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 mentioned active substances/ intermediates,  these are covered by the respective CEPs. 

• 2012-025 (suxamethonium chloride)
• 2012-251 (cytarabine)
• 2012-350 (letrozole)
• 2012-147 (carboplatin)
• 2012-066 (dacarbazine)
• 2017-164 (gefitinib)
• 2017-246 (ropivacaine hydrochloride monohydrate)
• 2015-141 (pemetrexed disodium heptahydrate)
• 2019-024 (neostigmine metilsulfate)
• 2018-063 (irinotecan hydrochloride trihydrate)
• 2019-329 (bicalutamide)
• 2020-012 (cisplatin)
• 2020-074 (etoposide)

ONLY in case of positive feed-back, companies should send immediate notification to the AIFA, Medicinal Product Authorization Department (AAM) specifying if alternative manufacturers are available or if the active substance/intermediate manufacturers covered by the a.m. CEPs are the only ones authorized.

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

The communications should be received by 26/11/2022 to the mailbox:  infocepgmp@aifa.gov.it