9On the community code relating to medicinal products for human use[EB/OL].http//eurlex.europa.eu/LexUriServ/LexUriServ.do?uri -OJ:L:2001:311:0067:0128:EN:PDF.
10Presentation on the new Japanese Pharmaceutical Affairs Law Overview[EB/OL].http://203.208.39.132/search?q =cache:NaOBKmgo -ywJ:www,omnex.com/training/iso 13485/japan/Japan_regulatory_reqs-Jan_05.pdf+Presentation + on + the + new + Japanese + Pharmaceutical + Affairs + Law +Overview&cd=2&hl=zh-C N&ct=clnk&gl=cn&st_usg=ALhdy2_CgR0t7u OOja2szzPwqDZn99n4Hg.
