The document provides updated guidance on the preclinical and clinical aspects of the application procedure for those who seek approval of such products. The guideline replaces the "Efficacy of veterinary medicinal products for use in farmed aquatic species" and takes into account the development during recent years, and feedback obtained from users of the previous guideline which was last revised in 1994.
The deadline for submitting comments is 30 April 2010. Comments should be submitted to vet-guidelines@emea.europa.eu.
Further Reading
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