The Marketing Authorization Holders (MAHs) of medicinal products for human use intended for Italian market, authorised through National or Mutual recognition/Decentralised procedure, 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 atorvastatin calcium trihydrate, 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.

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

The communications should be received by 31/12/2021 to the mailbox:  infocepgmp@aifa.gov.it