commiss regul ec octob amend annex regul ec avoid trade divers european union kei medicin commiss european commun regard treati establish european commun regard council regul ec avoid trade divers european union kei medicin articl thereof commiss receiv applic articl regul ec respect pharmaceut product commiss determin applic receiv fulfil requir set regul ec accord procedur laid articl regul applic inform commiss decis accept applic add product concern annex regul ec adopt regul articl product detail mention annex regul ad annex regul ec avoid trade divers european union kei medicin articl regul enter forc dai public offici journal european union bind entireti directli applic member state brussel octob commiss pascal lami member commiss oj annex