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…

EMA increase of fees from 1 April 2018

Every year, the European Medicines Agency (EMA)  adjusts its fees on 1 April, in line with the European Union (EU) inflation rate for the previous year. On 1 April 2018 general, non-pharmacovigilance fees payable to EMA by applicants and marketing-authorisation holders (MAH) are increasing by 1.7%. Applications received after the 31 March 2018 will be charged the…

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…