Law of China

Pharmaceutical Administration Law of China-1984

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

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 bc 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 count 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, 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 re-signed 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 re-evaluate 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.

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 relevant 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, specification, 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 pharmaceutical 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 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 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 discovered, 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 he 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 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 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 administrativc 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 Xl Supplementary Provisions

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

“Pharmaceutical” 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-for-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 Liberation 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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