In order to harmonise the Italian marketing authorisation (AIC) numbers of medicinal products authorised through the centralised, mutual recognition procedure and decentralised procedure and national procedures, while maintaining the existing coding structure, the suffix “/E”, which is currently appended after the 9 digits identifying the medicinal product pack, is no longer considered necessary and is therefore being removed.

The aforementioned suffix is not referred to in the Italian Ministry of Health Decree of 6 March 2025 entitled “Specifiche tecniche dell'identificativo univoco «Data Matrix» dei medicinali ad uso umano”, where the AIC number is specified.

Therefore, as from the date of publication of this notice on the AIFA website, the suffix “/E” will no longer form part of the AIC number of medicinal products authorised through the centralised procedure and, consequently, will no longer appear on the pharmaceutical sticker (bollino ottico), in the Blue Box, or in administrative acts issued by AIFA.

To allow for the necessary implementation of manufacturing processes, IT systems and packaging materials, the use of existing artworks and pharmaceutical stickers bearing the suffix “/E” is permitted until 9 February 2027, as well as the supply disposal of batches already produced/packaged or released by that date till the shelf-life date indicated on the outer/immediate label.

Specific cases may be submitted to AIFA for evaluation.

As from 10 February 2027, the suffix “/E” must no longer appear on any identifying element of the medicinal product, including the pharmaceutical sticker and the Blue Box.
AIFA authorisation acts already adopted and transmitted for publication in the Italian Official Gazette (Gazzetta Ufficiale della Repubblica Italiana) by the date of publication of this notice may continue to display the suffix “/E” in the AIC number, without the need for amendment or correction.

This notice cancels and replaces the notice published on 15 June 2026.