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231901-2021 - Belgium-Brussels: Production, Priority-purchasing Options and Supply of Covid-19 Vaccines, Including Adapted Vaccines to SARS-CoV-2 Variants and Paediatric Formulations of such Vaccines for EU Member States
Belgium-Brussels: Feasibility Study of an Active-substance-based Review System (‘Monographs’) and Other Potential Alternatives for the Environmental Risk Assessment of Veterinary Medicinal Products
Notice for changes or additional information
(Supplement to the Official Journal of the European Union, 2020/S 072-170143)
Section I: Contracting authority/entity
Section II: Object
Feasibility Study of an Active-substance-based Review System (‘Monographs’) and Other Potential Alternatives for the Environmental Risk Assessment of Veterinary Medicinal Products
The study aims to identify, collect and analyse evidence to assess the feasibility of the active substance based approach and of possible alternatives, against the reference of the current product-based approach for ERA in the Veterinary Medicinal Products. Quantitative and qualitative data to assess the feasibility of the options and identify the expected impacts shall be provided and analysed in line with the quality standards and the principles established in the European Commission's better regulation guidelines and toolbox. The study will be based on the VMP Regulation and will focus on the main pillars of that legislation.
Section VI: Complementary information
Section VII: Changes