The Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) has provided Marketing Authorization Holders (MAH) with the criteria used to assign different MA numbers during the initial marketing authorization process or when requesting new pack sizes in addition or in replacement of those already authorized. To facilitate future submissions, an explanatory table has been prepared that summarizes the most common cases.
This table includes information on:
- The different cases identified;
- When different MA numbers are assigned in the context of the procedure for the initial marketing authorization or variation application to add new pack sizes;
- When different MA numbers are assigned within the procedure for the variation application to replace packaging;
- Clarifications or particular cases to consider as exceptions.
Regulatory Pharma Net provides full regulatory assistance during the whole product lifecycle and is ready to support companies on all regulatory needs and to guide them through any new AIFA requirement/procedure.