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


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2019-12

AUTHORS

Rhys Whomsley, Susanne Brendler-Schwaab, Eadaoin Griffin, John Jensen, Caroline Moermond, Birger Scholz, Laila Sortvik Nilssen, Henry Stemplewski, Ines Roennefahrt

ABSTRACT

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. More... »

PAGES

17

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/s12302-019-0198-9

DOI

http://dx.doi.org/10.1186/s12302-019-0198-9

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1112689651


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