In brief
On 27 June 2023, the Italian Medicines Agency (AIFA) announced the release of new features for the e-Dossier Price and Reimbursement web portal (“Portal”). The Portal, available at the AIFA Services Portal, enables the preparation of dossiers in digital format to support reimbursement and price claims.
Key takeaways
Among the new features introduced is the extension of the Portal to the dossiers of the following simplified procedures: i) reimbursement of extensions of indications already reimbursed to the originator for equivalent medicines or biosimilars; ii) reimbursement of new packages due to changes in the primary packaging; and iii) new packages referring to changes (increases and reductions) in the number of dosage units or changes (increases and reductions) in the dosages of medicines with a different number of dosage units or dosages from the medicines.
