Published in the Italian Official Gazette the Legislative Decree No. 10 (February 6th 2025), which aligns national regulations with the European FMD (Falsified Medicines Directive). Below is a summary of the main provisions:

1. 𝐁𝐚𝐭𝐜𝐡𝐞𝐬 𝐫𝐞𝐥𝐞𝐚𝐬𝐞𝐝 𝐮𝐧𝐭𝐢𝐥 𝐅𝐞𝐛𝐫𝐮𝐚𝐫𝐲 8𝐭𝐡 2025: all batches (A, including H, C, and SOP/OTC) released until February 8th 2025, may be marketed with the current self-adhesive label (Bollino) until expiration.
2. 𝐒𝐭𝐚𝐛𝐢𝐥𝐢𝐳𝐚𝐭𝐢𝐨𝐧 𝐩𝐞𝐫𝐢𝐨𝐝: from February 9th 2025 to February 8th 2027 Qualified Persons (QPs) may release, for all medicines intended for the Italian market both inside and outside the scope of the FMD (Falsified Medicines Directive):
   • 𝐁𝐚𝐭𝐜𝐡𝐞𝐬 𝐞𝐪𝐮𝐢𝐩𝐩𝐞𝐝 𝐨𝐧𝐥𝐲 𝐰𝐢𝐭𝐡 𝐭𝐡𝐞 𝐜𝐮𝐫𝐫𝐞𝐧𝐭 𝐁𝐨𝐥𝐥𝐢𝐧𝐨 𝐥𝐚𝐛𝐞𝐥 (𝐀, 𝐢𝐧𝐜𝐥𝐮𝐝𝐢𝐧𝐠 𝐇, 𝐂, 𝐚𝐧𝐝 𝐒𝐎𝐏/𝐎𝐓𝐂
   • 𝐁𝐚𝐭𝐜𝐡𝐞𝐬 𝐞𝐪𝐮𝐢𝐩𝐩𝐞𝐝 𝐰𝐢𝐭𝐡 𝐃𝐚𝐭𝐚𝐦𝐚𝐭𝐫𝐢𝐱 + 𝐚𝐧𝐭𝐢-𝐭𝐚𝐦𝐩𝐞𝐫𝐢𝐧𝐠 𝐝𝐞𝐯𝐢𝐜𝐞 (𝐀𝐓𝐃) + 𝐚 𝐬𝐞𝐜𝐮𝐫𝐢𝐭𝐲-𝐟𝐞𝐚𝐭𝐮𝐫𝐞𝐝 𝐬𝐮𝐩𝐩𝐨𝐫𝐭 (𝐜𝐚𝐫𝐭𝐚 𝐯𝐚𝐥𝐨𝐫𝐢) produced by the Istituto Poligrafico e Zecca dello Stato (A, including H, C). The characteristics of the Datamatrix and the security-featured support (carta valori) shall be defined by two separate Decrees issued by the Ministry of Health (Ministero della Salute).
3. 𝐒𝐎𝐏/𝐎𝐓𝐂: for SOP/OTC products, in addition to the pharmaceutical label which during this stabilization period may also serve as a tamper-evident measure, the EU regulation security feature may also be affixed (or continue to be used).
4. 𝐒𝐚𝐧𝐜𝐭𝐢𝐨𝐧𝐬: penalties for failure to affix and activate the Datamatrix, anti-tampering device (ATD) and security-featured support (carta valori) on batches marketed after February 9th 2025, will not be applicable until the end of the stabilization period (February 8th 2027).