Environmental risk assessment for veterinary medicinal products. Part 2. The phase 1 assessment for immunological products. Report on the workshop 23-9-1998
Milieubeoordeling voor diergeneesmiddelen. Deel 2. De fase 1 benadering voor immunologische producten. Verslag van de workshop 23-9-1998
26 May 2012, PDF |
50 pages |
RIVM Report 601300002
This report contains a proposal for a simplified Phase 1 assessment for immunological veterinary medicinal products. This scheme was constructed as it was felt that the existing guidance as given by the EMEA was too complex and laborous to reach quick decisions on the acceptability of low-risk products.