Local view for "http://purl.org/linkedpolitics/eu/plenary/2011-02-16-Speech-3-232-000"
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"en.20110216.11.3-232-000"2
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".
There is an alarming increase in the EU of medicinal products which are falsified with regard to their identity, history or source. The directive introduces obligatory safety features for all prescriptive medicinal products and a rapid alert system; harmonised safety features to verify authenticity and identify individual packs, providing tampering evidence for medicinal products subject to prescription (possible exclusion of certain products following a risk assessment); no safety features for medicinal products not subject to prescription, unless a risk assessment demonstrates the risk of falsification and consequently a threat to public health; traceability: there will be a unique identifier for the safety features (e.g. a serialisation number) which allows the authenticity of the product and individual packs to be verified throughout the supply chain up to pharmacy level; in addition, Member States have to set up systems to prevent suspected medicinal products from reaching patients; Internet sales: conditions for the supply of medicinal products to the public are determined by Member States; increased transparency as regards wholesale distributors; penalties applicable to infringements of national provisions must be applied."@en1
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