On 11 September 2026, the Decree approving the National Guidelines on the provision of personalised access to medicines through public and private pharmacies open to the public was signed by Undersecretary of State for Health Marcello Gemmato.
The service is defined as an assistance-related activity, carried out by the pharmacist under their own responsibility, aimed at supporting the correct use of medicines and patients’ adherence to treatment.
At the patient’s request and in accordance with the individual therapeutic regimen, the service involves the preparation of personalised dosage packages by removing medicines from their original packaging and subsequently repackaging them. The service may only be provided by the pharmacy responsible for the patient, using medicines dispensed by that same pharmacy.
Specific conditions must be met in order to activate the service, including a request from the patient or an authorised person, the availability of the therapeutic regimen and the required documentation, appropriate organisational requirements and operating procedures, as well as the pharmacist’s positive assessment of the feasibility and safety of the preparation. This assessment must be formally documented in the Preparation and Traceability Record.
The service applies to solid oral dosage forms. Where the medicinal product cannot be kept in its primary packaging, physically unstable solid dosage forms and antineoplastic medicines are excluded.
The service may also be provided for narcotic and psychotropic medicines belonging to Sections B and C of the Table of Medicinal Products under Presidential Decree No. 309/1990, which are subject to entry/exit register requirements, as well as those belonging to Sections D and E. Section A medicines are excluded.
All obligations established by current legislation remain fully applicable, including those concerning record-keeping, custody, storage and traceability, with no exceptions.
Personalised packaging must be identified and labelled with all information necessary to ensure proper management and traceability, including patient identification, a unique packaging identification number, preparation date, name, strength and batch number of each medicinal product contained, directions for use, duration of treatment, storage conditions and expiry/use-by date.
The service must be carried out within the pharmacy, in accordance with the Good Preparation Practices (GPP) set out in the current edition of the Italian Pharmacopoeia, either in the laboratory or in a suitable room equipped to carry out preparation, packaging, labelling and quality-control operations.
Pharmacies intending to activate the service must notify the competent local authority of its commencement.
As highlighted by Hon. Marcello Gemmato, the Guidelines aim to strengthen collaboration between physicians and pharmacists, including through systematic verification of treatment adherence and the appropriateness and correctness of prescriptions.
The objective is to ensure consistent implementation of the service nationwide, reducing inequalities in access while strengthening territorial healthcare and the role of community pharmacies and pharmacy-based healthcare services.
The Decree will enter into force on the day following its publication in the Official Journal of the Italian Republic.
