LEGISLATION ON HERBAL AND HEALTH PRODUCTS

The course aims to provide basic knowledge of the regulatory aspects of the herbal and complementary sectors. The course is organized in frontal lessons with  active learning practices. The student will acquire a general knowledge of the rules governing manipulation, the transformation and production of herbal products in their various uses (pharmaceutical, health, cosmetic, food), as well as their presentation and marketing in herbal medicine and in pharmaceutical businesses. Information will also be acquired on national and European regulations concerning the sectors complementary items of interest to the herbalist (cosmetic products, foods and foods for specific groups, food supplements, enriched foods, Novel Foods).

At the end of the course the student will be able to:

 - Develop a nutritional label for a nutraceutical product;

 -Recognize the formal correctness or inaccuracies in the labeling of food and nutraceutical products;

-Identify the correct regulatory procedures in the sector;

-Compile and interpret a phytovigilance form;

-Differentiate the legislation of different medicinal, nutraceutical and health products;

-Provide regulatory consultancy to manufacturing and commercial companies in the sector.

Frontal lessons. If the teaching is given in a mixed or remote mode, the necessary changes with respect to what was previously stated may be introduced, in order to respect the program envisaged and reported in the syllabus.

No prerequisites are required for class attendance

LEGISLATION OF THE HERBAL SECTOR

Notes on national and supranational legislation

The national normative sources and their hierarchical placement; The main normative sources: ordinary laws and acts having the force of law (legislative decrees and legislative decrees), regional laws, regulations, single texts and codes, circulars. Institutional health bodies: Ministry of Health, Higher Council of Health, Higher Institute of Health, Italian Medicines Agency. Supranational legislation: acts of the European Union, United Nations Organization, European Union, European Medicines Agency, Food and Drug Administration, World Health Organization. Definition and development of medicines. Definition of medicinal product, classification of medicinal products; Legislative Decree 219/06; Relationship between medicines and complementary sectors of health interest; Legislation on the production and marketing of medicines: AP (GMP); AIC (related procedures, application for registration). Pharmacovigilance.

 Regulatory framework for plant-based products and their derivatives

Herbal medicine and herbal medicine; Herbal medicines (prepackaged products and extemporaneous preparations); Regulations on phytotherapeutic products: Community Directive 2004/24; Traditional herbal medicine and herbal medicine (traditional use; well-established use); Community monographs and community list; Special provisions relating to traditional herbal medicines; Committee for Herbal Medicines (HMPC). Norms on officinal plants: law 6 January 1931, n. 99 "Discipline of the cultivation, harvesting and trade of medicinal plants"; Royal Decree 26 May 1932, n. 772 "List of plants declared officinal"; Regional law 23 May 1994, n. 9 "Rules for the exercise of herbal professional activities"; Legislative Decree 21 May 2018, n. 75 “Consolidated law on the cultivation, harvesting and first processing of medicinal plants”. Phytovigilance: epicenter, vigierbe, phytotherapeutic interactions and conventional drugs.