In Italy, the marketing of a food supplement can only occur after the product has been duly notified to the Ministry of Health. The Ministry of Health is obligated to object to the notified label within 90 days, and the food supplement is permitted market access during this period as long as it conforms to regulations. Products from outside the EU/Italy will need to wait past the 90 day tacit consent period before importing.
Supplements, for which the registration procedure has been completed positively, are inserted into a public register where they are also identified with a specific authorization code number.
If the Ministry considers that the product represents a health hazard, it will organize for its withdrawal from the market by sending a simultaneous request to the local Department of Health which has territorial jurisdiction, for appropriate investigations. The company is required to give timely and formal assurance to the Ministry that they have complied with the requirements.
NHP Consulting will prepare the required regulatory documentation to achieve market compliance for food supplements in Italy.