European Pharmaceutical Legislation

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Chapter: Pharmacovigilance: Risk Management - a European Regulatory View

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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