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Regulatory Focus™ > News Articles > Regulation Update on Pharmacovigilance and Risk Management in the EU

Regulation Update on Pharmacovigilance and Risk Management in the EU

Posted 01 September 2011

The World Health Organization (WHO) defines "pharmacovigilance" as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.1

Title IX of Directive 2001/83/EC relating to medicinal products for human use (Articles 101 to 108) covers issues related to pharmacovigilance. According to the directive, the objective of a functioning pharmacovigilance system should be to safeguard public health without impeding the free movement of safe medicinal products within the EU.2

 

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