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2 Amendments of Marina YANNAKOUDAKIS related to 2008/0260(COD)

Amendment 113 #
Marina YANNAKOUDAKIS
Proposal for a directive – amending act
Article 1 – point 3 – point b
Directive 2001/83/EC
Article 11 – paragraph 3
“For the purposes of point (3a) of the first subparagraph, for medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the summary shall include the statement: “This medicinal product is under intensive monitoring.following statement, preceded by the symbol : All suspected adverse reactions should be reported to <name and web-address of the national competent authority>.”
2010/03/15
Committee: ENVI
Amendment 117 #
Marina YANNAKOUDAKIS
Proposal for a directive – amending act
Article 1 – point 3 – point b a (new)
Directive 2001/83/EC
Article 11 – paragraph 3 a (new)
(b a) the following paragraph is added: “This summary of essential information shall be reviewed after the entry into force of a new directive on information to patients, to be proposed by the Commission”:
2010/03/15
Committee: ENVI
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