The Legislative Decree No. 274/2007 amending legislative decree 219/2006 (the “Decree”) introduces, inter alia, new rules on the advertisement of OTC medicinal products and medical information activities addressed to health care professionals operating in non-public structures.
In particular, Article 21 of the Decree, amending Article 118 of Legislative Decree No. 219/2006 (the so-called, Italian Medicines Code, the “Code”) introduces the possibility for OTC medicinal products to be advertised before the general public in cases where a specific authorisation from the Ministry of Health has not been obtained.
In particular, new Article 118 introduces the possibility for OTC medicinal products to be freely advertised in conjunction with pictures or graphic representations of the outer or inner packaging (i) in daily newspapers or periodic magazines where such advertising entirely reproduces the package leaflet information; and (ii) with price labels and labels referring to discount prices applied by dealers.
In addition to the above, Article 23 of the Decree, amending Article 123 of the Code, provides that “information material intended for scientific or work purposes and not strictly related to the medicinal product” can be freely distributed to healthcare professionals also operating in non-public structures, provided that requirements of Ministry of Health Decree dated 14 April 2008 are met. In particular, the latter Decree, which includes a list of possible promotional materials that can be freely distributed by companies to healthcare professionals operating also in non-public structures, indicates AIFA as the competent authority responsible for deciding on whether these materials comply with the requirements imposed by the legislation.