Commission Delegated Regulation (EU) 2021/1686 of 7 July 2021 amending Delegated Regulation (EU) 2016/161 as regards the evaluation of notifications by national competent authorities to the Commiss...

II (Non-legislative acts) REGULATIONS COMMISSION DELEGATED REGULATION (EU) 2021/1686 of 7 July 2021 amending Delegated Regulation (EU) 2016/161 as regards the evaluation of notifications by national competent authorities to the Commission and the inclusion of cicatrizants with ATC code D03AX and pharmaceutical form fly larvae in the list of medicinal products that shall not bear the safety features (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (1), and in particular Article 54a(2), points (b) and (c), thereof, Whereas: (1) Article 54a(1) of Directive 2001/83/EC provides that medical products subject to prescription are to bear the safety features referred to in Article 54, point (o), of that Directive, unless they have been listed in accordance with the procedure pursuant to Article 54a(2), point (b), of that Directive. That list is to be established considering the risk of and the risk arising from falsification relating to medicinal products or categories of medicinal products applying the criteria set out in Article 54a(2), point (b), of Directive 2001/83/EC. (2) Article 47 of Commission Delegated Regulation (EU) 2016/161 (2) provides that where, following a notification as referred to in Article 46 of that...