Qualified Person

Article 103 of Directive 2001/83/EC requires marketing authorisation holders to have an appropriately qualified person, responsible for pharmacovigilance, permanently and continuously at their disposal. Volume 9 confirms that the qualified person must be located in the European Economic Area (EEA). The qualified person is responsible for:

* establishing and maintaining a system which ensures that information about all suspected adverse reactions, reported to people within the company and medical representatives, is collected and collated at a single point within the EU;

* preparing reports (in accordance with Article 104, see below) for the competent authorities, in accordance with national guidelines and Volume 9;

* ensuring a full and prompt response to any request from a competent authority for additional information (including information about volume of sales or prescriptions) necessary for a risk/benefit evaluation of a medicinal product.

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