Italy

Italian Medicines Agency warns MA holders of products imminently subject to ‘sunset clause’

Marco de Morpurgo

Last Friday, the Italian Medicines Agency (AIFA) published a warning to marketing authorisation (MA) holders concerning the imminent invalidity of certain MAs in application of the ‘sunset clause’ (Warning). Article 38 of the Italian Medicines Code, implementing Article 24 of the EU Medicines Directive in Italy, provides that an MA ceases to be valid if Read More

Excessive pricing of medicines and antitrust: not a great week for Aspen

Emilio De Giorgi

This week Aspen received two pieces of bad news. On 13 June, the South African Competition Commission (SACC) announced the opening of an investigation against Aspen for its suspected excessive prices in the provision of certain cancer medicinal products (Leukeran, Alkeran and Myleran). The following day, the Italian administrative court of Lazio rejected the appeal Read More

Advertising to the public of all non-prescription medicines (not just OTCs) now permitted in Italy

Roberta Errico

The Italian Council of State (Italy’s highest administrative court) has recently clarified the scope of permitted advertisement to the public of medicinal products in Italy: by its decision No. 2217 of 12 May 2017, it confirmed the admissibility of the promotion to the public of all non-prescription medicines (NPMs, also known with the acronym “SOP” Read More

Italian IAP finds that claims on medical devices are unlikely to be misleading if pre-approved based on scientific evidence

Carmen Castellano

The Italian self-regulatory advertising body (Istituto di Autodisciplina Pubblicitaria – IAP) recently held that promotional claims made in relation to CE-marked medical devices are unlikely to be misleading if those have been pre-approved by the Ministry of Health on the basis of scientific evidence pursuant to the rules pertaining to the promotion of medical devices. Read More

Italian Medicines Regulator and Competition Authority enter into collaboration agreement

Marco de Morpurgo

On 19 January 2017, the Italian Medicines Agency (AIFA) and the Italian Competition Authority (AGCM) signed a memorandum of understanding aiming at increasing cooperation and coordination of their respective enforcement functions including by means of information exchanges. The four-page document establishes a framework and sets forth specific means for enhanced cooperation between the two authorities, Read More