{0>第十九条对临床用药紧缺的中药保护品种，根据国家中药生产经营主管部门提出的仿制建议，经国务院卫生行政部门批准，由仿制企业所在地的省、自治区、直辖市卫生行政部门对生产同一中药保护品种的企业发放批准文号。<}0{>Article 19 Upon the proposal raised by the responsible departments at the state level in charge of the preparation and management of traditional Chinese medicines, and with the approval of health administrative departments under the State Council, relating to the replication preparation of the protected varieties of traditional Chinese medicines much in need of clinically, the health departments of the province/municipality/autonomous region, in which, the replicating enterprise is situated, may grant approval for replication preparation of the said protected variety. <0}

{0>该企业应当付给持有《中药保护品种证书》并转让该中药品种的处方组成、工艺制法的企业合理的使用费，其数额由双方商定；双方不能达成协议的，由国务院卫生行政部门裁决。 <}0{>The enterprise shall make a reasonable amount of payment to the enterprise granted with "the Certificate of Variety of Traditional Chinese Medicines under Protection" for the transference of information of the ingredients and formulae, and technical know-how. The amount of payment is to be decided upon by both sides through consultation, or, to be decided upon by the health administrative departments under the State Council if no agreement is reached through consultation.<0}

{0>第二十条生产中药保护品种的企业及中药生产经营主管部门，应当根据省、自治区、直辖市卫生行政部门提出的要求，改进生产条件，提高品种质量。 <}0{>Article 20 Enterprises engaged in the preparation of the protected varieties of traditional Chinese medicines and responsible departments at the local level in charge of the preparation and management of traditional Chinese medicines shall, following the requirements raised by the health administrative departments at the provincial/ municipal/ autonomous regional level, constantly improve its working conditions and raise the quality of its products.<0}

{0>第二十一条中药保护品种在保护期内向国外申请注册的，须经国务院卫生行政部门批准。 <}0{>Article 21 Application for registration in areas outside the country of any protected variety of traditional Chinese medicines within the protection period is subject to the approval of the health administrative departments under the State Council.<0}

{0>第二十二条违反本条例第十三条的规定，造成泄密的责任人员，由其所在单位或者上级机关给予行政处分；构成犯罪的，依法追究刑事责任。 <}0{>Article 22 Any person responsible for the leakage of a secret as a result of violating the stipulation of Article 13 of this Decree is to be given with a disciplinary sanction by the department the said person is affiliated, or, by administrative bodies at a higher level; and is to be affixed the person's criminal responsibility according to law if the cases constitutes a crime.<0}

{0>第二十三条违反本条例第十七条的规定，擅自仿制中药保护品种的，由县级以上卫生行政部门以生产假药依法论处。 <}0{>Article 23 Any violence of the stipulation of Article 17 of this Decree by replicating presumptuously the preparation of any protected variety of traditional Chinese medicines is to be regarded as the preparation of counterfeit medicine and to be dealt with according to law by the health administrative departments at county level and above.<0}

{0>伪造《中药品种保护证书》及有关证明文件进行生产、销售的，由县级以上卫生行政部门没收其全部有关药品及违法所得，并可以处以有关药品正品价格三倍以下罚款。 <}0{>The health administrative departments at the county level and above are to confiscate all products and illegal income of any preparation and sale of traditional Chinese medicines with a counterfeit "the Certificate of Variety of Traditional Chinese Medicines under Protection", and to impose a fine to any amount no more than 3 folds of the price of the variety legally prepared.<0}

{0>上述行为构成犯罪的，由司法机关依法追究刑事责任。 <}0{>Judicial departments are to affix its criminal responsibility according to law if any activities as listed above constitute a crime.<0}

{0>第二十四条当事人对卫生行政部门的处罚决定不服的，可以依照有关法律、行政法规的规定，申请行政复议或者提起行政诉讼。 <}0{>Article 24 If any party refuses the ruling of the health administrative departments may apply for administrative reconsideration, or, lodge an administrative appeal following the stipulations concerned in law and administrative regulations.<0}

{0>第二十五条有关中药保护品种的申报要求、申报表格等，由国务院卫生行政部门制定。 <}0{>Article 25 The requirements and forms for application for protection of varieties of traditional Chinese medicines are to be formulated by the health administrative departments under the State Council.<0}

{0>第二十六条本条例由国务院卫生行政部门负责解释。 <}0{>Article 26 The rights for the interpretation of this Decree rest on the health administrative departments under the State Council.<0}

{0>第二十七条本条例自一九九三年一月一日起施行。<}0{>Article 27 The Decree comes into effect as of January 1,1993.<0}

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