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Call 2011: Tenders

Call for tender n° EAHC/2011/Health/12 concerning a study on the risks of environmental effects of medicinal products


The new pharmacovigilance legislation (Directive 2010/84/EU and Regulation (EU) No 1235/2010) which will become applicable in July 2012, acknowledges that the pollution of waters and soils with pharmaceutical residues is an emerging environmental problem. Recital 3 in the Regulation (EU) No 1235/2010 and recital 6 of the Directive call upon the Member States to consider measures to monitor and evaluate the risk of environmental effects of such medicinal products, including those which may have an impact on public health. In addition, it calls upon the Commission to produce a report on the scale of the problem, along with an assessment of whether amendments to Union legislation on medicinal products or other relevant Union legislation are required. The present call for tender is intended to provide the Commission with an assessment of the risks of medicinal products to the environment and to human health via the environment, an analysis of the relevance of the current legislative framework to, and its effectiveness at, protecting the environment and human health via the environment, and finally an identification of possible measures to better address the problem, which may serve as the basis for the Commission report.

This call for tender has been closed. The deadline to submit offers was the 10 October 2011.

  • Questions and Answers (last update : 07-10-2011)
  • Contract award notice


  • Contract Notice
  • Invitation to tenderers
  • Tender specifications
  • Annex Ia: Tender submission form
  • Annex Ib: Letter of mandate
  • Annex IIa: Legal entity form for public entities
  • Annex IIb: Legal entity form for private entities
  • Annex IIc: Legal entity form for individuals
  • Annex III: Financial identification form - the "Privacy statement"
  • Annex IV: Declaration of honour
  • Annex V: Financial offer
  • Annex VI: Draft contract and annexes
  • Annex VII: Economic and financial capacity overview
  • Annex VIII: Checklist

For more information please contact:

NB: The original versions of the above documents are prepared in English. All the other language versions are only translations of the original English version that are made available for the information of the tenderers.