Yes, HBELs should be established for all products. HBELs for highly hazardous products are expected to be completed in full as per the EMA guideline (EMA/CHMP/CVMP/SWP/169430/2012) or equivalent.
Yes, HBELs should be established for all products. HBELs for highly hazardous products are expected to be completed in full as per the EMA guideline (EMA/CHMP/CVMP/SWP/169430/2012) or equivalent.