In brief
On 30 May 2023, the Italian Medicines Agency (AIFA) announced that, starting from the Scientific Technical Committee (STC) meeting in June 2023, a new simplified procedure will apply to applications for new MAs under national, mutual recognition and decentralized procedures submitted under Article 10(1) (generic medicines) and Article 10(6) (hybrid medicines) of Legislative Decree No. 219/2006 in order to streamline the relevant registration process.
Key takeaways
In particular, said procedure applies to applications for new MAs of generic and hybrid medicines in cases where the packaging of the medicine to be authorized (i) is perfectly comparable to that authorized for the reference medicine; (ii) falls within the range of that authorized for the reference medicine (in terms of dosage units and under the same form/strength); or (iii) is outside the range of those authorized for the reference medicine (in terms of dosage units and under the same form/strength) but it is perfectly comparable to the packaging authorized for another generic of the same reference medicine.
Under the simplified procedure, applications for new MAs of generic or hybrid medicines will be reviewed without the need to obtain the opinion of the STC. The new procedure also provides that all medicines to be authorized whose reference medicine has packaging classified in Class A or H will be classified in Class Cnn.
Lastly, for Cnn classified medicines, the application for the pricing and reimbursement negotiation can be submitted to AIFA’s Health Technology Assessment Department following the publication in the Official Journal of the resolution granting the MA.
