In brief

With decision No. 7759 published on 8 May 2023, the Administrative Court of the Lazio Region ruled on the determination whereby the Italian Medicine Agency (AIFA) rejected the request for an exemption from the withdrawal of a marketing authorization (MA) filed by the relevant holder due to the discontinuation of the supply of the active ingredient by its manufacturer.

Key takeaways 

The marketing authorization holder’s request was grounded on the provisions of the Guidelines on the “Sunset Clause” adopted by the AIFA on 3 March 2015, which allow the exemption from the withdrawal of the MA when, on the date of the request, there is an ongoing procedure related to the MA concerning changes necessary for the manufacturing of the medicine, including the replacement of the manufacturer or supplier of the active ingredient.

The AIFA instead refused to grant the exemption on the grounds that, on the date of the request for exemption, there was no record of any variation procedure relating to the replacement of the manufacturer of the active ingredient and that the information provided by the marketing authorization holder in the same request was to be considered a mere declaration of intent regarding the research for a new manufacturer. In this regard, the Administrative Court upheld the appeal considering that the AIFA did not conduct an adequate investigation of the request aimed at verifying the seriousness and feasibility of the research process declared by the applicant and that it only carried out a formal assessment of the invoked exemption criteria in violation of the principle of fair cooperation.