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  Article 31 Newly discovered domestic medicinal plants or medicinal plants introduced from abroad may be sold only after they have been examined and approved by the administrative department of health of the relevant province, autonomous region, or municipality directly under the Central Government.

  Article 32 Measures for controlling medicinal materials traditionally used by local people in certain regions shall be formulated 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 components are different from those prescribed for it by state pharmaceutical 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 registration number;

  (3) where the medicine has deteriorated 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 contagious diseases or any other disease which may contaminate the medicines shall not be allowed to engage in any work which has direct contact with pharmaceuticals.

  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 consignor, 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, specifications, the producer, registration number, batch number of the product, principal components, indications, directions for use dosage, contraindications, adverse reactions and precautions.

  Special indications must be printed as required on the labels of narcotics, psychotropic substances, toxic 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 sanitary 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 pack

age 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 jointly 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 Trademarks 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 trademark 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 Supervision 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 inspection of pharmaceuticals.

  Article 46 There shall be pharmaceutical inspectors 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 authorized 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 jurisdiction, and when necessary may pick samples at random and ask for relevant data in accordance with regulations. The enterprises and units concerned may not refuse such requests or withhold relevant data. Pharmaceutical inspectors are duty-bound to keep confidential 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 discover

ed, the medical institution concerned must promptly 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 confiscated and may concurrently be fined; in addition, he may be ordered to suspend production or business operations pending rectification, or have his Pharmaceutical Producer Licence, Pharmaceutical Trading Enterprise Licence or Dispensing Permit revoked.

  An individual who produces or sells fake medicines, or the person directly responsible for a unit which commits this offence, and thereby 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 A


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