1773 Two-step release procedure: by It is difficult enough to get a single the QP and by the sponsor. release (by the QP) organised in the available timeframe, let introducing a second release. This is not practicable. 1817 Instances of administration of an Each time or is it sufficient to report out-of specification product to a these instances on a yearly basis? clinical subject should be notified to the relevant competent authorities.
1773 Two-step release procedure: by the QP and by the sponsor. It is difficult enough to get a single release (by the QP) organised in the available timeframe, let introducing a second release. This is not practicable. 1817 Instances of administration of an out-of specification product to a clinical subject should be notified to the relevant competent authorities. Each time or is it sufficient to report these instances on a yearly basis?
uza_ccrg.docx