中华人民共和国药品管理法（二）

　　Article 32 Measures for controlling medicinal materials traditionally used by local people in certain regions shall be formulated³ by the administrative department of health under the State Council.

　　Article 33 The production and sale of fake medicines are prohibited. A fake medicine has either of the following characteristics：

　　（1） the names of its components⁴ are different from those prescribed for it by state pharmaceutical⁵ standards or pharmaceutical standards of the relvant province， autonomous region， or municipality directly under the Central Government；

　　（2） a non-medical substance is passed off as a medicine， or one medicine is passed off as another.

　　A medicine shall be handled as fake medicine in any of the following cases：

　　（1） where the use of the medicine has been prohibited by the administrative department of health under the State Council；

　　（2） where the medicine has been produced without being assigned a registration⁶ number；

　　（3） where the medicine has deteriorated⁷ and cannot be used as such； or

　　（4） where the medicine has been contaminated and cannot be used as such.

　　Article 34 The production and sale of medicines of inferior quality shall be prohibited. A medicine of inferior quality has any of the following characteristics：

　　（1） the components of the medicine do not conform in quantity to that required by state pharmaceutical standards or pharmaceutical standards of the relevant province， autonomous region， or municipality directly under the Central Government；

　　（2） the medicine has passed its expiry date； or

　　（3） the medicine fails to meet the prescribed standards in other respects.

　　Article 35 Personnel in pharmaceutical producing or trading enterprises and in medical units who have direct contact with medicines must undergo an annual medical examination. Persons who have contracted contagious⁸ diseases or any other disease which may contaminate the medicines shall not be allowed to engage in any work which has direct contact with pharmaceuticals⁹.

　　Chapter VI Packaging and Repackaging of Pharmaceuticals

　　Article 36 Packaging must meet the specific quality requirements of the pharmaceuticals and facilitate their storage， transportation and medical use. If a medicine has a period of validity， it must be clearly indicated on the package.

　　Traditional Chinese medicinal materials must be packaged before transportation. There must appear on the package the name of the medicine， place of production， date， name of the consignor¹⁰， and an indication that the quality of the medicine is up to standard.

　　Article 37 Packages of pharmaceuticals must， in accordance with the regulations， be labeled and include directions for use.

　　The label or directions must indicate the name of the medicine， specifications¹¹， the producer， registration number， batch¹² number of the product， principal components， indications， directions for use dosage， contraindications， adverse¹³ reactions and precautions.

　　Special indications must be printed as required on the labels of narcotics¹⁴， psychotropic substances， toxic¹⁵ drugs， radioactive drugs and medicines for external use.

　　Article 38 A pharmaceuticals trading enterprise engaged in the repackaging of medicines must possess the necessary facilities and sanitary¹⁶ conditions suitable for the purpose， and pharmaceutical technicians must be placed in charge of this work. The repackaging records must be complete and accurate.

　　The repackaged medicine must enclose directions for use， and on the package must be indicated the name of the medicine， specifications， the producer， the batch number of the product， the repackaging unit and the lot number of the repackaged product. If the medicine has a period of validity， it must also be indicated on the new package.

　　Chapter VII Pharmaceuticals Under Special Control

　　Article 39 The state adopts special measures for the control of narcotics， psychotropic substances， toxic drugs and radioactive drugs. Regulations for the control of these drugs shall be formulated by the State Council.

　　Article 40 Narcotics， including their mother plants， must be produced only by units jointly¹⁷ designated by the administrative department of health under the State Council and other departments concerned， and must be supplied by units jointly designated by the administrative department of health of provinces， autonomous regions， and municipalities directly under the Central Government and other departments concerned.

　　Chapter VIII Administration of Trademarks¹⁹ and Advertisements of Pharmaceuticals

　　Article 41 Registered trademarks must be used for all pharmaceuticals with the exception of traditional Chinese medicinal materials and their preparations in ready-to-use forms. The sale of pharmaceuticals without completing trademark¹⁸ registration shall be prohibited.

　　The registered trademark must appear on the package and the label of the medicine.

　　Article 42 Advertisements of pharmaceuticals must be examined and approved by the administrative department of health of the relevant province， autonomous region， or municipality directly under the Central Government. In the absence of such approval， advertisement of any medicine may not be published， broadcast， handed out or posted on walls.

　　Article 43 Foreign enterprises which apply to advertise pharmaceuticals in China must submit relevant documents of approval by the country （region） in which the pharmaceuticals are produced， directions for use and other relevant materials.

　　Article 44 Advertisements of pharmaceuticals must be based on the directions for use approved by the administrative department of health under the State Council or the administrative departments of health of provinces， autonomous regions， or municipalities directly under the Central Government.

　　Chapter IX Supervision²⁰ over Pharmaceuticals

　　Article 45 The administrative departments of health at or above the county level shall exercise supervisory power over pharmaceuticals.

　　The administrative departments of health at or above the county level may set up organs for the administration of pharmaceuticals and organs for the inspection²¹ of pharmaceuticals.

　　Article 46 There shall be pharmaceutical inspectors²² in the administrative departments of health at or above the county level. Pharmaceutical inspectors shall be appointed from among pharmacological technical personnel and issued certificates by the people's governments at the same level.

　　Article 47 Pharmaceutical inspectors are authorized²³ to exercise， in accordance with the regulations， supervision， inspection and sampling as regards the quality of pharmaceuticals in the producing enterprises， trading enterprises and medical units within their jurisdiction²⁴， and when necessary may pick samples at random²⁵ and ask for relevant data in accordance with regulations. The enterprises and units concerned may not refuse such requests or withhold²⁶ relevant data. Pharmaceutical inspectors are duty-bound to keep confidential²⁷ the technical information provided by pharmaceutical producing enterprises and scientific research institutions.

　　Article 48 Pharmaceutical producing enterprises， pharmaceutical trading enterprises and medical institutions shall conduct regular surveys of the quality， curative effects and adverse reactions of the pharmaceuticals they have produced， traded in or used. When drug poisoning is discovered， the medical institution concerned must promptly²⁸ report the matter to the local administrative department of health.

　　Article 49 The organs or personnel in charge of pharmaceutical inspection in pharmaceutical producing enterprises and pharmaceutical

　　trading enterprises shall receive operational guidance from the local pharmaceutical inspection organs.

　　Chapter X Legal Responsibility

　　Article 50 Whoever produces or sells fake medicines shall have his fake medicines and unlawful income confiscated²⁹ and may concurrently³⁰ be fined； in addition， he may be ordered to suspend production or business operations pending³¹ rectification³²， or have his Pharmaceutical Producer Licence， Pharmaceutical Trading Enterprise Licence or Dispensing³³ Permit revoked³⁴.

　　An individual who produces or sells fake medicines， or the person directly responsible for a unit which commits this offence， and thereby³⁵ endangers people's health， shall be investigated for criminal liability under Article 164 of the Criminal Law.

　　Article 51 Whoever produces or sells medicines of inferior quality shall have his medicines of inferior quality and unlawful income confiscated and may be fined as well. If the circumstances are serious， the unit concerned shall be ordered to suspend production or business operations pending rectification， or have its Pharmaceutical Producer Licence， Pharmaceutical Trading Enterprise Licence or Dispensing Permit revoked. An individual who produces or sells medicines of inferior quality or the person directly responsible for a unit which commits this offence， and thereby endangers people's health and causes serious consequences， shall be investigated for criminal liability in reference to the provisions of Article 164 of the Criminal Law.

　　Article 52 Any 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 mete³⁶ out administrative sanctions stipulated³⁷ 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 violations³⁹ 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 revocation⁴⁰ of the Pharmaceutical Producer Licence or Pharmaceutical Trading Enterprise Licence to be meted⁴¹ 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 decided⁴² 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 compulsory⁴³ execution.

　　Article 56 If any individual or unit， in violation³⁸ 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 Supplementary⁴⁴ 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 diagnosis⁴⁵ of human diseases， or intended to effect the purposive regulation of human physiological⁴⁶ 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， antibiotics⁴⁷， biochemical medicines， radioactive drugs， serums⁴⁸， vaccines⁴⁹， blood products， diagnostic aids， etc.

　　“New medicines” means medicines which have not been produced in this country before. “Supplementary materials” means the excipients and additives⁵⁰ 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 cultivation⁵¹， 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 implementation⁵²， which shall enter into force after being submitted to and approved by the State Council.

　　Measures for the control of pharmaceuticals specially⁵³ 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.