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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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Article 1Subject matter
This Regulation lays down:
(a)
the characteristics and technical specifications of the unique identifier that enables the authenticity of medicinal products to be verified and individual packs to be identified;
(b)
the modalities for the verification of the safety features;
(c)
the provisions on the establishment, management and accessibility of the repositories system where the information on the safety features shall be contained;
(d)
the list of medicinal products and product categories subject to prescription which shall not bear the safety features;
(e)
the list of medicinal products and product categories not subject to prescription which shall bear the safety features;
(f)
the procedures for the notification to the Commission by national competent authorities of non-prescription medicinal products judged at risk of falsification and prescription medicinal products not deemed at risk of falsification in accordance with the criteria set out in Article 54a(2)(b) of Directive 2001/83/EC;
(g)
the procedures for a rapid evaluation of and decision on the notifications referred to in point (f) of this Article.
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