Regulation Update on Pharmacovigilance and Risk Management in the EU

| 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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