European Pharmacovigilance

FOR MEDICINAL PRODUCTS AUTHORISED BY NATIONAL OR MUTUAL RECOGNITION LICENSING PROCEDURES—DIRECTIVE 2001/83/EC

Title IX of Directive 2001/83/EC deals with pharmacovigilance obligations imposed on the Agency, the Commission, marketing authorisation holders and the Member States for medicinal products authorised through national and mutual recognition procedures. Article 102 explains that:

In order to ensure the adoption of appropriate regulatory decisions concerning the medicinal products authorized within the Community, having regard to information obtained about adverse reactions to medicinal products under normal conditions of use, the Member States shall establish a pharmacovigilance system. This system shall be used to collect information useful in the surveillance of medicinal products, with particular reference to adverse reactions in human beings, and to evaluate such information scientifically.

Such information shall be collated with data on consumption of medicinal products.

This system shall also take into account any available information on misuse and abuse of medicinal products which may have an impact on the evaluation of their benefits and risks.

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