decis eea joint committe june amend annex ii technic regul standard test certif eea agreement eea joint committe regard agreement european econom area amend protocol adjust agreement european econom area hereinaft refer quot agreement quot articl thereof annex ii agreement amend decis joint committe eea januari commiss direct ec june amend chapter va pharmacovigil council direct eec approxim provis laid law regul administr action relat medicin product incorpor agreement commiss regul ec april lai provis implement criteria design medic product orphan medicin product definit concept quot similar medicin product quot quot clinic superior quot incorpor agreement decid articl indent ad point council direct eec chapter xiii annex ii agreement quot commiss direct ec june oj quot articl point insert point regul ec european parliament council chapter xiii annex ii agreement quot commiss regul ec april lai provis implement criteria design medic product orphan medicin product definit concept similar medicin product clinic superior oj quot articl text direct ec regul ec iceland norwegian languag publish eea supplement offici journal european commun authent articl decis enter forc june provid notif articl agreement made eea joint committe articl decis publish eea section eea supplement offici journal european commun brussel june eea joint committe presid westerlund oj oj oj constitut requir