Tighter EU rules on pharmacovigilance for biologicals

Author(s): GaBI Journal Editor

Received: 27 March 2012; Accepted: 22 May 2012 The new EU pharmacovigilance legislation which comes into force in July 2012 will include a tightening of requirements relating to product information and identification, as well as the regulations surrounding biosimilars and automatic substitution by pharmacists. The new regulations will provide a legal framework for patients to report adverse events […]

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