Dietetic supplements production
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New Notification of dietary supplement - Ministry of health

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Procedure

A commercialization of a food supplement is a subject to a notification procedure at the Ministry, which will evaluate the compliance with local regulations to ensure the product safety and the correct information offered to the consumers. The notification must be applied individually for each supplement, at the Ministry of Health. The Ministry evaluates the notification and at the end of the positive evaluation inserts it in the registry of food supplements on the website of the Ministry. In case of reliefs, the Ministry will inform the notifying company, which has 30 days to comply with the requirements by sending a written reply, containing the information specified in the reply form for a Notification of dietary supplement that should be send in the same manner as the notification. In the communications sent by the Ministry to the company of interest it is indicated a code (ex: Code: i5ih2 / 56478) that represent the identification number of the practice, which should be stated in the subject in the appropriate form for subsequent communications with the Ministry in order to allow an easier recognition of the practice.

Who can ask for it?

Persons that operate in the food industry, responsible for commercialization in Italy of the food supplement that will be notified.

What should be send?

A designated form that can be downloaded from the website of the government; a PDF copy of the label of the product that conforms to the one that is used for commercializing , with a resolution of 150 dpi enlarged in ortder to fit to one A4 size; confirmation for the payment; copy of the identity document in case of transmission by PEC

Address:

Viale Giorgio Ribotta, 5 00144 Roma

How long it takes?

90 days.

How much does it costs?

Rate: Euro 160,20

Payment methods:

Bank Transfer.
Holder of the C / C: State Provincial Treasury - Viterbo (VT) ITALY
IBAN: IT 32 Y 07601 032 000000 11,281,011

Subject

Notification for food supplement and product name
Further instructions: swift / bic BPP II TRR

Regulations

  • Dir 2002/46 / EC
  • Legislative Decree 169/2004
  • Regulation 1170/2009 / EC
  • Circular 4075-P of 6 March 2008
  • DM February 14, 1991, as amended, currently DM June 5, 2003