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How to Notify Special Medical Foods in Italy

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Notifying Special Medical Foods in Italy

Notify Special Medical Foods in Italy

Special medical foods are formulated food products used to manage patients’ diets under medical supervision, including infants. To ensure product safety and consumer protection, these foods must be notified to the Italian Ministry of Health before being placed on the market. This post will explain the process you need to follow in order to notify special medical foods in Italy, including who can apply, how to apply, and the requirements for compliance with the regulations.

Read also “Food supplements in Italy”

Who Can Apply?

The FBO (food business operator) is responsible for notifying special medical foods to the Italian Ministry of Health. Italian FBO accesses the notification system through the “portale imprese” (business portal), while European or San Marino FBO can access the system after requesting the appropriate access key from the office 4 by sending the completed self-certification form and the required documentation translated into Italian and legalized.

How to Apply?

To notify special medical foods, the FBO must submit an electronic notification to the Italian Ministry of Health through the “Alimenti Soggetti a Notifica” system. The notification must be done separately for each food product. The Ministry will evaluate the conformity of the product to the applicable laws to ensure product safety and provide consumers with accurate information. In case of issues, the Ministry informs the FBO through the system’s dedicated section.

Requirements for Compliance – Notify Special Medical Foods in Italy

The FBO has 30 days to respond to the Ministry’s requests and comply with them, as outlined in the manual, including attaching a modified label if the request includes a change to the label. The state of the notification must always be viewed within the NSIS telematic system. AFMS must comply with the Special Medical Foods Guidelines (July 2022 revision) and be notified for placing them on the market. AFMS for metabolic diseases or cystic fibrosis patients is available through the Italian National Health Service.


In conclusion, notifying special medical foods is mandatory before they can be placed on the market in Italy. The operator of the food sector must comply with the applicable laws, and the Italian Ministry of Health ensures the conformity of the product for consumer safety. Notification can be done online, and the Ministry’s system must be used to check the state of the notification. By following the regulations, the FBO can ensure product safety and consumer protection.

Do you need help? Write to: chiedi@eliopalumbieri.it

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Elio Palumbieri

Sono un avvocato esperto in diritto agroalimentare e filiere agroalimentari sostenibili. Accompagno le imprese in ogni aspetto di regulatory compliance fornendo consulenza progettuale finalizzata alla crescita sostenibile, alla certificazione e alla corretta comunicazione dei risultati.

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