Notifications to the Commission
Article 46
1. National competent authorities shall notify the Commission of non-prescription medicinal products which they judge to be at risk of falsification as soon as they become aware of such risk. For that purpose, they shall use the form set out in Annex III to this Regulation. 2. National competent authorities may inform the Commission of medicinal products which they deem not to be at risk of falsification. For that purpose, they shall use the form set out in Annex IV to this Regulation. 3. For the purposes of the notifications referred to in paragraphs 1 and 2, national competent authorities shall conduct an assessment of the risks of and arising from falsification of such products taking into account the criteria listed in Article 54a(2)(b) of Directive 2001/83/EC. 4. When submitting to the Commission the notification referred to in paragraph 1, national competent authorities shall provide the Commission with evidence and documentation supporting the presence of incidents of falsification.