In the case of investigational medicinal products, the manufacturer shall, in cooperation with the sponsor, implement a system for recording and reviewing complaints together with an effective system for recalling promptly and at any time investigational medicinal products which have already entered the distribution network.
V primeru zdravil v preskušanju izdelovalec v sodelovanju s sponzorjem izvaja sistem evidentiranja in pregledovanja pritožb skupaj z učinkovitim sistemom takojšnjega in stalnega odpoklica zdravil v preskušanju, ki so že vstopila v distribucijsko mrežo.