LEGISLATION ON HERBAL AND HEALTH PRODUCTS

Regulations about products obtained from plants and derivatives; Natural herbal medicine and herbal medicine. Phytochemicals: definition according to the law 219/2006; Manufacturing authorization and authorization for marketing; Authorization for marketing: the procedures; The Committee for Herbal Medicinal Products (HMPC); The National Pharmacovigilance System; Supervision and sanctions; Preparation of galenic products based on natural products; Definition and classification of cosmetic products according to the Law 1223/2009; Presentation of a cosmetic: authorized claims, labeling; minimum duration and PAO;INCI and CTFA classification; Rules relating to the production and marketing of a cosmetic product; valuation parameters on cosmetic products; Informative documentation on cosmetics: the safety assessment; Report on the safety of the cosmetic product; Specific prohibitions on production; Foods: definition and regulatory aspects; The law 258/97: the novel foods; Regulation n ° 608/2004; Regulation (EC) 1924/2006 on nutrition and health on foods; EFSA: definitions; The Regulation 432/2012 and the approved claims on foods; Value of claims on foods; procedure for insertion of new claims; Foods intended for particular nutritional uses (Law 111/1992); Classification and regulations on specific subclasses; The changes introduced by Law 609/2013; Food supplements and the Law 169/2004; Classification, Production, authorization for marketing, packaging and labeling; Supplements made from ingredients made from plants or derivatives; The BELFRIT project.

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2. V. Silano, M. Silano, Prodotti di origine vegetale, Tecniche Nuove, 2006
3. F.U.I. XII Ed. ed aggiornamenti
4. P. Minghetti: Legislazione Farmaceutica, ottava edizione, CEA, Milano (consultazione su Cosmetici, Codice dei Medicinali, DL.vo sugli Integratori)
5. Materiale didattico del docente