definiens: means II human cl;nicaltrial of a Licensed Product on a s.ufrl(:ient number of subjIXIS thai ; 5 desi~ to e.slabli!;h that a pharmaceutical product is ! ; afe lIIld effiucious for its intended use . and 10 dcnnc wamings, precautions . and adverse reactions that are associated with such phllllllK"Culica l product in the dosage ran~ 10 be prescribed, and to 5Uppan Approva l of such pharmaceu tical product or label elIpllruiion of such pha.nnace utical PfOduCL 1.85 means I pro < luci support human dinical trial of a licensed Product ( i.e .. II clinical trial ", ttlth is not required for re«ipt of ApproYolI for a country but which may be useful in providing additional drug profile dala ) ! hat is IIpprovcd by the JOC alld made part orlhe Development Plln aOO 11111 is < il commenced before ra : eipl of Approval in the country for wilich suc;h trial is conducted or ( ii ) is required or requested by a Regulatory Authority liS a condition of or in connection with an Approval j(whclher commenced prior 10 or afler receipt of Approval ) l