• Pharmaceutical Consulting | Consulenza Farmaceutica | Di Renzo Regulatory Affairs
  • Pharmaceutical Consulting | Consulenza Farmaceutica | Di Renzo Regulatory Affairs
  • Pharmaceutical Consulting | Consulenza Farmaceutica | Di Renzo Regulatory Affairs
  • Pharmaceutical Consulting | Consulenza Farmaceutica | Di Renzo Regulatory Affairs
  • Pharmaceutical Consulting | Consulenza Farmaceutica | Di Renzo Regulatory Affairs
  • Pharmaceutical Consulting | Consulenza Farmaceutica | Di Renzo Regulatory Affairs
  • Pharmaceutical Consulting | Consulenza Farmaceutica | Di Renzo Regulatory Affairs
Home Supplements Notification

Notification

Currently, their marketing is subject to the notification procedure, i.e. the transmission to the Ministry of Health of the label templates used for marketing. In order to standardize the procedures for notification the Circular of the Ministry of Health March 6, 2008, No 4075-P has been issued. Moreover, the Ministry provides the forms to be completed for notifications.

Ninety days after the date of receipt of the notification, the principle of tacit consent applies. Within these 90 days, the Ministry, identifying any deficiencies or inaccuracies in the labelling, can require the company to make changes or to provide explanations and / or technical specifications. Dietary supplements with compliant labels can be marketed together with the notification of the label to the Ministry, who must wait until after the ninety days

If the Ministry deems that the product constitutes a health hazard, it will arrange for the withdrawn from the market and send the request to the authorised local Health Department for appropriate investigation. The company concerned is required to give timely and formal assurance to the Ministry that they have fulfilled the requirements.

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