Cover of Scientific Opinion Paper
Chemicals

Monographs of Environmental Data for Active Substances in Veterinary Pharmaceuticals

The essential base for assessing and managing risks


This scientific opinion paper outlines existing problems related to data gaps, non-harmonized assessments, insufficient post-market control, and data transparency of pharmaceuticals, and identifies possible solutions through the introduction of a monograph system for active pharmaceutical substances. From UBA's point of view, monographs are the crucial bridge between risk assessment, risk communication and risk management and this across different regulatory areas. The current revision of the general pharmaceutical legislation of the EU offers the opportunity to establish a monograph system for active substances for both veterinary medicinal products and medicinal products for human use.

Series
Scientific Opinion Paper
Number of pages
22
Year of publication
Author(s)
Ines Rönnefahrt, Susanne Schmitz, Ina Ebert
Language
English
Publisher
Umweltbundesamt
File size
1675 KB
Price
0,00 €
Print version
not available
rated as helpful
57
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Tags:
 pharmaceutical  environmental risk assessment