The online service "Prima Commercializzazione" allows pharmaceutical companies holding authorization for the marketing of medicinal products for human use to communicate to AIFA the actual marketing date of the medicinal products in the national territory, pursuant to Article 34, paragraph five of Legislative Decree 24 April 2006, n. 219.

For packages of medicines in Class C, Cnn, and Cbis, the online service allows communication to AIFA, in addition to the date of first marketing, also the public price and the ex-factory price, as well as the image of the package.

The service is accessible to authorized users of pharmaceutical companies through the Online Services Portal after authentication via SPID, CNS, CIE, and Login eIDAS or, in residual cases (e.g., non-EU users), through username and password credentials.

For each pharmaceutical company, identified by a SIS Code, the following user profiles are provided:

• Manager: views and manages only the practices entered by the user themselves, within the SIS Code for which they are enabled;
• Administrator: views and manages all practices related to the SIS Code for which they are enabled and the reassignment of practices to another user.

The user already registered with AIFA's online services must request access to the "First Marketing" service through the "Profile Management for Already Registered Users" application.

The enabling/disabling of users to the "First Marketing" service must be carried out by the Corporate User Approver (CUA) of each pharmaceutical company through the "Autorizzazione utenze aziendali - AUA e Approvatori Regionali" service.

The online communication of first marketing dates replaces the previous certified mail (PEC) channel.

It is specified that temporary and permanent cessations of the marketing of a medicinal product must be communicated by pharmaceutical companies through the online service "Medicinal Shortages".

Furthermore, it is emphasized that the online first marketing service should not be used to communicate a resumption of marketing following a cessation of marketing. The resumption of marketing operation must instead be carried out through the online service "Medicinal Shortages".

Finally, for marketing delays, the company must send a PEC to AIFA at the address protocollo@pec.aifa.gov.it notifying them of the delay, and then, when known, the new first marketing date must be communicated to AIFA through the online first marketing service using the correction function and providing evidence of the reason in the correction notes themselves.

This correction function can also be used in the case of material errors made in the communication of the first marketing date and, limited to Class C, Cnn, and Cbis drugs, the prices; it should not be used to communicate price changes for these classes of drugs.

Any requests for clarification from pharmaceutical companies regarding the data can be sent to AIFA at the email address taskforce.bdf@aifa.gov.it, taking care to specify in the subject of the email "Online First Marketing Service – SIS code".

Technical issues and/or malfunctions of the online service should be reported to the Agency's HelpDesk.