European Pharmaceutical Legislation
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In November 2005 new European legislation came into force including a number of provisions aimed at strengthening pharmacovigilance.
EUROPEAN PHARMACEUTICAL
LEGISLATION
In
November 2005 new European legislation came into force including a number of
provisions aimed at strengthening pharmacovigilance. Specifically, Article 8(3)
(ia) of Directive 2001/83/EC requires applicants for marketing authorisations
to submit ‘a detailed description of the pharmacovigilance and where
appropriate, of the risk management systems which the applicant will
introduce’. The descrip-tion of the pharmacovigilance system is
company-specific, encompassing inter alia pharmacovigilance databases, and
systems for collecting and reporting ADRs. The requirement for submission of a
descrip-tion of the risk management system is in contrast product-specific.
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