Example: biology
Medicinal Exposure
Found 2 free book(s)
Standard operating procedure - Europa
www.ema.europa.eu2001/83/EC in respect of the medicinal product concerned. In the case of medicinal products imported from third countries, the supervisory authority(ies) shall be the competent authority(ies) of the Member State(s) that granted the manufacturing authorisation provided for in Article 40(3)
Guideline on assessment and control of DNA reactive ...
www.ema.europa.euTTC-based acceptable intake of 0.025 µg/kg bw/day other than less -than-lifetime exposure, may apply, including: treatment of a life -threatening condition, limited therapeutic alternatives, or where the impurity is a known substance and exposure will be much greater from other sources (e.g. food or endogenous metabolism).