commiss regul ec march lai arrang report suspect unexpect advers reaction aris commun countri medicin product human veterinari author accord provis council regul eec commiss european commun regard treati establish european commun regard council regul eec juli lai commun procedur author supervis medicin product human veterinari establish european agenc evalu medicin product articl paragraph paragraph thereof number advers reaction summari product characterist medicin product occur identifi time market medicin product articl provid report suspect advers reaction medicin product human veterinari medicin product innov medicin product deserv close pharmacovigil supervis interest human anim health includ unexpect suspect advers reaction aris commun countri report holder market author health profession veterinari sector person holder market author appli variat market author confirm suspect unexpect advers reaction classifi due medicin product question european agenc evalu medicin product hereinaft refer agenc respons coordin activ member state field monitor advers reaction medicin product pharmacovigil measur provid regul accord opinion stand committe human veterinari medicin product adopt regul articl person respons place medicin product market ensur suspect unexpect advers reaction medicin product author accord provis regul eec classifi aris commun countri report compet author member state agenc articl requir laid condit grant market author commun suspect unexpect advers reaction report holder market author distinct identifi section period report refer articl regul eec safeti updat safeti updat consist line list individu case report accompani scientif evalu includ narr review natur relev characterist reaction special attent chang frequenc articl data incorpor relev safeti updat end period refer articl regul eec data lock point safeti updat submit compet author dai data lock point articl unexpect suspect advers reaction assess carri holder market author attribut medicin product requir chang summari product characterist refer articl paragraph council direct eec amend direct eec articl paragraph council direct eec amend direct eec dealt accord commiss regul ec march amend direct eec examin variat term market author fall scope council regul eec commiss regul eec march examin variat term market author grant compet author member state articl regul enter forc dai public offici journal european commun regul bind entireti directli applic member state brussel march commiss martin bangemann member commiss oj oj oj oj oj page offici journal page offici journal