Medlemsstaterne sikrer, at deres kompetente myndigheder sender relevante oplysninger til hinanden og til Kommissionen om alvorlige bivirkninger og uønskede hændelser for at sikre, at der træffes hensigtsmæssige foranstaltninger.
Member States shall ensure that their competent authorities communicate to each other and to the Commission such information as is appropriate with regard to serious adverse reactions and events, in order to guarantee that adequate actions are taken.