In order to receive [points or discounts per position], the supplier must submit information in its tender for [state relevant positions/medicinal product that shows that environmental information has been obtained and is publicly available. Publicly available environmental information refers to information that is available on a free website without requiring membership, payment etc.
The environmental information must at least include details regarding persistence, bioaccumulation, toxicity and environmental risk. It must be compiled in accordance with the European Medicines Agency's (EMA's) latest guidelines1 the most recently published FASS guidelines regarding environmental information for medicinal products,2 or another equivalent publicly available model for environmental information.
If the award criterion is met for one or more of the medicinal products included in the tender, the winning supplier must keep environmental information for the medicinal products in question available according to this requirement for the entire duration of the agreement.
The award criterion does not apply to medicinal products that are covered by the European Medicines Agency's (EMA') guidelines.1, 2 Neither does the requirement apply to medicinal products that are exempted from environmental information requirements according to the same guidelines.
1. European Medicines Agency, 2006. Committee for medicinal products for human use (CHMP). Guideline on the environmental risk assessment of medicinal products for human use. Ref EMEA/CHMP/SWP/4447/00 corr 2, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500003978.pdf.
2. Environmental classification of pharmaceuticals at www.fass.se Guidance for pharmaceutical companies 2012, https://www.fass.se/pdf/Environmental_classification_of_pharmaceuticals-120816.pdf.
