in accordance with the regulations, belabeled and include directions for use.The label or directions must indicate the name of the medicine,specifications, the producer, registration number, batch number of theproduct, principal components, indications, directions for use dosage,contraindications, adverse reactions and precautions.Special indications must be printed as required on the labels ofnarcotics, psychotropic substances, toxic drugs, radioactive drugs andmedicines for external use.Article 38A pharmaceuticals trading enterprise engaged in the repackaging ofmedicines must possess the necessary facilities and sanitary conditionssuitable for the purpose, and pharmaceutical technicians must be placed incharge of this work. The repackaging records must be complete andaccurate.The repackaged medicine must enclose directions for use, and on thepackage must be indicated the name of the medicine, specifications, theproducer, the batch number of the product, the repackaging unit and thelot number of the repackaged product. If the medicine has a period ofvalidity, it must also be indicated on the new package.
【章名】Chapter VII Pharmaceuticals Under Special Control
Article 39The state adopts special measures for the control of narcotics,psychotropic substances, toxic drugs and radioactive drugs. Regulationsfor the control of these drugs shall be formulated by the State Council.Article 40Narcotics, including their mother plants, must be produced only by unitsjointly designated by the administrative department of health under theState Council and other departments concerned, and must be supplied byunits jointly designated by the administrative department of health ofprovinces, autonomous regions, and municipalities directly under theCentral Government and other departments concerned.
【章名】Chapter VIII Administration of Trademarks and Advertisements of Pharmaceuticals
Article 41Registered trademarks must be used for all pharmaceuticals with theexception of traditional Chinese medicinal materials and theirpreparations in ready-to-use forms. The sale of pharmaceuticals withoutcompleting trademark registration shall be prohibited.The registered trademark must appear on the package and the label of themedicine.Article 42Advertisements of pharmaceuticals must be examined and approved by theadministrative department of health of the relevant province, autonomousregion, or municipality directly under the Central Government. In theabsence of such approval, advertisement of any medicine may not bepublished, broadcast, handed out or posted on walls.Article 43Foreign enterprises which apply to advertise pharmaceuticals in China mustsubmit relevant documents of approval by the country (region) in which thepharmaceuticals are produced, directions for use and other relevantmaterials.Article 44Advertisements of pharmaceuticals must be based on the directions for useapproved by the administrative department of health under the StateCouncil or the administrative departments of health of provinces,autonomous regions, or municipalities directly under the CentralGovernment.
【章名】Chapter IX Supervision over Pharmaceuticals
Article 45The administrative departments of health at or above the county levelshall exercise supervisory power over pharmaceuticals.The administrative departments of health at or above the county level mayset up organs for the administration of pharmaceuticals and organs for theinspection of pharmaceuticals.Article 46There shall be pharmaceutical inspectors in the administrative departmentsof health at or above the county level. Pharmaceutical inspectors shall beappointed from among pharmacological technical personnel and issuedcertificates by the people's governments at the same level.Article 47Pharmaceutical inspectors are authorized to exercise, in accordance withthe regulations, supervision, inspection and sampling as regards thequality of pharmaceuticals in the producing enterprises, tradingenterprises and medical units within their jurisdiction, and whennecessary may pick samples at random and ask for relevant data inaccordance with regulations. The enterprises and units concerned may notrefuse such requests or withhold relevant data. Pharmaceutical inspectorsare duty-bound to keep confidential the technical information provided bypharmaceutical producing enterprises and scientific research institutions.Article 48Pharmaceutical producing enterprises, pharmaceutical trading enterprisesand medical institutions shall conduct regular surveys of the quality,curative effects and adverse reactions of the pharmaceuticals they haveproduced, traded in or used. When drug poisoning is discovered, themedical institution concerned must promptly report the matter to the localadministrative department of health.Article 49The organs or personnel in charge of pharmaceutical inspection inpharmaceutical producing enterprises and pharmaceutical tradingenterprises shall receive operational guidance from the localpharmaceutical inspection organs.
【章名】Chapter X Legal Responsibility
Article 50Whoever produces or sells fake medicines shall have his fake medicines andunlawful income confiscated and may concurrently be fined; in addition, hemay be ordered to suspend production or business operations pendingrectification, or have his Pharmaceutical Producer Licence, PharmaceuticalTrading Enterprise Licence or Dispensing Permit revoked.An individual who produces or sells fake medicines, or the person directlyresponsible for a unit which commits this offence, and thereby endangerspeople's health, shall be investigated for criminal liability underArticle 164 of the Criminal Law.Article 51Whoever produces or sells medicines of inferior quality shall have hismedicines of inferior quality and unlawful income confiscated and may befined as well. If the circumstances are serious, the unit concerned shallbe ordered to suspend production or business operations pendingrectification, or have its Pharmaceutical Producer Licence, PharmaceuticalTrading Enterprise Licence or Dispensing Permit revoked. An individualwho produces or sells medicines of inferior quality or the person directlyresponsible for a unit which commits this offence, and thereby endangerspeople's health and causes serious consequences, shall be investigated forcriminal liability in reference to the provisions of Article 164 of theCriminal Law.Article 52Any unit engaged in the production, trading or preparation of medicineswithout obtaining the Pharmaceutical Producer Licence, PharmaceuticalTrading Enterprise Licence or Dispensing Permit shall be ordered tosuspend production, business operations or preparation of such medicines.The medicines and unlawful income shall all be confiscated and a fine mayalso be imposed.Article 53Whoever violates any other provision of this Law on the administration ofpharmaceutical production and pharmaceutical trading shall be served awarning or be fined.
Article 54The decision to mete out administrative sanctions stipulated in this Lawshall be made by the administrative departments of health at or above thecounty level. The decision to mete out administrative sanctions forviolations of the provisions of Article 15 or of Chapter VIII onadministration of advertisements of this Law shall be made by theadministrative departments for industry and commerce.Punishment by suspension of production or business operations pendingrectification for seven days or more, or revocation of the PharmaceuticalProducer Licence or Pharmaceutical Trading Enterprise Licence to be metedout to pharmaceutical producing enterprises or pharmaceutical tradingenterprises directly under the jurisdiction of the Central Government orof the people's governments of provinces, autonomous regions, ormunicipalities directly under the Central Government, shall be submittedby the administrative department of health of the relevant province,autonomous region, or municipality directly under the C