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Commission Delegated Regulation (EU) 2016/161Show full title
Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (Text with EEA relevance)
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CHAPTER X LISTS OF DEROGATIONS AND NOTIFICATIONS TO THE COMMISSION
Article 45Lists of derogations from bearing or not bearing the safety features
1.The list of medicinal products or product categories subject to prescription which shall not bear the safety features are set out in Annex I to this Regulation.
2.The list of medicinal products or product categories not subject to prescription which shall bear the safety features are set out in Annex II to this Regulation.
Article 46Notifications to the Commission
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.
Article 47Evaluation of the notifications
Where, following a notification as referred to in Article 46, the Commission or a Member State considers, on the basis of casualties or hospitalisations of citizens of the Union due to exposure to falsified medicinal products, that rapid action is required to protect public health, the Commission shall asses the notification without delay and at the latest within 45 days.
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