In brief
With judgement No. 5212 of 9 July 2021, the Council of State confirmed the decision of the Italian Medicine Agency (AIFA) whereby the latter requested a pharmaceutical company to remove from the package leaflet of an over-the-counter medicine all references to the indication concerning spastic-painful symptoms of the genitourinary tract, considering the relevant data inadequate to support such an indication.
In depth
In emphasizing that efficacy and safety evidences relating to a medicinal product must be grounded on clinical studies based on a rigorous scientific methodology, conducted on an adequate number of patients, the Council of State considered that the data submitted by the pharmaceutical company in support of the above indication were entirely provisional and partial and, therefore, not comparable to those resulting from clinical studies carried out pursuant to a rigorous scientific methodology.
In this respect, the Council of State also highlighted that the effectiveness and safety of a medicinal product and the favorable risk-benefit ratio are essential requirements for its placing on the market and reiterated the importance of updated studies on the effectiveness of the medicinal product that take into account the scientific progress as a condition for maintaining the marketing authorization and protecting the human health.
