Currently, the marketing of dietary supplements is subject to the notification procedure,i.e. the transmission to the Ministry of Health of the template of the label used for marketing. In order to standardize the procedures of notification a Circular of the Ministry of Health of the March 6, 2008, n. 4075-P was issued. The Ministry provides modules to use for both notifications and variations.
Ninety days from the date of receipt of the notification by the Ministry, the principle of tacit consent applied. In these 90 days the Ministry identifies any deficiencies or inaccuracies in the labelling and may require the company to make changes or to provide explanations and / or technical data sheets.
Dietary supplements with labelling in accordance with the regulations may be placed on the market at the same time as the notification of the label to the Ministry, except those coming from third countries, that must wait for the 90 days to expire.
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.