The winning supplier must, no later than the start of the agreement, make environmental information available for the medicinal products that are included in the agreement and that are covered by the European Medicines Agency's (EMA's) guidelines1, 2 for environmental risk assessments.
At the request of the contracting authority, or in accordance with an implementation plan for the agreement or similar, the supplier must be able to refer to where environmental information for contracted medicinal products is available to the public. Publicly available environmental information refers to information that is available on a free website without any requirement for 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 EMA's latest guidelines,1, 2 the most recently published FASS guidelines regarding environmental information for medicinal products,2 or another equivalent publicly available model for environmental information.
The special contract term does not cover medicinal products that are exempted from environmental information requirements according to the EMA's guidelines.1, 2 The winning supplier must ensure that environmental information is kept available for the entire term of the contract for these medicinal products.
If the supplier deems that access to the information requested according to the special contract term is missing, the supplier must make reasonable efforts to compile or obtain access to the information. The supplier must be able to explain the efforts that have been made in this regard.
1. See article 8.g of directive 2001/83/EC and chapter 3, section 1 of the Swedish Medical Products Agency's regulations LVFS 2006:11, which entered into force on 30 June 2006.
2. 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.
