Italian pharmaceutical regulatory updates

The Italian Ministry of Health and the Italian Medicines Agency (AIFA) have issued new regulatory guidelines and updates concerning medication management and documentation.

In mid-October 2026, the Ministry of Health established national guidelines for ‘deblistering’, a service where pharmacists repackage oral solid medications into customized doses to improve therapeutic adherence for chronic patients. The decree defines this as a professional healthcare activity rather than a manufacturing process, requiring a direct relationship between the pharmacist, physician, and patient. The service excludes physically unstable solid forms and antineoplastic drugs.

Following this, updates were published in the Official Gazette regarding package inserts for several specific medications, including Eltrombopag, Ramipril, and Citalopram. Pharmacists are mandated to provide these updated leaflets to patients, though regulations allow for the use of existing stock under certain disposal conditions.