4 Amendments of Jo LEINEN related to 2008/0261(COD)
Amendment 55 #
Proposal for a directive – amending act
Recital 3 a (new)
Recital 3 a (new)
(3a) Within three years of the entry into force of this Directive, the Commission should present to the European Parliament and the Council an assessment report providing detailed data on the extent and sources of counterfeit medicinal products in the legal supply chain in the Union.
Amendment 167 #
Proposal for a directive – amending act
Article 1 – point 2 a (new)
Article 1 – point 2 a (new)
Directive 2001/83/EC
Article 2 – paragraph 3 a (new)
Article 2 – paragraph 3 a (new)
(2a) In Article 2, the following paragraph 3a is inserted after paragraph 3: 3a. The provisions of this Directive shall be without prejudice to the right of the Member States to restrict or prohibit trading in prescription medicinal products over the Internet.
Amendment 212 #
Proposal for a directive – amending act
Article 1 - point 8
Article 1 - point 8
Directive 2001/83/EC
Article 54 - point o
Article 54 - point o
(o) safety features making it possible to ascertain identification, authenticity and traceability of medicinal products, other than radiopharmaceuticals, subject to medical prescription as defined in Title VI. Those safety features shall be applied without discrimination through marketing channels.
Amendment 322 #
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.’ and shall inform the appropriate bodies if he becomes aware or suspects that counterfeit products have infiltrated the supply chain.'