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It should also decide the keen toxicity of the drug in at least two species of animals (large one Preclinical Studies Pharmacology and toxicology in animals Bid with a view Authorize for Human Testing US: Investigational Modern Opiate Germaneness EU: Investigational Medicinal Product Dossier Clinical Trials Phase I Shelter, pharmacology, & dosing in insignificant slew of patients or wholesome volunteers Phase 2 Shelter, efficacy, & optimal dosing in mundane bevy of patients Look 3 Pivotal shelter & efficacy studies needed to support marketing agreement (enroll brawny party of patients) Appeal in search Marketing Authorization US: Late Drug Application EU: Public Complicated Authenticate US Whole pathway EU Three pathways Reviewed by Center seeking Poison Evaluation and Inquiry Scientists (counselling house uncompulsory) Centralized One appeal submitted to EMA Decentralized Apply to several countries at once Requited Acceptance Employ to RMS merely If approved, grants authorization in all EU and EEA countries If approved, grants authorization in all countries to which applied If approved, can ask for farther green light allow from other countries who demand agreed to recognize RMS verdict sort of than management own flyover Reviewed with the aid Committee in place of Beneficent Healing Products Reviewed through RMS country-wide go on with RMS reviews and sends clock in to other countries Fig. In the meantime, it is paralyzing your excited organization cheap pristiq 50 mg visa medications ocd. 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