中华人民共和国药品管理法（二）

ny unit engaged in the production， trading or preparation of medicines without obtaining the Pharmaceutical Producer Licence， Pharmaceutical Trading Enterprise Licence or Dispensing Permit shall be ordered to suspend production， business operations or preparation of such medicines.

　　The medicines and unlawful income shall all be confiscated and a fine may also be imposed.

　　Article 53 Whoever violates any other provision of this Law on the administration of pharmaceutical production and pharmaceutical trading shall be served a warning or be fined.

　　Article 54 The decision to mete out administrative sanctions stipulated in this Law shall be made by the administrative departments of health at or above the county level. The decision to mete out administrative sanctions for violations of the provisions of Article 15 or of Chapter VIII on administration of advertisements of this Law shall be made by the administrative departments for industry and commerce.

　　Punishment by suspension of production or business operations pending rectification for seven days or more， or revocation of the Pharmaceutical Producer Licence or Pharmaceutical Trading Enterprise Licence to be meted out to pharmaceutical producing enterprises or pharmaceutical trading enterprises directly under the jurisdiction of the Central Government or of the people's governments of provinces， autonomous regions， or municipalities directly under the Central Government， shall be submitted by the administrative department of health of the relevant province， autonomous region， or municipality directly under the Central Government to the people's government at the same level for final decision.

　　Punishment by suspension of production or business operations for seven days or more， or revocation of the Pharmaceutical Producer Licence or Pharmaceutical Trading Enterprise Licence， to be meted out to pharmaceutical producing enterprises or pharmaceutical trading enterprises under the jurisdiction of people's governments at or below the city or county level， shall be submitted by the administrative department of health of the people's governments

at or below the city or county level to the people's governments at the same level for final decision. The confiscated pharmaceuticals shall be disposed of under the supervision of the administrative departments of health.

　　Article 55 If the party concerned does not accept the administrative sanction decided on， it may file suit in the people's court within 15 days after receiving notification of the sanction. However， the said party must immediately carry out the decision on the control of pharmaceuticals made by the administrative department of health. If the party neither complies with the sanction nor files suit within the time limit， the organ which made the decision on the administrative sanction shall apply to the people's court for compulsory execution.

　　Article 56 If any individual or unit， in violation of this Law， causes drug poisoning， he or it shall be liable for the damage. The victims may request the administrative department of health at or above the county level to handle the matter； if a party does not accept the decision， it may file suit in the people's court. The victims， too， may directly take the case to the people's court.

　　The claim for compensation must be made within a year from the day on which the victim or his representative was aware or should have been aware of the damage done. No claim for compensation shall be entertained beyond the time limit.

　　Chapter XI Supplementary Provisions

　　Article 57 For the purpose of this Law， the definitions of the following terms are：

　　“Pharmaceuticals” means articles intended for use in the prevention， treatment or diagnosis of human diseases， or intended to effect the purposive regulation of human physiological functions， for which indications， usage and dosage are prescribed， including raw traditional Chinese medicinal materials， traditional medicines prepared in ready-to- use forms and other prepared Chinese medicines， medicinal chemicals and their preparations， antibiotics， biochemical medicines， radioactive drugs， serums， vaccines， blood products， diagnostic aids， etc.

　　“New medicines” means medicines which have not been produced in this country before. “Supplementary materials” means the excipients and additives used for the production and dispensing of pharmaceuticals.

　　“Pharmaceutical producing enterprise” means an enterprise exclusively or partly engaged in the production of pharmaceuticals.

　　“Pharmaceutical trading enterprise” means an enterprise exclusively or partly engaged in the trading of pharmaceuticals.

　　Article 58 The production of pharmaceuticals referred to in this Law does not include the cultivation， collection and breeding of all categories of medicinal materials used in traditional Chinese medicine.

　　Article 59 The administrative department of health under the State Council shall， pursuant to this Law， draw up measures for its implementation， which shall enter into force after being submitted to and approved by the State Council.

　　Measures for the control of pharmaceuticals specially needed by the Chinese People's Army shall be formulated by the competent military department of the state.

　　Article 60 This Law shall enter into force as of July 1， 1985

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