EMA: Draft reflection paper on injection-site residues: considerations for risk assessment and residue surveillance (revision 1)

Residues in injection-site muscle for some products tend to be dramatically higher than residues in non-injection-site muscle (as well as in fat, liver and kidney). The result is that a single carcass may contain muscles with very different residue levels of injectable substances, and these differing levels of residues in a single tissue type make setting an appropriate maximum residue limit (MRL) very challenging. The Committee for Medicinal Products for Veterinary Use (CVMP) has developed an approach that could be used consistently to develop appropriate MRLs for injectable substances. This reflection paper describes that approach.