title: [Phytovigilance: A medical requirement and a legal obligation].
abstract: Phytovigilance consists in supervision of side effects and drug interactions consequential to use of herbal medicinal products, herbal food supplements, herbal cosmetics and/or medicinal plants. It includes thus pharmacovigilance applied to phytotherapy, nutrivigilance and cosmetovigilance but also addictovigilance in case of plants, which lead to drug addiction, and toxicovigilance in case of toxic plants. Becoming necessary owing to (acute or chronic) toxicity risks or to drug interactions risks (of pharmacocinetical or pharmacodynamical kind)--as far as it concerns interactions between several associated plants or between a plant and a chemical or biotechnological allopathic medicine--phytovigilance represents moreover a legal obligation. Pharmacovigilance--in case of herbal medicinal products--is indeed becoming mandatory according to title IX of the European directive 2001/83/EC, whereas nutrivigilance is imposed by the European Food Safety Agency (EFSA).
authors.affiliation: EA 4487, centre de recherches en droit et perspectives du droit, faculté des sciences pharmaceutiques et biologiques, université Lille 2, 3, rue du Professeur-Laguesse, BP 53, 59006 Lille, France. Electronic address: helene.lehmann0306@orange.fr.
authors.forename: H
authors.initials: H
authors.lastname: Lehmann
authors.affiliation: EA 7307, centre d'études internationales et européennes (CEIE), faculté de pharmacie, université de Strasbourg, 74, route du Rhin, 67400 Illkirch, France.
authors.forename: J-Y
authors.initials: JY
authors.lastname: Pabst
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence* / Q000592:standards*; D000818:Animals; D019587:Dietary Supplements / Q000009:adverse effects; D004347:Drug Interactions; D005062:European Union; D006801:Humans; D007880:Legislation, Drug; D060735:Pharmacovigilance; D008517:Phytotherapy; D028321:Plant Preparations / Q000009:adverse effects*
chemical_list: D028321:Plant Preparations
keywords: Addictovigilance; CABP; Cosmetovigilance; Cosmétovigilance; Directive 2001/83/CE; Directive 2001/83/EC; Herbal food supplements; Herbal medicinal products; MABP; Materiovigilance; Matériovigilance; Nutrivigilance; Pharmacovigilance; Phytovigilance; Toxicovigilance