In Italy, the marketing of a dietary/food supplement can only occur after the product has been duly notified to the Ministry of Health, which is the competent authority to assess the correspondence of the formulation and the claims with current local regulations.
In the case of a positive outcome the supplement, subject of the notification, will be included in the Register of dietary supplements available on the website of the Ministry.
In the field of food supplements, Di Renzo Regulatory Affairs engages highly qualified personnel in the chemical, pharmaceutical and food sciences sector, able to provide consulting services on:
- Preliminary examination of the text of the labels and verification of their compliance with current regulations
- Process for notification to the Ministry of Health
- Request for Certificates of Free Sale ( CLV )
- Identification of claims that can be used
- Assistance for imports from European countries and beyond
- Assistance in the preparation of technical and administrative documents for export to Europe and non-EU countries
- Design and development of packaging
- Regulatory up-dates
- Company courses on the relevant regulations
- Authorization procedure for production sites
- Preparation of brochures and leaflets
- Assistance with the process of phytovigilance
- Audits at domestic and foreign manufacturing companies
- Preparation of technical and scientific rationale for dietary supplements containing ingredients derived from plants (botanicals)
- Drafting of Standard Operational Procedures (SOP)
- Assistence for the organic certification