This guideline applies to all human and veterinary medicinal products, including investigational medicinal products, and all active substances that are intended for manufacture in premises used for the manufacture of other products or active substances. The scope of the present guideline is to ensure the safety of human patients and target animals exposed to residual active substances via medicinal products as well as consumers potentially exposed to residual active substances in products derived from treated food producing animals.
|Download document||Draft guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities|
|Status||draft: consultation open|
|Consultation start date||08/01/2013|
|Consultation end date||30/06/2013|
|Email address for submissions||SWP-H@ema.europa.eu|