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The ERA ESEC operates under the Environmental Risk Assessment Working Party (ERAWP) and Non-clinical Working Party (NCWP), and is overseen by the Committee for Medicinal Products for Human Use (CHMP) and Committee for Veterinary Medicinal Products (CVMP).
The ERA ESEC provides a platform for:
The specialised expert community does not contribute to any regulatory procedures or actions related to product-related scientific evaluations or scientific guidelines. It does not give advice or take decisions. Individual members may contribute to EMA’s scientific work as members of scientific committees, working parties or drafting groups.
The specialised expert community's mandate is available below:
The ERA ESEC is composed of European experts with a special interest or expertise in the area of environmental risk assessment. They are selected from within the European medicines regulatory network and academia (e.g. research institutions or universities).
Members are nominated by a committee member/alternate. Membership is endorsed by CHMP and CVMP.
All members have signed a public declaration of interests and confidentiality undertaking form.