With the issuance of the Directorial Decree of December 17, 2024, the guidelines for the proper labeling of PMC products, regulated by D.P.R. n. 392 of October 6, 1998, have been approved.
The objective of these guidelines is to ensure the correct labeling of PMCs, in order to protect the health of consumers and professional users through responsible and informed purchasing and use, as well as help authorization holders avoid violations of authorization conditions, which could be subject to criminal sanctions under Article 14, paragraph 1 of Legislative Decree 179/2021.
Labeling principles apply from the start of the marketing authorization process until the expiration of the authorization.
To learn more about the principles of proper labeling, download the decree: https://www.trovanorme.salute.gov.it/norme/renderNormsanPdf?anno=2024&codLeg=104505&parte=1%20&serie=null
