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中药品种保护条例
Regulations on Protection of Traditional Chinese Medicines
第一条为了提高中药品种的质量，保护中药生产企业的合法权益，促进中药事业的发展，制定本条例。
Article 1 This decree is hereby formulated with the aims of raising the quality of all varieties of traditional Chinese medicines, of protecting the legal rights and interests of enterprises engaged in the production of traditional Chinese medicines, and of promoting the development of activities relating to traditional Chinese medicines.
第二条本条例适用于中国境内生产制造的中药品种，包括中成药、天然药物的提取物及其制剂和中药人工制成品。
Article 2 This Decree is applicable for all varieties of traditional Chinese medicines produced and/or prepared within the territory of China, including the traditional Chinese proprietary medicines, the extract and preparation of medicinal herbs, and the processed traditional Chinese herbs.
申请专利的中药品种，依照专利法的规定办理，不适用本条例。
This Decree is not applicable for those varieties of traditional Chinese medicines applying for patent rights, which is subject to the law governing patent rights.
第三条国家鼓励研制开发临床有效的中药品种，对质量稳定、疗效确切的中药品种实行分级保护制度。
Article 3 The State practises graded protection for those varieties of traditional Chinese medicines stable in its quality and effective in its therapeutic results in order to encourage the research and development of new varieties of traditional Chinese medicines with clinical effectiveness.
第四条国务院卫生行政部门负责全国中药品种保护的监督管理工作。国家中药生产经营主管部门协同管理全国中药品种的保护工作。
Article 4 Health administrative departments under the State Council are responsible for the supervision and administration of activities relating to the protection of traditional Chinese medicines. The responsible departments at the state level in charge of the preparation and management of traditional Chinese medicines are to assist in the management of activities for the protection of all varieties of traditional Chinese medicines.
第二章中药保护品种等级的划分和审批
CHAPTER II THE GRADING AND APPROVAL OF PROTECTION OF VARIETIES OF TRADITIONAL CHINESE MEDICINES
第五条依照本条例受保护的中药品种，必须是列入国家药品标准的品种。经国务院卫生行政部门认定，列为省、自治区、直辖市药品标准的品种，也可以申请保护。
Article 5 All varieties of traditional Chinese medicines covered by this Decree for protection shall be those listed as the standardized medicines at the state level. Application can be raised for those varieties listed, with the approval of health administrative departments under the State Council, as standardized medicines at the provincial/municipal/autonomous regional level.
受保护的中药品种分为一、二级。
All varieties covered by this Decree are divided into Grade 1 and Grade 2 in its protection.
第六条符合下列条件之一的中药品种，可以申请一级保护：
Article 6 All varieties of traditional Chinese medicines conforming with 1 of the following requirements can apply for Grade 1 protection: that
（一）对特定疾病有特殊疗效的；
(1) are with special therapeutic results to a given disease;
（二）相当于国家一级保护野生药材物种的人工制成品；
(2) are prepared with natural medicinal herbs covered by Grade 1 protection by the state; and
（三）用于预防和治疗特殊疾病的。
(3) are applicable to the prevention and treatment of certain specific diseases.
第七条符合下列条件之一的中药品种，可以申请二级保护：
Article 7 All varieties of traditional Chinese medicines conforming with 1 of the following requirements can apply for Grade 2 protection:
（一）符合本条例第六条规定的品种或者已经解除一级保护的品种；
(1) are conforming with the stipulations set forth in Article 6, and are removed from Grade 1 protection;
{0>（二）对特定疾病有显著疗效的；
(2) are with noticeable therapeutic results to a given disease; and
（三）从天然药物中提取的有效物质及特殊制剂。
(3) are extracted, and/or specifically prepared with its effective ingredient from natural medicinal herbs.
第八条国务院卫生行政部门批准的新药，按照国务院卫生行政部门规定的保护期给予保护；其中，符合本条例第六条、第七条规定的，在国务院卫生行政部门批准的保护期限届满前六个月，可以重新依照本条例的规定申请保护。
Article 8 Any new variety of traditional Chinese medicines having been duly approved by health administrative departments under the State Council are subject to protection for a period as specified by the health administrative departments under the State Council, of which, if having been found conforming with the stipulations as set forth in Article 6 and/or Article 7, can apply, following the procedures as set forth in this Decree, for protection 6 months prior to the termination of the period for protection as approved specifically by health administrative departments under the State Council.
第九条申请办理中药品种保护的程序：
Article 9 Procedures of application for protection of the variety of traditional Chinese medicines:
（一）中药生产企业对其生产的符合本条例第五条、第六条、第七条、第八条规定的中药品种，可以向所在地省、自治区、直辖市中药生产经营主管部门提出申请，经中药生产经营主管部门签署意见后转送同级卫生行政部门，由省、自治区、直辖市卫生行政部门初审签署意见后，报国务院卫生行政部门。
(1) Enterprises engaged in the preparation of traditional Chinese medicines can apply for protection of their products that conform with the stipulations as set forth in Article 5, Article 6, Article 7 and Article 8. The application shall be submitted to the responsible departments of local province/municipality/autonomous region in charge of the preparation and management of traditional Chinese medicines for written verification, and to be further verified by local health administrative departments at the same level before its submission to the health administrative departments under the State Council.
特殊情况下，中药生产企业也可以直接向国家中药生产经营主管部门提出申请，由国家中药生产经营主管部门签署意见后转送国务院卫生行政部门，或者直接向国务院卫生行政部门提出申请。
Under specific conditions, enterprises engaged in the preparation of traditional Chinese medicines may submit its application directly to the health administrative departments under the State Council, or, submit its application through the responsible departments at the state level in charge of the preparation and managements of traditional Chinese medicines for written verification.
（二）国务院卫生行政部门委托国家中药品种保护审评委员会负责对申请保护的中药品种进行审评。国家中药品种保护审评委员会应当自接到申请报告书之日起六个月内做出审评结论。
(2) Health administrative departments under the State Council entrusts the National Committee on the Assessment of the Protected Traditional Chinese Medicinal Products P. R. C. for assessment which is to be completed with a conclusion within 6 months as of the date of its receipt of the application.
（三）根据国家中药品种保护审评委员会的审评结论，由国务院卫生行政部门征求国家中药生产经营主管部门的意见后决定是否给予保护。批准保护的中药品种，由国务院卫生行政部门发给《中药保护品种证书》。
(3) Taking into account of the conclusion reached by the National Committee on the Assessment of the Protected Traditional Chinese Medicinal Products P.R.C. the health administrative departments under the State Council is to make a decision, after consulting with the responsible departments at the state level in charge of the preparation and management of traditional Chinese medicines, on whether a protection is to be granted. The health administrative departments under the State Council is to issue "the Certificate of Variety of Traditional Chinese Medicine under Protection" to those granted with a protection.
国务院卫生行政部门负责组织国家中药品种保护审评委员会，委员会成员由国务院卫生行政部门与国家中药生产经营主管部门协商后，聘请中医药方面的医疗、科研、检验及经营、管理专家担任。
The health administrative departments under the State Council are responsible for the formulation of the National Committee on the Assessment of the Protected Traditional Chinese Medicinal Products P. R. C. by inviting, after consulting with the responsible departments at the state level in charge of the preparation and management of traditional Chinese medicines, experts of traditional Chinese medicines in areas of clinical activities, scientific research, laboratory experiments, administration and management to serve as members on the Committee.
第十条申请中药品种保护的企业，应当按照国务院卫生行政部门的规定，向国家中药品种保护审评委员会提交完整的资料。
Article 10 The applying enterprises shall submit adequate information material, as specified by the health administrative departments under the State Council, to the National Committee on the Assessment of the Protected Traditional Chinese Medicinal Products P.R.C..
第十一条对批准保护的中药品种以及保护期满的中药品种，由国务院卫生行政部门在指定的专业报刊上予以公告。
Article 11 The health administrative departments under the State Council are to publish, on designated specialized papers, the varieties of traditional Chinese medicines granted with a protection, and that whose protection period is terminated.
第三章中药保护品种的保护
CHAPTER III PROTECTION OF THE PROTECTED VARIETIES OF TRADITIONAL CHINESE MEDICINES
第十二条中药保护品种的保护期限：
Article 12 The protection period lasts respectively for:
中药一级保护品种分别为三十年、二
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