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Commentary on the draft revised guideline on the environmental risk assessment of medicinal products for human use

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  • Rhys Whomsley, European Medicines Agency
  • ,
  • Susanne Brendler-Schwaab, Federal Institute for Drugs and Medical Devices (BfArM)
  • ,
  • Eadaoin Griffin, Health Products Regulatory Authority
  • ,
  • John Jensen
  • Caroline Moermond, National Institute for Public Health and the Environment (RIVM)
  • ,
  • Birger Scholz, Swedish Medical Products Agency
  • ,
  • Laila Sortvik Nilssen, The Norwegian Medicines Agency (NOMA)
  • ,
  • Henry Stemplewski, Medicines & Healthcare Products Regulatory Agency (MHRA)
  • ,
  • Ines Roennefahrt, German Environment Agency

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 released for public consultation a draft revision of the guideline. The revision proposes significant substantive and structural changes to the guideline. The major changes proposed in the revision are outlined together with the rationale for the changes and the expected impact on stakeholders.

Original languageEnglish
Article number17
JournalEnvironmental Sciences Europe
Number of pages4
Publication statusPublished - 2019

    Research areas

  • CHMP, EMA, Environmental risk assessment, ERA, European Medicines Agency, Human pharmaceuticals, PBT

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