In brief
On 5 January 2024, the Italian Medicines Agency (AIFA)’s Resolution No. DG/526/2023 providing the list of medicines that must not be withdrawn from distribution and sale within the national territory, which, therefore, can’t be exported, was published in the Official Gazette.
Key takeaways
The Determination was issued pursuant to Article 1, paragraph 1, letter s), of the Legislative Decree No. 219/2006 which entrusts the AIFA with the power to temporarily block the export of medicinal products in order to prevent or limit shortages or unavailability, even temporary, on the market or in the absence of valid therapeutic alternatives.
