5 Amendments of Michail TREMOPOULOS related to 2008/0260(COD)
Amendment 33 #
Proposal for a directive – amending act
Recital 5 a (new)
Recital 5 a (new)
(5a) Pharmaceutical substances are biologically active in humans due to their inherent properties and are often engineered so that they remain unchanged during their passage through the human body. This stability means that they also persist outside the human body, which can create environmental problems, which in turn can affect public health. In order to address the pollution of waters and soils with pharmaceutical residues, undesirable effects on the environment should be included in the assessment of the risk-benefit balance. Moreover, competent authorities should monitor adverse environmental effects of medicinal products with a view to reassessing the risk-benefit balance.
Amendment 80 #
Proposal for a directive – amending act
Article 1 – point 1 – point a a (new)
Article 1 – point 1 – point a a (new)
Directive 2001/83/EC
Article 1 – point 13 a (new)
Article 1 – point 13 a (new)
(aa) The following point is inserted: “(13a) Adverse environmental effect: An undesirable effect on the environment or on public health via the environment of a medicinal product or its degradation products”
Amendment 89 #
Proposal for a directive – amending act
Article 1 – point 1 – point (c a) (new)
Article 1 – point 1 – point (c a) (new)
Directive 2001/83/EC
Article 1 – point 28 a (new)
Article 1 – point 28 a (new)
(ca) point 28a is replaced by the following: “(28a) Risk-benefit balance: An evaluation of the positive therapeutic effects of the medicinal product in relation to the risks defined in point 28 […].”
Amendment 101 #
Proposal for a directive – amending act
Article 1 – point 2 – point -a (new)
Article 1 – point 2 – point -a (new)
Directive 2001/83/EC
Article 8 – paragraph 3 – point (i) – indent 2 a (new)
Article 8 – paragraph 3 – point (i) – indent 2 a (new)
(-a) a new indent is inserted after the second indent in point (i); “– ecotoxicological tests, and”
Amendment 265 #
Proposal for a directive – amending act
Article 1 – point 24 a (new)
Article 1 – point 24 a (new)
Directive 2001/83/EC
Article 119 a (new)
Article 119 a (new)
24a. The following Article is inserted: “Article 119a Environmental monitoring Member States shall appoint one or several authorities to monitor adverse environmental effects of medicinal products. If one of these authorities identifies an environmental risk that is higher than that indicated in the evaluation pursuant to Article 8(3)(ca), or if it finds new adverse environmental effects, it shall forthwith transmit all findings to the competent authority. The competent authority shall, upon receiving such information, assess whether the risk- benefit balance remains favourable when taking into account the new findings.”