Italy: Request Methods for Free Sale Certification and GMP Declaration

Requesting Free Sale Certificates and Good Manufacturing Practice Declarations for cosmetics were instructed to be sent via certified e-mail, except for the applicants excluded from the obligation. The excluded applicants can send the application via the permitted registered mail.

Although the certified e-mail was intended to be the standard approach, applicants are becoming more aware of the likelihood of system slowdowns caused by impending requests sent by the applicants. Therefore, starting from 14 August 2023, any email requests for Free Sale Certification and GMP Declaration for cosmetics will not be sent by certified email to the PEC address, instead, all applicants will only be instructed on the merits, provided that applicants provide relevant certifications of being excluded to possess a certified e-mail box. Any request applications that not obeying the relevant method will be rejected.

It is in accordance with the Law Decree 185/2009, Article 16 of Paragraph 6, and subsequent amendments that instruct companies in Italy were obliged to hold a certified email address. On the other hand, it is advisable for all applicants to avoid the possibility of re-using or recovering the tariff and paid stamp duty for the requests.

Source: Ministero della Salute