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.
![Cover of Scientific Opinion Paper](https://www.umweltbundesamt.de/sites/default/files/styles/600w850h/public/medien/1410/bilder/cover_2023-04-20_scientific_opinion_paper_uba_monographs_on_environmental_data_of_active_pharmaceutical_substances_0.png?itok=AVHoBDy4)
Chemicals
Monographs of Environmental Data for Active Substances in Veterinary Pharmaceuticals
The essential base for assessing and managing risks
Reihe
Scientific Opinion Paper
Seitenzahl
22
Erscheinungsjahr
Autor(en)
Ines Rönnefahrt, Susanne Schmitz, Ina Ebert
Sprache
Englisch
Verlag
Umweltbundesamt
Dateigröße
1675 KB
Preis
0,00 €
Druckversion
nicht lieferbar
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79