18.12.2025
To the attention of marketing authorization holders
Regarding the date of revision of the text of Annex 1 – Leaflet and Annex 2 – Summary of Product Characteristics for type IA and IANI variations:
– in Annex 1 – Leaflet and Annex 2 – Summary of Product Characteristics, the NAMMDR shall mention the implementation date declared by the applicant in the eAF (electronic application form);
– with regard to Annex 3 – Labelling information, if the changes brought by type IA and IANI variations impact this Annex as well, the implementation may take place simultaneously with the implementation in the Leaflet and in the Summary of Product Characteristics, in other words on the date of implementation declared by the applicant in the eAF (electronic application form).