Food supplements containing melatonin

Melatonin is an hormone secreted naturally during the night. Among other things, melatonin promotes sleep, modules mood and the immune system, regulates the body temperature and the intestinal motricity. In France, melatonin is used in medicinal products, extemporaneous preparations and food supplements. Since the implementation of the Nutrivigilance scheme in 2009 and until May 2017, ANSES…

France updates its GVPs

On February 5, 2018 the French National Security Agency for Medicines and Health Products (ANSM) published an updated version of its Good Pharmacovigilance Practices (GVP). France GVP were first published on 2005 and then updated on 2011. This new text includes the substantial modifications that have occured on the French legislation since then and harmonises…

Parabens – Is there a risk by taking medicinal products containing them?

Parabens are preservatives which avoid microbiological contamination of drug products (by mushrooms or microorganisms) and stop the degradation of active substances (which diminishes the medicinal product efficacy). Parabens are present in certain foods, cosmetics and medicinal products. Their type and concentration are different depending on the concerned product. They are esters of the para-hydroxybenzoic acid…

EU Clinical Trials Register online

The EU Clinical Trials Register was launched on 22 March 2011 by the European Medicines Agency (EMA). The online register gives for the first time public access to information on clinical trials for medicines authorized in the 27 EU Member States, Iceland, Liechtenstein and Norway. The register contains clinical trials from the industry and those…