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)
Modified by
  • Commission Delegated Regulation (EU) 2021/457of 13 January 2021amending Delegated Regulation (EU) 2016/161 as regards a derogation from the obligation of wholesalers to decommission the unique identifier of products exported to the United Kingdom(Text with EEA relevance), 32021R0457, March 17, 2021
  • Commission Delegated Regulation (EU) 2021/1686of 7 July 2021amending 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), 32021R1686, September 21, 2021
  • Commission Delegated Regulation (EU) 2022/315of 17 December 2021amending Delegated Regulation (EU) 2016/161 as regards the derogation from the obligation of wholesalers to decommission the unique identifier of medicinal products exported to the United Kingdom(Text with EEA relevance), 32022R0315, February 28, 2022
Commission Delegated Regulation (EU) 2016/161of 2 October 2015supplementing 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) CHAPTER ISUBJECT MATTER AND DEFINITIONS
Article 1Subject matterThis 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.
Article 2Scope1.This Regulation applies to:(a)medicinal products subject to prescription which shall bear safety features on their packaging pursuant to Article 54a(1) of Directive 2001/83/EC, unless included in the list set out in Annex I to this Regulation;(b)medicinal products not subject to prescription included in the list set out in Annex II to this Regulation;(c)medicinal products to which Member States have extended the scope of application of the unique identifier or of the anti-tampering device in accordance with Article 54a(5) of Directive 2001/83/EC.2.For the purposes of this Regulation, where reference is made to the packaging in a provision of this Regulation, the provision shall apply to outer packaging or to the immediate packaging if the medicinal product has no outer packaging.
Article 3Definitions1.For the purposes of this Regulation, the definitions in Article 1 of Directive 2001/83/EC shall apply.2.The following definitions shall apply:(a)"unique identifier" means the safety feature enabling the verification of the authenticity and the identification of an individual pack of a medicinal product;(b)"anti-tampering device" means the safety feature allowing the verification of whether the packaging of a medicinal product has been tampered with;(c)"decommissioning of a unique identifier" means the operation changing the active status of a unique identifier stored in the repositories system referred to in Article 31 of this Regulation to a status impeding any further successful verification of the authenticity of that unique identifier;(d)"active unique identifier" means a unique identifier which has not been decommissioned or which is no longer decommissioned, and which has not been identified as a "non-Union pack" as referred to in Article 36, point (p);(e)"active status" means the status of an active unique identifier stored in the repositories system referred to in Article 31;(f)"healthcare institution" means a hospital, in- or outpatient clinic or health centre.
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