With reference to communication dated 20 September 2019, a change is made to the provisions on the types of variations to be submitted in order to delete and subsequently insert patented therapeutic indications.

Given that the updating of the product information (PI) of generic medicinal products for the purposes of deleting or inserting therapeutic indications due to the patent protection of the reference medicinal product should be managed at national level, including for mutual recognition products, as set out in CMDh document, please be informed that the Post Authorization Procedures Office will accept the submission of the following variations on a national basis:

• a type IA(in) C.I.z variation for the deletion of patented information from the PI of already authorised generic medicinal products, limited to the information contained in sections 4.1, 4.2 and 5.1 of the Summary of Product Characteristics (SmPC) and the corresponding sections of the Package Leaflet (PL)
• a type IA(in) C.I.z variation for the subsequent insertion of information no longer under patent for generic medicinal products, limited to the information contained in sections 4.1, 4.2 and 5.1 of the Summary of Product Characteristics (SmPC) and the corresponding sections of the Package Leaflet (PL).

Variations should be submitted without delay and should be accompanied by a communication confirming the successful submission of the variation, and specifying the medicinal products involved and the procedure number generated automatically. All of the above should be sent to the following email address: variazioni_brevetto@aifa.gov.it.

It should be noted that the acceptance of variations as AI variations as detailed above, is strictly limited to the specified cases and is to be considered a regulatory approach valid only for Italy. Therefore, it is not immediately applicable to the regulatory authorities of other Member States. In that case, Marketing Authorisation Holders are required to verify how to submit such applications, on a country-by-country basis.