4 Amendments of Rareș-Lucian NICULESCU related to 2008/0261(COD)
Amendment 70 #
Proposal for a directive – amending act
Recital 7
Recital 7
7. In order to take account of new risk profiles, while at the same time ensuring the functioning of the internal market for medicinal products, safety features designed to ensure the identification, authentication and traceability of prescription and over-the-counter medicinal products should be established at Community level. When introducing obligatory safety features for prescription and over-the-counter medicinal products, due account should be taken of the particularities of certain products or categories of products, such as generic medicines. This includes the risk of falsifications in view of their price and past incidences in the Community and abroad, as well as the consequences of falsifications for public health in view of the specific characteristics of the products concerned or of the severity of the conditions intended to be treated.
Amendment 96 #
Proposal for a directive – amending act
Recital 11 a (new)
Recital 11 a (new)
(11a) European citizens should be made aware of the risks of purchasing medicinal products from illegal suppliers. An information campaign should be organised by the Member States and at EU level. The Commission and Member States should adopt measures to make the public aware of the risks of purchasing medicinal products over the internet.
Amendment 118 #
Proposal for a directive – amending act
Recital 18 a (new)
Recital 18 a (new)
(18a) The Member States should collaborate, within Europol and elsewhere, in enforcing existing rules designed to restrict the illegal activities of those supplying medicinal products over the internet.
Amendment 321 #
Proposal for a directive – amending act
Article 1 – point 13 – point b
Article 1 – point 13 – point b
Directive 2001/83/EC
Article 80 – point i – paragraph 2
Article 80 – point i – paragraph 2
Moreover, in cases where these infringements or suspected infringements relate to a falsified medicinal product, the holder of the marketing authorisation or of the trademark that has been falsified shall be informed.’ In their turn, holders shall inform the other operators along the supply chain for the medicinal product concerned regarding the infringements or suspected infringements.