Environmental risk assessment for veterinary medicinal products. Part 2. The phase 1 assessment for immunological products. Report on the workshop 23-9-1998
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Authors
Montforts MHMMType
OnderzoeksrapportLanguage
en
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Environmental risk assessment for veterinary medicinal products. Part 2. The phase 1 assessment for immunological products. Report on the workshop 23-9-1998Translated Title
Milieubeoordeling voor diergeneesmiddelen. Deel 2. De fase 1 benadering voor immunologische producten. Verslag van de workshop 23-9-1998Publiekssamenvatting
In het rapport wordt een voorstel gedaan voor een vereenvoudigde Fase 1 benadering voor immunologische diergeneesmiddelen. Dit schema is ontworpen omdat bleek dat de bestaande guidance van de EMEA te ingewikkeld en te arbeidsintensief was om efficient tot beslissingen over de aanvaardbaarheid van middelen met een laag risico te komen.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.
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