Normally, maximum residue limits (MRLs) based on toxicological or microbiological effects are used to ensure consumer safety in respect of foodstuffs derived from animals treated with veterinary medicinal products. Some substances, however, can exert pharmacological effects on humans at levels below those producing toxicological/microbiological effects. In such cases, the Committee for Medicinal Products for Veterinary Use (CVMP) recommends an acceptable daily intake (ADI) approach based on a pharmacological no-observed-adverse-effect level (NOAEL). Its recent guidance outlines when to establish a pharmacological ADI, and the endpoints that could be considered when investigating the pharmacodynamic actions of the substance.


European Medicines Agency. Committee for Medicinal Products for Veterinary Use (CVMP). Guideline on the approach to establish a pharmacological ADI. EMA/CVMP/SWP/355689/2006.


The above item was taken from the December 2012 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).

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