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
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Inquests are something which affect a vast range of NHS and private organisations, as well as individual clinicians, and so we provide a brief overview of recent developments as well as a couple of key potential changes to come.
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