The Marketing Authorization Holders (MAHs) of medicinal products for human use intended for Italian market and/or Italian manufacturers  of medicinal products to be exported,  are requested to verify, as a matter of urgency, if in their medicinal products containing  the active substance/ intermediate irbesartan, this is covered by the above  mentioned CEP,  in order to undertake any  consequent necessary actions for which they are responsible.

Companies should communicate ONLY if the active substance /intermediate manufacturer covered by the a.m. CEP is the only one authorized, therefore in the absence of alternative manufacturers, and proceed with the appropriate variation application for the replacement of the manufacturer.

It is required to specify the European procedure code for medicinal products authorized by  Mutual Recognition procedure.

The communications should be received by 28.6.2021 to the mailbox: infocepgmp@aifa.gov.it