81Those rules require that a medicinal product such as Avastin must be subject to a pharmacovigilance system under the control of the EMA in coordination with the competent national agencies for pharmaceutical matters. Under the second paragraph of Article 101(1) of amended Directive 2001/83, ‘[that system] shall be used to collect information on the risks of medicinal products as regards patients’ or public health. That information shall in particular refer to adverse reactions in human beings, arising from use of the medicinal product within the terms of the [MA] as well as from use outside the terms of the [MA], and to adverse reactions associated with occupational exposure’.
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