CAJ | 학술논문

英国对未注册植物药的管理发生了重大变化。欧盟《传统植物药注册程序指令》(2004/24/EC)颁布后，英国对原药品法修订为“注册人员允许销售未注册植物药”，而从业人员注册的管理法规尚未颁布；同时，允许未注册植物药在销售过渡期继续流通。但随着未注册植物药的安全性频频出现问题，英国药品和健康产品管理局经过对社会各界的咨询，最终决定将销售过渡期截至2014年4月30日。因此，英国的中医从业人员在此日期后无法销售，也无权销售未注册的中药，这对中医药在英国的发展带来巨大障碍。
영국대미주책식물약적관리발생료중대변화。구맹《전통식물약주책정서지령》(2004/24/EC)반포후，영국대원약품법수정위“주책인원윤허소수미주책식물약”，이종업인원주책적관리법규상미반포；동시，윤허미주책식물약재소수과도기계속류통。단수착미주책식물약적안전성빈빈출현문제，영국약품화건강산품관리국경과대사회각계적자순，최종결정장소수과도기절지2014년4월30일。인차，영국적중의종업인원재차일기후무법소수，야무권소수미주책적중약，저대중의약재영국적발전대래거대장애。
The regulations of unregistered herbal medicine had important changes in the UK after the EU Directive 2004/24/EC promulgation. British Drugs Act was amended to allow the sale of unregistered herbal medicine by registered practitioners, however, the regulations about the register of parishioners has not been issued yet. At the same time, the unregistered herbal medicine can be sold during the transitional period. But as problems about unregistered herbal medicine security appeared frequently, MHRA decided that the deadline for transitional period was April 30, 2014 through the consulting from all sectors of society. Therefore, the TCM practitioners in the UK cannot sell, and even have no right to sell unregistered herbal medicine after this date, which will bring a huge obstacle on the TCM development in the UK.