摘要
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。
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.
出处
《中国中医药信息杂志》
CAS
CSCD
2014年第12期5-7,共3页
Chinese Journal of Information on Traditional Chinese Medicine
基金
国家中医药管理局中医药政策研究项目(Y00301)
中国中医科学院基本科研业务费自主选题项目(ZZ040808
ZZ050807)
关键词
植物药
注册
英国
法规
herbal medicine
register
United Kingdom
regulation
