欧盟《传统植物药指令》(简称《指令》)从5月1日起全面实施,这意味着“高门槛”之下未通过注册的中药将不得在欧盟市场上作为药品销售和使用。2004年4月30日生效的欧盟《指令》要求,包括中药在内的传统植物药必须向成员国主管部门申请注册,经审批同意后才能在欧盟市场上继续作 The EU’s “Traditional Botanical Medicines Directive” (the “Directive”) is fully implemented from May 1, which means that Chinese medicines not registered under the “high threshold” will not be marketed and used as drugs in the EU market. The EU Directive, which came into force on April 30, 2004, requires that traditional botanical drugs, including traditional Chinese medicines, must be applied for registration to the competent authorities of member states and can only continue to be approved on the EU market