Author: AxeRegel

AxeRegel is a consultancy company offering regulatory and pharmaceutical services for the life sciences industry through the lifecycle of their products. Our mission is to provide exceptional regulatory and pharmaceutical consulting services at the right time to maximise our clients’ business potential. Visit www.axeregel.com for more information. AxeRegel 17-21 rue Saint Fiacre 75002 Paris France Tel: +33 (0)1 70 98 31 60 Email: contact@axeregel.com

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…

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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…

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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…

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