On April 7, 2016, the French National Security Agency for Medicines and Health Products ("ANSM") launched a public consultation on a draft ministerial order setting out pharmacovigilance best practices. Further to the amendment of the French regulations necessary for the implementation of Directive 2012/26/EU of October 25, 2012, amending Directive 2001/83/EC as regards pharmacovigilance and of Commission Implementing Regulation (EU) No 520/2012 on the performance of pharmacovigilance, the ANSM is now updating the French best pharmacovigilance guidelines, currently based on a 2005 ministerial order, with consideration of the European Medicines Agency ("EMA") good pharmacovigilance practice guidelines ("GVP"). Once adopted, the new French best practices order will apply in addition to EMA's GVP and will detail procedures at the national level. The consultation relates to issues including the role of the ANSM, the role of health care professionals, patients, Marketing Authorization holders and operators, and the Technical Committee on Pharmacovigilance, as well as the national pharmacovigilance inquiry procedure and the communication good practice on safe drug use. Comments are due June 15, 2016.
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