closed.
In practice
- the MAH enters the date of the last revision in accordance with the guidelines set out in the document’s summary table;
- in addition, the FAMHP includes ‘FAMHP approval date’ in the product information, making it clear which date was added and by which party.
In addition, the document has been aligned with the latest version of the European Variations Regulation, including the requirement for annual updates, and with other national agreements.
Additional information
Excerpt from the official page. The original is authoritative.