Lisaks Ravimiametile peab kliinilise uuringu sponsor uuritava ja võrdlusravimiga Eestis ilmnenud tõsistest ettearvamatutest kõrvalnähtudest teatama kirjalikult ka uuringule kooskõlastuse andnud eetikakomiteele «Ravimiseaduse» § 90 lõike 8 alusel kehtestatud korras sätestatud tähtaegadel ja vormis.
In addition to the Agency of Medicines, the sponsor of the clinical trial shall also notify in writing the ethics committee who granted consent to the trial of serious unexpected adverse events occurring with the investigational medicinal product and the reference medicinal product in Estonia within the established terms and in the established form pursuant to the procedure established on the basis of subsection 90 (8) of the Medicinal Products Act.
Information on each ‘bulk product’ before trial-specific operations (blinding, trial specific packaging and labelling) should be provided in this section for each investigational medicinal product (IMP) being tested including each comparator and each placebo, if applicable.
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