Article 8c Specific provisions for pharmaceutical substancesF1

Pursuant to Article 16(9) of Directive 2000/60/EC, and where appropriate on the basis of the outcome of its 2013 study on the risks posed by medicinal products in the environment and of other relevant studies and reports, the Commission shall, as far as possible within two years from 13 September 2013 develop a strategic approach to pollution of water by pharmaceutical substances. That strategic approach shall, where appropriate, include proposals enabling, to the extent necessary, the environmental impacts of medicines to be taken into account more effectively in the procedure for placing medicinal products on the market. In the framework of that strategic approach, the Commission shall, where appropriate, by 14 September 2017 propose measures to be taken at Union and/or Member State level, as appropriate, to address the possible environmental impacts of pharmaceutical substances, particularly those referred to in Article 8b(1), with a view to reducing discharges, emissions and losses of such substances into the aquatic environment, taking into account public health needs and the cost-effectiveness of the measures proposed.