Recommendation on harmonising the approach to causality assessment for adverse events to veterinary medicinal products (revision 1)
|Current effective version||Adopted recommendation|
|Reference number||EMA/CVMP/PhVWP/552/2003 – Rev.1|
|Keywords||Causality assessment, lack of expected efficacy (LEE)|
This recommendation provides further guidance on how to carry out causality assessment, based on the principles laid out in Volume 9B of The Rules Governing Medicinal Products in the European Union (EU) – Guidelines on Pharmacovigilance for Medicinal Products for Veterinary Use and includes additional guidance on causality assessment of adverse events classified as off-label and lack of expected efficacy (LEE) concerning pharmaceuticals.
|Adopted guideline||In operation: 15/10/2004 – 01/01/2014|