In brief

With judgment No. 2434, published on 8 March 2023, the Council of State upheld the appeal against the AIFA’s decision ordering the withdrawal from the market of a homeopathic drug on the basis of a discrepancy between the drug identified in the MA renewal application and the one actually marketed.

Key takeaways

In the relevant proceeding the appellant claimed the unlawfulness of the AIFA’s decision based on the fact that the same Authority authorized, through the silence consent mechanism, the requested variations whose implementation was made conditional by the relevant marketing authorization holder upon the granting of the MA renewal.

In this regard, the court of first instance rejected the appeal filed by the appellant and endorsed the interpretation proposed by AIFA, pursuant to which the request for variations should fall within the scope of article 35, paragraph 1a, of Legislative Decree 219/2006, thus resulting in the impossibility of applying any condition.

Conversely, the Council of State found that the AIFA could have avoided the disputed discrepancy between the formal and substantive administrative status of the medicinal product from the outset by expressly rejecting the request for variations. Based on these considerations, the Council of State stated that it was unreasonable for the AIFA to question the validity of the silent consent formed several years ago to the prejudice of the appellant, which legitimately acted in line with the authorization, and, therefore, upheld the appeal.