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Qualified Person for Pharmacovigilance

The European law requires marketing authorization applicants and holders to have permanently and continuously at their disposal a qualified person responsible for pharmacovigilance. The person shall reside in the Community, have appropriate qualification, and shall be responsible for the following:

(a) the establishment and maintenance of a system which ensures that information about all suspected adverse reactions which are reported to the personnel of the company, and to medical representatives, is collected and collated in order to be accessible at least at one point within the Community;

(b) the preparation for the competent authorities of the periodic safety update reports;

(c) ensuring that any request from the competent authorities for the provision of additional information necessary for the evaluation of the benefits and risks afforded by a medicinal product is answered fully and promptly, including the provision of information about the volume of sales or prescriptions of the medicinal product concerned;

(d) the provision to the competent authorities, of any other information relevant to the evaluation of the benefits and risks afforded by a medicinal product, including appropriate information on postauthorization safety studies.

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