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- Nilssen, Laila Sortvik, et al. Show all 9 Authors
- Environmental sciences Europe 2019 v.31 no.1 pp. 17
- European Union; environmental assessment; guidelines; humans; marketing; risk assessment; stakeholders
- ... Applicants for marketing authorisation for human medicinal products in the European Union must submit an environmental risk assessment which is assessed by assessors from the national competent authorities. The EMA guideline on the environmental risk assessment of medicinal products for human use came into effect on 1 December 2006. After 12 years’ experience with the guideline, the EMA has releas ...