Journal
ENVIRONMENTAL SCIENCES EUROPE
Volume 31, Issue -, Pages -Publisher
SPRINGEROPEN
DOI: 10.1186/s12302-019-0198-9
Keywords
Environmental risk assessment; European Medicines Agency; Human pharmaceuticals; ERA; EMA; CHMP; PBT
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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 12years' 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.
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