EN PL

EMA: Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

27.11.2014
This document aims to recommend an approach for deriving a scientifically based threshold value for individual active substances to be applied for risk identification. The guideline outlines how the data on which the threshold value is derived should be presented in order to achieve a clear and harmonious approach across pharmaceutical industry.