With Determination No. 56 of July 17, 2025, AIFA has made available the operational instructions regarding the procedures for the granting of marketing authorization (MA) and the requirements to comply with Article 4 of Legislative Decree No. 10 of February 6, 2025, including for medicines subject to parallel importation and distribution. These instructions are included in Annex 1 and concern the obligation to place on the packaging of medicinal products a unique identifier (UI) encoded in a two-dimensional barcode (Data Matrix) and an anti-tampering device (ATD).

 According to Article 3 of the aforementioned decree, starting from February 9, 2025, all medicinal products referred to in Article 2, paragraph 1, letters a) and b) authorized for marketing in Italy must bear on their packaging a unique identifier (UI). The UI is a code generated for each individual package that enables full traceability of the medicine throughout the entire supply chain. Printed in Data Matrix format, the code includes at least the national product code, a serial number, the expiry date, and the batch number.

Additionally, all medicines marketed in Italy must carry an anti-tampering device (ATD) on their packaging. For human medicines subject to the UI requirements, the ATD must also include a security-featured label, in the form of value paper, which may also be implemented in a digital format, if provided for.

Human medicinal products not subject to the UI requirements must continue to bear the traditional pharmaceutical sticker ("bollino farmaceutico"), as set out in Article 5-bis of Legislative Decree No. 540 of December 30, 1992.

 The provisions of this determination take effect from the date of its publication on AIFA's official website, which occurred on July 17, 2025. However, the application of the new rules is framed within a two-year stabilization period, from February 9, 2025, to February 8, 2027. During this transitional phase, the UI and ATD may be replaced by the pharmaceutical sticker (bollino farmaceutico), including for batch release purposes, and the sticker may serve as an ATD for any human medicinal product.