The European Commission has published the long-awaited Delegated Regulation, setting out the requirements for the future system of medicines verification that must operate in all EU countries.
http://ec.europa.eu/health/files/eudralex/vol-1/reg_2016_161/reg_2016_161_en.pdf
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 thpackaging of medicinal products for human use.
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. L 32/6 EN Official Journal of the European Union 9.2.2016
Scope
1. 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.
You can download the document from HERE.
Source
http://ec.europa.eu/health/files/eudralex/vol-1/reg_2016_161/reg_2016_161_en.pdf
