In brief

On 23 December 2022, the Italian Medicines Agency (AIFA) published on its website an update concerning the procedures for submitting the Active Substance Master File (ASMF), which is the document that the manufacturer of the active ingredient is required to submit to AIFA for the active substances contained in the medicine for which a marketing authorization (MA) has been applied for.

Key takeaways

In particular, the AIFA has clarified that the applicant for a MA, in case it intends to use an ASMF documentation, or the applicant for a MA variation concerning the introduction or modification of an ASMF, is responsible for verifying that the manufacturer of the active ingredient has already filed with AIFA the ASMF and/or the documentation regarding its update. In this regard, the AIFA also stressed that the absence of the ASMF results in the invalidity of the application for the MA/variation.

The procedures for filing the ASMF are available on the AIFA’s website at this link.