Toxicity marketing authorisations

Toxicity studies are expected to be performed in compliance with Good Laboratory Practice (GLP) however, it is recognised that some studies employing specialised test systems which are often needed for biopharmaceuticals, may not be able to comply fully with GLP. Areas of non-compUance should be identified and their significance evaluated relative to the overall safety assessment. In some cases, lack of full GLP compliance does not necessarily mean that the data from these studies cannot be used to support clinical trials and marketing authorisations. 

If a biocidal product is classified as toxic, very toxic, carcinogenic, mutagenic or toxic for reproduction (category 1 or 2) it shall not be authorised for marketing to, or use by the general public. 

---