2 Amendments of Åsa WESTLUND related to 2008/0257(COD)
Amendment 14 #
Proposal for a regulation – amending act
Recital 2 a (new)
Recital 2 a (new)
(2a) The pollution of waters and soils with pharmaceutical residues is an emerging environmental problem and an emerging public health concern. Actions to reduce the potentially harmful impacts on the European environment especially on surface water, groundwater and drinking water and public health are needed. Therefore, measures should also be taken to monitor the adverse environmental effects of medicinal products on public health and the environment. This must not lead to the withdrawal of the authorisation for drugs necessary for treating life-threatening or serious diseases.
Amendment 68 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation EC/726/2004
Article 28f a (new)
Article 28f a (new)
Article 28fa Environmental supervision and protection Member States shall appoint one or several national authorities to monitor the adverse environmental effects of medicinal products on public health or the environment. 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 European Medicines Evaluation Agency and to the competent authority. The Agency shall, upon receiving such information, assess whether the risk-benefit balance remains favourable, taking into account the new findings. This must not lead to the withdrawal of the authorisation for drugs necessary for treating life-threatening or serious diseases.