Available environmental information for medicinal products
Level: Core
The purpose is to increase available information regarding the inherent environmental impact of medicinal products and the environmental risks in connection with the use of contracted medicinal products during the term of the agreement. It is important that environmental information is available.
Details
- Type:
- Special contract terms
- ID:
- 11368
- Group:
- Medicinal Products
Criterion text
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.
Proposed follow-up
In order to prove that the requirement is met, the supplier can refer to various websites, such as www.ema.europa.eu, www.fass.se, or show in some other way that the special contract term is met.
Check that the environmental information is publicly available throughout the contract period and that it contains the environmental information demanded in the requirement.
Suppliers that make use of the possibility to account for and explain efforts that have been made to improve the availability of environmental information are able to meet this special contract term.
Information about the criterion
This special contract term can be applied separately or together with the Available environmental information for medicinal products award criterion at the spearhead level when it is considered relevant with regards to risk (Requirement ID 11222). For more information, see the implementation manual.
It is in the interests of the contracting authorities and the general public that suppliers should make environmental information for the contracted medicinal products available to the public. However, not all suppliers that submit tenders may be in the same situation, and they may have different circumstances when implementing this special contract term. The possibility to account for and explain measures that have been taken in order to improve the availability of environmental information may thus mean that the special contract term has been implemented. Examples of measures that can be taken are:
Publicly available environmental information refers to information that is available on a free website without any requirement for membership, payment etc.
The environmental information can be used, for example, in the work of pharmaceutical committees or as a basis for assessing the follow-up work of contracting authorities regarding contracted medicinal products.
According to article 8(3) of directive 2001/83/EC, the environmental risks of medicinal products for human use are defined as 'any risk of undesirable effects on the environment.' The European Commission's strategy for managing medicinal products in the environment highlights that there is a need for more environmental information and an improved environmental risk assessment.4
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.
3. Environmental classification of pharmaceuticals at www.fass.se Guidance for pharmaceutical companies 2012, https://www.fass.se/pdf/Environmental_classification_of_pharmaceuticals-120816.pdf.
4. European Union Strategic Approach to Pharmaceuticals in the Environment. Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee. Brussels, 11.3.2019 COM (2019) 128 final.
Versions history
The version date indicates when the sustainability criterion was created or last updated. Last reviewed dated tells when we last checked that the sustainability criterion still is relevant.
- Current ID
- 11368
- Version date
- 2019-10-23