In brief
On 31 January 2024, the Italian Medicines Agency (AIFA) published the Guidelines on applications for marketing authorizations submitted through the national procedure.
Key takeaways
The purpose of the Guidelines is to provide detailed information about (i) the correct submission of applications for marketing authorization and the relevant administrative and technical documentation, (ii) the steps and timeframes for the AIFA’s assessment of same applications, including any requests for clarifications and/or further documentation, and (iii) the publication of the results of the preliminary assessment, the procedures for issuing the final resolutions as well as for their notification and publication in the Official Gazette.
The procedural aspects of the Guidelines relating to the timing and means of communications apply to applications submitted as of 1 March 2024.
