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中华人民共和国药品管理法(一)

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中华人民共和国药品管理法
PHARMACEUTICAL ADMINISTRATION LAW OF THE PEOPLE'S REPUBLIC OF CHINA

(Adopted at the Seventh Meeting of the Standing Committee of the Sixth National People's Congress, promulgated by Order No. 18 of the President of the People's Republic of China on September 20, 1984, and effective as of July 1, 1985)
时效性:已被修正  颁布日期:19840920  实施日期:19850701  失效日期:20011201  颁布单位:全国人大常委会

  Contents

  Chapter I General Provisions

  Chapter II Administration of Pharmaceutical Producing Enterprises

  Chapter III Administration of Pharmaceutical Trading Enterprises

  Chapter IV Administration of Pharmaceuticals at Medical Units

  Chapter V Pharmaceutical Administration

  Chapter VI Packaging and Repackaging of Pharmaceuticals

  Chapter VII Pharmaceuticals Under Special Control

  Chapter VIII Administration of Trademarks and Advertisements of Pharmaceuticals

  Chapter IX Supervision over Pharmaceuticals

  Chapter X Legal Responsibility

  Chapter XI Supplementary Provisions

  Chapter I General Provisions

  Article 1 This Law is formulated with a view to enhancing the supervision and control of pharmaceuticals, ensuring their quality, improving their curative effects, guaranteeing safety in medication and safeguarding the health of the people.

  Article 2 The administrative department of health under the State Council shall be responsible for the supervision and control of pharmaceuticals throughout the country.

  Article 3 The state shall develop both modern and traditional medicines and give full play to their role in the prevention and treatment of diseases and in health care. The state shall protect the resources of wild medicinal materials and encourage the domestic cultivation of Chinese traditional medicinal crops.

  Chapter II Administration of Pharmaceutical Producing Enterprises

  Article 4 The establishment of a pharmaceutical producing enterprise must be sanctioned by the competent authorities for the production and trading of pharmaceuticals of the province, autonomous region, or municipality directly under the Central Government in which the enterprise is located, and approved by the administrative department of health of the same province, autonomous region or municipality, which will issue a Pharmaceuticals Producer Licence. The administrative authorities for industry and commerce shall not issue business licences to any enterprises producing pharmaceuticals without the Pharmaceutical Producer Licence. The Pharmaceutical Producer Licence shall have a period of validity, upon expiration of which a new licence shall be issued after an examination for its renewal. Detailed measures for the renewal of such licences shall be stipulated by the administrative department of health under the State Council.

  Article 5 To establish a pharmaceutical producing enterprise, the following requirements must be met:

  (1) It shall be staffed with the necessary personnel required for producing the medicines concerned, that is, pharmacists or technical personnel with a qualification equivalent to or higher than assistant engineer as well as skilled workers. If an enterprise processing Chinese traditional medicines into ready-to-use mixture and powder forms does not have pharmacists or technical personnel with a qualification equivalent to or higher than assistant engineer, it shall be staffed instead with skilled pharmaceutical workers who are familiar with the properties of the medicines processed and are registered with the administrative department of health at or above the county level.

  (2) It shall have factory premises, facilities and a sanitary environment suitable for the medicines produced.

  (3) It shall have a unit or competent personnel capable of inspecting the quality of the medicines produced, as well as necessary instruments and equipment.

  Article 6 Pharmaceuticals must be produced in accordance with the technological procedure, and the record of production must be complete and accurate. The process for preparing traditional Chinese medicines in ready-to-use forms must conform to the Pharmacopoeia of the People's Republic of China or the Processing Norms stipulated by the administrative departments of health of the provinces, autonomous regions, or municipalities directly under the Central Government.

  Article 7 The raw and supplementary materials used for the production of pharmaceuticals and containers and packaging materials in direct contact with pharmaceuticals must conform to the requirements for medicinal use.

  Article 8 Pharmaceuticals must go through quality inspection before they leave the factory; products which do not meet the standards shall not leave the factory.

  Article 9 Pharmaceutical producing enterprises must draw up and carry out rules and regulations and sanitary requirements for ensuring the quality of pharmaceuticals in accordance with the Standards for Quality Control of Pharmaceutical Production stipulated by the administrative department of health under the State Council.

  Chapter III Administration of Pharmaceutical Trading Enterprises

  Article 10 The establishment of a pharmaceutical trading enterprise must be sanctioned by the local competent authorities for the production and trading of pharmaceuticals and approved by the administrative department of health at or above the county level, which will issue a Pharmaceutical Trading Enterprise Licence. The administrative authorities for industry and commerce shall not issue business licences to any enterprises without the Pharmaceutical Trading Enterprise Licence.

  The Pharmaceutical Trading Enterprise Licence shall have a period of validity, upon expiration of which a new licence shall be issued after an examination for its renewal. Detailed measures for the renewal of such licences shall be stipulated by the administrative department of health under the State Council.

  Article 11 To establish a pharmaceutical trading enterprise, the following requirements must be met:

  (1) It shall be staffed with pharmaceutical technicians qualified for the handling of the pharmaceuticals.

  If an enterprise trading in Chinese traditional medicines or an enterprise concurrently trading in medicines does not have pharmaceutical technicians, it shall be staffed instead with pharmaceutical workers who are familiar with the properties of the medicines it trades in and are registered with the administrative department of health at or above the county level.

  (2) It shall have business premises, equipment, storage facilities and a sanitary environment suitable for the pharmaceuticals in which it trades.

  Article 12 The quality of pharmaceuticals must be inspected on purchasing. Pharmaceuticals that do not meet the required standards must not be purchased.

  Article 13 It is imperative, in the sale of pharmaceuticals, to be accurate and free of mistakes, and to provide correct directions for use, dosage and precautions. Prescriptions being dispensed must be checked.

  Pharmaceuticals listed in prescriptions must not be presumptuously changed or substituted. Prescriptions containing incompatible substances or excessive dosages shall be rejected by the dispensary. If necessary, such prescriptions can be dispensed after they have been corrected or resigned by the doctors who wrote them out.

  When famous traditional Chinese medicinal materials are offered for sale, their origin must be indicated.

  Article 14 Rules for storage of pharmaceuticals shall be formulated and implemented by pharmaceutical warehouses, which must adopt necessary measures to facilitate cold storage and protection against moisture, insects and rodents.

  An inspection system shall be carried out for pharmaceuticals entering or leaving warehouses.

  Article 15 Unless otherwise stipulated by the state, traditional Chinese medicinal materials may be marketed at urban or rural fairs.

  Pharmaceuticals other than traditional Chinese medicinal materials may not be sold at urban or rural fairs, except by those who have Pharmaceuticals Trading Enterprise Licences.

  Chapter IV Administration of Pharmaceuticals at Medical Units

  Article 16 Medical units must be staffed with pharmaceutical technical personnel commensurate with their medical functions. Non-pharmaceutical technical personnel may not engage directly in pharmaceutical technical work.

  Article 17 To make medicinal preparations, a medical unit must be examined, approved and issued a Dispensing Permit by the administrative department of health of the province, autonomous region, or municipality directly under the Central Government in which the units is located.

  The Dispensing Permit shall have a period of validity, upon expiration of which a new permit shall be issued after an examination for its renewal.

  Detailed measures for the renewal of such permits shall be stipulated by the administrative department of health under the State Council.

  Article 18 Medical units making medicinal preparations must be equipped with facilities, inspection instruments and sanitary conditions capable of ensuring the quality of the preparations.

  Article 19 The quality of the medicinal preparations made by medical units must be inspected in accordance with relevant regulations and clinical needs.

  Those up to standard can be used as the doctor prescribes.

  Medicinal preparations made by medical units may not be sold on the market.

  Article 20 Medical units must implement a system of quality inspection when purchasing pharmaceuticals.

  Chapter V Pharmaceutical Administration

  Article 21 The state encourages research on and development of new medicines.

  When working on a new medicine, it is necessary to submit, as required, the methods of production, quality indices, pharmacological and toxicological testing results, and other related materials and samples to the administrative department of health under the State Council or to the administrative department of health of the relevant province, autonomous region, or municipality directly under the Central Government. Clinical tests or clinical verifications can be carried out only after approval.

  A new medicine which has completed its clinical tests or clinical verifications and been approved after appraisal shall be issued a certificate by the administrative department of health under the State Council.

  Article 22 A new medicine can be put into production only after the administrative department of health under the State Council has approved it and issued a registered document of approval. However, this does not apply to the production of traditional Chinese medicines prepared in ready-to-use forms.

  A medicine standardized by the state or by a province, an autonomous region, or a municipality directly under the Central Government shall be put into production only after the administrative department of health of the relevant province, autonomous region, or municipality directly under the Central Government has made an examination of the medicine, given it approval and issued a registered document of approval, seeking beforehand the opinions of the authorities at the same level in charge of the production and trading of medicines. However, this does not apply to the production of traditional Chinese medicines prepared in ready-to-use forms.

  Article 23 Pharmaceuticals must meet the pharmaceutical standards of the state or those of the relevant province, autonomous region, or municipality directly under the Central Government.

  The Pharmacopoeia of the People's Republic of China and the pharmaceutical standards promulgated by the administrative department of health under the State Council shall be the state pharmaceutical standards.

  The Pharmacopoeia Committee of the administrative department of health under the State Council shall be responsible for organizing the formulation and revision of the state pharmaceutical standards.

  Article 24 The administrative department of health under the State Council and administrative departments of health of provinces, autonomous regions, and municipalities directly under the Central Government may establish pharmaceutical examination and evaluation committees to carry out examination and evaluation of new medicines and to reevaluate medicines already put into production.

  Article 25 The administrative department of health under the State Council shall organize investigations of medicines which have been approved for production. It shall revoke the registered documents of approval if it discovers that the medicines' curative effects are uncertain or poor, or that they produce serious adverse reactions or for other reasons are harmful to people's health.

  Production and sale of medicines whose registered documents of approval have been revoked shall not be allowed to continue; those which have already been produced shall be destroyed or disposed of under the supervision of the local administrative department of health.

  Article 26 Import of medicines whose curative effects are uncertain or poor, or which produce adverse reactions or have other harmful effects on people's health shall be prohibited.

  Article 27 For any medicine which is to be imported for the first time, the importer must submit the manuals, quality standards, methods of inspection and other related information and samples, as well as the exporting country's (region's) certification documents approving its production, to the administrative department of health under the State Council, and import contracts may be signed only with the prior approval of the said department.

  Article 28 Imported medicines must be inspected by the pharmaceutical inspection institutions authorized by the administrative department of public health under the State Council; those having passed the inspection shall be allowed to be imported. Medicines to be imported in small quantities for urgent clinical needs by medical units or for personal use shall be handled according to customs regulations.

  Article 29 The administrative department of health under the State Council shall have the power to restrict or prohibit the export of traditional Chinese medicinal materials and prepared Chinese medicines which are in short supply in the domestic market.

  Article 30 Import Licences or Export Licences issued by the administrative department of health under the State Council are required for the import or export of narcotics and psychotropic substances falling within the restricted scope prescribed by the administrative department of health under the State Council.

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