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…
Author: AxeRegel
EMA closed from 8 May until 14 May 2018
The European Medicines Agency (EMA) will be closed from 18:30 on Tuesday 8 May until 7:30 on Monday 14 May 2018. EMA
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…
General Data Protection Regulation (GDPR) / Règlement général sur la protection des données (GRPD)
Regulation (EU) 2016/679, the European Union’s (EU) new General Data Protection Regulation regulates the processing by an individual, a company or an organisation of personal data relating to individuals in the EU. This regulation harmonizes data privacy laws across Europe and will be enforced in France on 25 May 2018. It applies if the data…
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…