| Food Hygiene Law of the People’s Republic of China |
(Adopted at the 16th Meeting of the Standing Committee of the Eighth
National People's Congress on October 30, 1995, promulgated by Order No.
59 of the President of the People's Republic of China on October 30,
1995, and effective as of the date of promulgation)
Chapter I
General Provisions
Article 1 This Law is enacted for the purpose of ensuring food
hygiene, preventing food contamination and harmful substances from
injuring human health, safeguarding the health of the people and
improving their physical fitness. Article 2 The State institutes a system of food hygiene supervision. Article 3 The administrative department of public health under the State Council shall be in charge of supervision and control of food hygiene throughout the country. Other relevant departments under the State Council shall, within the scope of their respective functions and duties, be responsible for control of food hygiene. Article 4 Whoever engages in food production or marketing within the territory of the People's Republic of China must observe this Law. This Law applies to all foods and food additives as well as containers, packagings , utensils and equipment used for food, detergents and disinfectants; it also applies to the premises, facilities and environment associated with food production or marketing. Article 5 The State encourages and protects the social supervision exercised by public organizations and individuals over food hygiene. Any person shall have the right to inform the authorities and lodge a complaint about any violation of this Law.
Chapter II
Food Hygiene
Article 6 Food shall be nontoxic and harmless, conform to proper
nutritive requirements and have appropriate sensory properties such as
colour, fragrance and taste. Article 7 Principal and supplementary foods intended specially for infants and preschool children shall conform to the nutritive and hygienic standards promulgated by the administrative department of public health under the State Council. Article 8 In the process of food production or marketing, the requirements for hygiene stated below shall be conformed t (1) The environment inside and outside any food production or marketing establishment shall be kept clean and tidy; measures shall be taken to eliminate flies, rodents, cockroaches and other harmful insects and to remove conditions for their propagation; and a prescribed distance shall be kept from any toxic or harmful site; (2) An enterprise engaged in food production or marketing shall have workshops or other premises for the preparation of raw materials and for processing, packing and storage that are commensurate with the varieties and quantities of the products handled; (3) Appropriate facilities shall be made available for disinfectants, changing clothes, toilet, natural and artificial light, ventilation, prevention of spoilage, protection against dust, elimination of flies and rodents, washing of equipment, sewage discharge and the containment of garbage and other wastes; (4) The layout of installations and the application of technological processes shall be rational in order to prevent contamination between foods to be processed and ready-to-eat foods, and between raw materials and finished products; food must not be placed in contact with any toxic substance or filth; (5) Tableware, kitchenware and containers for ready-to-eat foods must be cleaned and disinfected prior to use; cooking utensils and other utensils must be washed after use and kept clean; (6) Any containers, packagings, utensils and equipment used for the storage, transportation, loading and unloading of food as well as the conditions under which these operations are carried out must be safe, harmless and kept clean in order to prevent food contamination; (7) Ready-to-eat foods shall be kept in small packets or in nontoxic, clean packaging materials; (8) All persons involved in food production or marketing shall maintain a constant standard of personal hygiene, taking care to wash their hands thoroughly and wear clean work clothes and headgear while preparing or selling food; also, proper utensils must be used when selling ready-to-eat foods; (9) Any water used must conform to the national hygiene standards for drinking-water in urban and rural areas; (10) The detergents and disinfectants used shall be safe and harmless to human health. The hygienic requirements for food production or marketing undertaken by food vendors and persons engaged in the food business in urban and rural markets shall be formulated specifically according to this Law by the standing committees of the people's congresses in the provinces, autonomous regions, or municipalities directly under the Central Government. Article 9 The production and marketing of foods in the following categories shall be prohibited: (1) foods that can be injurious to human health because they are putrid or deteriorated, spoiled by rancid oil or fat, moldy, infested with insects or worms, contaminated, contain foreign matter or manifest other abnormalities in sensory properties; (2) foods that contain or are contaminated by toxic or deleterious substances and can thus be injurious to human health; (3) foods that contain pathogenic parasites, microorganisms or an amount of microbial toxin exceeding the tolerance prescribed by the State; (4) meat and meat products that have not been inspected by the veterinary health service or have failed to pass such inspection; (5) poultry, livestock, game and aquatic animals that have died from disease, poisoning or some unknown cause, as well as products made from them; (6) foods contaminated by use of filthy or seriously damaged containers or packages, or filthy means of conveyance; (7) foods that impair nutrition or health because they are adulterated or misbranded; (8) foods processed with non-food raw materials; foods mixed with non-food chemical substances, or non-food stuffs used as food; (9) foods that has expired the date for guaranteed quality; (10) foods of which the sale has been specifically prohibited, for the prevention of diseases or other special reasons, by the administrative department of public health under the State Council or by the people's governments of the provinces, autonomous regions, or municipalities directly under the Central Government; (11) foods that contain additives not approved for use by the administrative department of public health under the State Council or residues of pesticides exceeding the tolerance prescribed by the State; (12) other foods that do not conform to the standards and requirements for food hygiene. Article 10 Food must not contain medicinal substances, with the exception of those materials that have traditionally served as both food and medicaments and are used as raw materials, condiments or nutrition fortifiers.
Chapter III
Hygiene of Food Additives
Article 11 The production, marketing and use of food additives must
conform to the hygiene standards for use of food additives and the
hygiene control regulations; the food additives that do not conform to
the hygiene standards and the hygiene control regulations may not be
marketed and used.
Chapter IV
Hygiene of Containers, Packagings, Utensils and Equipment Used for Food
Article 12 Containers, packagings, utensils and equipment used for food must conform to the hygiene standards and the hygiene control regulations. Article 13 The raw materials for making containers, packagings, utensils and equipment used for food must meet hygiene requirements. The finished products should be easy to clean and disinfect.
Chapter V
Formulation of Food Hygiene Standards and Regulations for Food Hygiene Control
Article 14 The administrative department of public health under the
State Council shall formulate or approve and promulgate the national
hygiene standards, hygiene control regulations and inspection procedures
for food, food additives, the containers, packagings, utensils and
equipment used for food, the detergents and disinfectants used for
washing food or utensils and equipment used for food, and the tolerances
for contaminants and radioactive substances in food. Article 15 If the State has not formulated hygiene standards for a certain food, the people's governments of the provinces, autonomous regions, or municipalities directly under the Central Government may establish local hygiene standards for that food and report them to the administrative department of public health under the State Council and the competent standardization administration department under the State Council for the record. Article 16 Norms of significance to the science of health to be included in the national quality standards for food additives must be examined and approved by the administrative department of public health under the State Council. Appraisals on the safety for use of agricultural chemicals, such as pesticides and chemical fertilizers, shall be examined and approved by the administrative department of public health under the State Council. Veterinary hygiene inspection procedures for slaughtered livestock and poultry shall be formulated jointly by the relevant administrative departments under the State Council and the administrative department of public health under the State Council.
Chapter VI
Food Hygiene Control
Article 17 The departments in charge of control of food production
or marketing of the people's governments at various levels shall
strengthen control of food hygiene and oversee the implementation of
this Law. The people's governments at various levels shall encourage and support efforts to improve food processing technology so as to promote the improvement of hygienic quality of food. Article 18 Enterprises engaged in food production or marketing shall improve their own system for food hygiene control, appoint full-time or part-time workers to control food hygiene and strengthen inspection of the foods they produce or market. Article 19 The selection of sites and the designs for construction, extension or renovation projects of enterprises engaged in food production or marketing shall meet hygiene requirements, and the administrative department of public health must participate in the examination of those designs and in the inspection and acceptance of finished projects. Article 20 Before starting production of new varieties of food or food additives with new resources, the enterprises engaged in their production or marketing must submit the data required for evaluation of the hygiene and nutrition of such products; before starting production of new varieties of containers, packagings, utensils or equipment used for foods, with new raw or processed materials, the enterprises engaged in their production or marketing must submit the data required for evaluation of the hygiene of such products. Before the new varieties mentioned above are put into production, it shall also be necessary to provide samples of the varieties and the matter shall be reported for examination and approval in accordance with the specified procedures for examining and approving food hygiene standards. Article 21 Any standardized packaged food or food additive must, according to the requirements for different products, have the name of the product, the place of manufacture, the name of the factory, the date of manufacture, the batch number (or code number), the specifications, the formula or principal ingredients, the date of expiration for guaranteed quality, the method of consumption or use, and other such information indicated in the label of the package or the product description. The product description for any food or food additive shall not contain exaggerated or false advertising. The label of the food package must be clearly printed and easy to read. Foods sold on domestic markets must have labels in the Chinese language. Article 22 With regard to the food indicated to have specific health functions, the products and its description must be submitted to the administrative department of public health under the State Council for examination and approval; its hygiene standards and the measures for control of its production and marketing shall be formulated by the administrative department of public health under the State Council. Article 23 The food indicated to have specific health functions may not be harmful for human health; the content of the product description shall be true, and the functions and ingredients of the product shall be identical with the information given in the product description and there shall be no false information. Article 24 Food, food additives and containers, packagings and other utensils used specially for food may be dispatched from factory or sold only after their producers have carried out inspection and found them to be up to the standards according to the hygiene standards and the hygiene control regulations. Article 25 Whenever producers or marketers of food procure supplies, they shall, in accordance with the relevant State regulations, request inspection certificates or laboratory test reports and the supplier must provide these. The scopes and types of food that requires certificates shall be specified by the administrative department of public health of the people's governments of the provinces, autonomous regions, or municipalities directly under the Central Government. Article 26 All persons engaged in food production or marketing must undergo an annual medical examination; persons newly employed or serving temporarily in this field must also undergo a medical examination and may not start work until they have obtained health certificates. No persons suffering from dysentery, typhoid, viral hepatitis or other infectious diseases of the digestive tract (including pathogen carriers), active tuberculosis, suppurative or exudative dermatosis or any other disease incompatible with food hygiene, may be engaged in any work involving contact with ready-to-eat foods. Article 27 Enterprises engaged in food production or marketing as well as food vendors must obtain a hygiene licence issued by the administrative department of public health before they shall be permitted to apply for registration with the administrative departments of industry and commerce. No person who has not obtained a hygiene licence may engage in food production or marketing. Food producers or marketers may not forge, alter or lend the hygiene licence. The measures for the issuance and control of hygiene licence shall be worked out by the administrative departments of public health of the people's governments of the provinces, autonomous regions, or municipalities directly under the Central Government. Article 28 Persons who run a food market of any type shall be responsible for the food hygiene control of the market, set up necessary public sanitary facilities in the market and maintain a good sanitary environment. Article 29 The administrative departments of industry and commerce shall be responsible for the control of food hygiene on urban and rural markets; the administrative departments of public health shall be responsible for the supervision and inspection of food hygiene. Article 30 Imported foods, food additives and containers, packagings, utensils and equipment used for food must comply with the national hygiene standards and the hygiene control regulations. The above-mentioned imports shall be subject to hygiene supervision and inspection by the frontier agencies for hygiene supervision and inspection of imported food. Only those proved to be up to the standards through inspection shall be allowed to enter the territory. The Customs authorities shall grant clearance of goods on the strength of the inspection certificate. When declaring such products for inspection, the importer shall submit the relevant data and inspection reports on the pesticides, additives, fumigants and other such substances used by the exporting country (region). The imports mentioned in the first paragraph shall be subject to inspection in accordance with the national hygiene standards. In the absence of the national hygiene standards for such imports, the importer must provide the hygiene evaluation data prepared by the health authorities or organization of the exporting country (region) to the frontier agencies for hygiene supervision and inspection of imported food for examination and inspection and such data shall also be reported to the administrative department of public health under the State Council for approval. Article 31 Foods for export shall be subject to hygiene supervision and inspection by the national inspection agency for import and export commodities. The Customs authorities shall grant clearance of export commodities on the basis of the certificates issued by the national inspection agency for import and export commodities.
Chapter VII
Food Hygiene Supervision
Article 32 The administrative departments of public health of the
local people's governments at or above the county level shall exercise
their functions and duties for food hygiene supervision within the scope
of their jurisdiction. The agencies for food hygiene supervision set up by the administrative departments of railways and communications shall exercise their functions and duties for food hygiene supervision jointly prescribed by the administrative departments of public health under the State Council and other relevant departments under the State Council. Article 33 The duties for food hygiene supervision shall be as follows: (1) to provide monitoring, inspection and technical guidance for food hygiene; (2) to contribute to the training of personnel for food production and marketing and to supervise the medical examination of such personnel; (3) to disseminate knowledge of food hygiene and nutrition, provide appraisals of food hygiene and publicize the existing situation in food hygiene; (4) to conduct hygiene inspection of sites selected or designs made for construction, extension or renovation projects of enterprises engaged in food production or marketing and participate in the inspection and acceptance of finished projects; (5) to undertake investigation of accidents involving food poisoning or food contamination and take measures of control; (6) to make supervision and inspection rounds to see whether any act is committed against this Law; (7) to pursue investigation of the responsibility of persons who violate this Law and impose administrative punishment on them according to law; (8) to take charge of other matters that concern food hygiene supervision. Article 34 The administrative departments of public health of the people's governments at or above the county level shall be manned with food hygiene supervisors. Such supervisors shall be qualified professionals and issued with such certificates by the administrative departments of public health at the corresponding levels. The food hygiene supervisors appointed by departments in charge of railways and communications agencies shall be issued with the certificates by the competent authorities at a higher level. Article 35 Food hygiene supervisors shall carry out the tasks assigned to them by the administrative department of public health. Food hygiene supervisors shall enforce laws impartially, be loyal to their duties and may not seek personal gain by taking advantage of their office. While carrying out their tasks, food hygiene supervisors may obtain information from the food producers or marketers, request necessary data, enter production or marketing premises to inspect them, and get free samples in accordance with regulations. The producers or marketers may not turn down such requests or hold back any information. Food hygiene supervisors shall be obliged to keep confidential any technical data provided by the producers or marketers. Article 36 The administrative department of public health under the State Council and those of the people's governments of the provinces, autonomous regions, or municipalities directly under the Central Government may, if the need arises, assign qualified units as units for food hygiene inspection; these units shall undertake food hygiene inspection and provide inspection reports. Article 37 The administrative department of public health of the local people's governments at or above the county level may adopt the following temporary measures of control over the food producer or marketer when a food poisoning accident has occurred or when there is evidence of a potential food poisoning accident: (1) to seal up the food and its raw materials that have caused food poisoning or that are likely to cause food poisoning; (2) to seal up the contaminated utensils used for food and order the food producer or marketer to have them cleaned and disinfected. The food that is found to be contaminated after inspection shall be destroyed, while the food that is found not contaminated shall be unsealed. Article 38 The units where food poisoning accidents have occurred and the units that have admitted the victims for medical treatment shall, in addition to taking rescue measures, submit prompt reports to the local administrative departments of public health in accordance with relevant State regulations. The administrative department of public health of a local people's government at or above the county level shall, upon receipt of such report, conduct prompt investigation and handle the matter and adopt control measures.
Chapter VIII
Legal Responsibility
Article 39 Whoever, in violation of this Law, produces or markets
food which is not up to the hygiene standards, thus causing an accident
of food poisoning or resulting in a disease caused by food-borne
bacteria, shall be ordered to stop such production or marketing; the
food causing such food poisoning or disease shall be destroyed; the
illegal gains shall be confiscated and a penalty of not less than one
time and not more than five times the illegal gains shall concurrently
be imposed; if there are no illegal gains, a penalty of not less than
1,000 yuan and not more than 50,000 yuan shall be imposed. Whoever, in violation of this Law, produces or markets food which is not up to the hygiene standards, thus causing a serious accident of food poisoning or resulting in a disease caused by food-borne bacteria, and seriously harming human health, or adulterates food he produces or markets with toxic or harmful non-food raw materials, shall be investigated for criminal responsibility according to law. If a person commits any of the acts mentioned in this Article, his hygiene licence shall be revoked. Article 40 If anyone, in violation of this Law, engages in food production or marketing without obtaining a hygiene licence or with a forged hygiene licence, such production or marketing shall be banned; the illegal gains shall be confiscated and a penalty of not less than one time and not more than five times the illegal income shall concurrently be imposed; if there are no illegal gains, a penalty of not less than 500 yuan and not more than 30,000 yuan shall be imposed. If anyone alters or lends his hygiene licence, his hygiene licence and the illegal gains shall be confiscated; and a penalty of not less than one time and not more than three times the illegal gains shall concurrently be imposed; if there are no illegal gains, a penalty of not less than 500 yuan and not more than 10,000 yuan shall be imposed. Article 41 If, in violation of this Law, any food producer or marketer does not comply with the hygiene requirements, he shall be ordered to set it right and given a disciplinary warning, and a penalty of not more than 5,000 yuan may be imposed; if he refuses to set it right or other serious circumstances are involved, his hygiene licence shall be revoked. Article 42 If anyone, in violation of this Law, produces or markets food the production and marketing of which is prohibited, he shall be ordered to stop producing or marketing such food, a public announcement shall be made immediately to recall the sold food and the food shall be destroyed; the illegal gains shall be confiscated and a penalty of not less than one time and not more than five times the illegal gains shall concurrently be imposed; if there are no illegal gains, a penalty of not less than 1,000 yuan and not more than 50,000 yuan shall be imposed; if the offence is serious, the offender's hygiene licence shall be revoked. Article 43 If anyone, in violation of this Law, produces or markets the principal and supplementary foods intended specially for infants and preschool children which do not conform to the nutritive and hygiene standards, he shall be ordered to stop producing and marketing such foods, a public announcement shall be made immediately to recall the sold foods and the foods shall be destroyed; the illegal gains shall be confiscated and a penalty of not less than one time and not more than five times the illegal gains shall concurrently be imposed; if there are no illegal gains, a penalty of not less than 1,000 yuan and not more than 50,000 yuan shall be imposed; if the offence is serious, the offender's hygiene licence shall be revoked. Article 44 If anyone, in violation of this Law, produces, markets or uses the food additives, food containers, packagings, utensils and equipment used for food as well as the detergents and disinfectants which do not conform to the hygiene standards and the hygiene control regulations, he shall be ordered to stop producing and using them; the illegal gains shall be confiscated and a penalty of not less than one time and not more than three times the illegal gains shall concurrently be imposed; if there are no illegal gains, a penalty of not more than 5,000 yuan shall be imposed. Article 45 If anyone, in violation of this Law, produces or markets the food indicated to have specific health functions without examination and approval by the administrative department of public health under the State Council, or if the product description of such food provides false information, he shall be ordered to stop producing or marketing such food, the illegal gains shall be confiscated and a penalty of not less than one time and not more than five times the illegal gains shall concurrently be imposed; if there are no illegal gains, a penalty of not less than 1,000 yuan and not more than 50,000 yuan shall be imposed; if the offence is serious, the offender's hygiene licence shall be revoked. Article 46 If anyone, in violation of this Law, does not indicate or falsely indicates specified matters such as the date of manufacture and the date of expiration for guaranteed quality in the labels of packages of the standardized packaged food or food additives or in the product descriptions, or in violation of the regulations, does not have labels in the Chinese language, he shall be ordered to set it right and a penalty of not less than 500 yuan and not more than 10,000 yuan may concurrently be imposed. Article 47 If a food producer or marketer, in violation of this Law, engages in food production or marketing without obtaining a health certificate, or if the producers or marketers who suffer from diseases and may not contact with ready-to-eat foods are not transferred to other posts according to relevant regulations, they shall be ordered to set it right and a penalty of not more than 5,000 yuan may be imposed. Article 48 If anyone, in violation of this Law, causes an accident of food poisoning or a disease engendered by food-borne bacteria or causes harm to another person by other acts against this Law, he shall bear the civil liability for compensation according to law. Article 49 The administrative punishment provided in this Law shall be decided by the administrative department of public health of a local people's government at or above the county level. Other authorities exercising the power of food hygiene supervision as provided by this Law shall, within the stipulated scope of functions and duties, make decisions on administrative punishment in accordance with the provisions of this Law. Article 50 If a party is not satisfied with the decision on administrative punishment, he may, within 15 days from receipt of the notice of punishment, apply for reconsideration to the organ at the next higher level over the one that has made the decision. The party may also directly bring a suit in a People's Court within 15 days from receipt of the said notice. The reconsideration organ shall, within 15 days from receipt of the application for reconsideration, make a reconsideration decision. If the party concerned is not satisfied with the reconsideration decision, he may, within 15 days from receipt of the reconsideration decision, bring a suit in a People's Court. If a party neither applies for reconsideration, nor brings a suit in a People's Court within the time limit, nor execute the decision on administrative punishment, the organ that has made the decision may apply to a People's Court for compulsory execution. Article 51 If an administrative department of public health, in violation of this Law, issues hygiene licences to producers or marketers not meeting the requirements, the persons who are directly responsible for the offence shall be given administrative sanctions; those who accept bribes, if the case constitutes a crime, shall be investigated for criminal responsibility in accordance with law. Article 52 Food hygiene supervisors and administrators who by abusing their power, neglecting their duties or engaging in malpractice for personal gain, cause a major accident, which constitutes a crime, shall be investigated for criminal responsibility in accordance with law; if the offence does not constitute a crime, the offender shall be given administrative sanctions according to law. Article 53 Whoever prevents, by force or intimidation, food hygiene supervisors or administrators from performing their duties according to law shall be investigated for criminal responsibility in accordance with law; whoever prevents or obstructs, without resorting to force or intimidation, food hygiene supervisors or administrators from performing their duties according to law shall be punished by the public security organs in accordance with the Regulations on Administrative Penalties for Public Security.
Chapter IX
Supplementary Provisions
Article 54 For the purpose of this Law, the definitions of the following terms are: "Food" means any finished product or raw materials provided for people to eat or drink, as well as any product that has traditionally served as both food and medicament, with the exception of products used solely for medical purposes. "Food additive" means any synthetic compound or natural substance put into food to improve its quality, color, fragrance or taste, or for the sake of preservation or processing. "Food fortifier" means any natural or artificial food additive belonging to the category of natural nutrients that is put into food to increase its nutritive value. "Containers and packagings use for food" means products of various materials including paper, bamboo, wood, metal, enamelware, ceramics, plastics, rubber, natural fibres, synthetic fibres and glass that are used to wrap or contain food, as well as paints or coatings that come in direct contact with food. "Utensils and equipment used for food" means apparatus including machinery, piping, conveyor belts, containers, utensils and tableware that come in direct contact with food in the course of food production or marketing. "Food production or marketing" means all operations in the production of food (other than planting and breeding) and activities such as the gathering, purchase, processing, storage, transport, display, supply and sale of food. "Producers or marketers of food" means all units or individuals involved in food production or marketing, including workers' dining halls and food vendors. Article 55 Measures for the administration of food for export shall be formulated separately by the national import and export commodities inspection department in conjunction with the administrative department of public health and other relevant administrative departments under the State Council. Article 56 Hygiene control measures for food specially used or supplied for its own use by the Army shall be formulated by the Central Military Commission in accordance with this Law. Article 57 This Law shall come into force as of the date of promulgation. The Food Hygiene Law of the People's Republic of China (for trial implementation) shall be annulled on the same date.
Law of the People's Republic of China on Import and Export Commodity Inspection
(Adopted at the Sixth Meeting of the Standing Committee of
the Seventh National People's Congress on February 21, 1989, amended
according to the Decision on Amending the Law of the People's Republic
of China on Import and Export Commodity Inspection of the 27th Meeting
of the Standing Committee of the Ninth National People's Congress on
April 28, 2002)
Chapter I General Provisions
Article 1 This Law is enacted with a view to strengthening the
inspection of import and export commodities，ensuring the quality of
import and export commodities， protecting the lawful rights and
interests of the parties involved in foreign trade， and promoting the
smooth development of China's economic and trade relations with foreign
countries.
Article 2 The State Council shall establish an Administration for Import and Export Commodity Inspection （hereinafter referred to as the State Administration for Commodity Inspection）， which shall be in charge of the inspection of import and export commodities throughout the country. The local import and export commodity inspection authorities （hereinafter referred to as the commodity inspection authorities） set up by the State Administration for Commodity Inspection shall be responsible for the inspection of import and export commodities within areas under their jurisdiction. Article 3 The commodity inspection authorities and other inspection organizations designated by the State Administration for Commodity Inspection and the commodity inspection authorities shall， in accordance with the law， perform the inspection of import and export commodities. Article 4 The State Administration for Commodity Inspection shall， in the light of the needs in the development of foreign trade， make， adjust and publish a List of Import and Export Commodities Subject to Inspection by the Commodity Inspection Authorities （hereinafter referred to as the List of Commodities）。 Article 5 Import and export commodities which are included in the List of Commodities and import and export commodities subject to inspection by the commodity inspection authorities under other laws or administrative rules and regulations must be inspected by the commodity inspection authorities or inspection organizations designated by the State Administration for Commodity Inspection or the commodity inspection authorities. No permission shall be granted for the sale or use of import commodities specified in the preceding paragraph until they have undergone inspection； and no permission shall be granted for the export of export commodities specified in the preceding paragraph until they have been found to be up to standard through inspection. Import and export commodities specified in the first paragraph of this Article may be exempted from inspection upon the examination and approval of an application from the consignee or consignor by the State Administration for Commodity Inspection. Article 6 Inspection on import and export commodities performed by the commodity inspection authorities shall cover quality， specifications， quantity， weight， packing and the requirements for safety and hygiene. Import and export commodities governed by compulsory standards or other inspection standards which must be complied with as provided for by laws or administrative rules and regulations shall be inspected in accordance with such inspection standards； in the absence of such stipulations， import and export commodities shall be inspected in accordance with the inspection standards agreed upon in the foreign trade contracts. Article 7 Import and export commodities or items subject to inspection by other inspection organizations under laws or administrative rules and regulations shall be inspected in accordance with the provisions of relevant laws or administrative rules and regulations. Article 8 The State Administration for Commodity Inspection and the commodity inspection authorities shall collect information on the inspection of import and export commodities and make it available to the relevant circles.
Chapter II Inspection of Import Commodities
Article 9 For import commodities which are subject to inspection by
the commodity inspection authorities in accordance with this Law， the
consignee must register them with the commodity inspection authorities
located at the port of discharge or the station of arrival. Import
commodities which are included in the List of Commodities shall be
checked and released by the Customs upon presentation of the seal of the
commodity inspection authorities affixed to the Customs declaration.
Article 10 For import commodities which are subject to inspection by the commodity inspection authorities in accordance with this Law， the consignee shall apply to the same authorities for inspection in places and within the time limit specified by them. The commodity inspection authorities shall accomplish the procedures for inspection and issue an inspection certificate within the period of validity of claims prescribed in a foreign trade contract. Article 11 If import commodities other than those which are subject to inspection by the commodity inspection authorities in accordance with this Law are found to be not up to the quality standard， damaged or short on weight or quantity， the consignee shall apply to the commodity inspection authorities for inspection and the issuance of an inspection certificate if such a certificate is necessary for claiming compensation. Article 12 For important import commodities and a complete set of equipment in large size， the consignee shall， in accordance with the terms agreed upon in a foreign trade contract， conduct initial inspection or initial supervision over manufacturing or loading in the exporting country before shipment， while the relevant competent departments shall strengthen their supervision. The commodity inspection authorities may， when necessary， dispatch inspection personnel to take part in such inspection and supervision.
Chapter III Inspection of Export Commodities
Article 13 For export commodities which are subject to inspection
by the commodity inspection authorities in accordance with this Law， the
consignor shall apply to the same authorities for inspection in the
places and within the time limit specified by them. The commodity
inspection authorities shall accomplish the procedures for inspection
and issue a certificate without delaying the prescribed time for
shipment. Export commodities which are included in the List of
Commodities shall be checked and released by the Customs upon
presentation of the inspection certificate or the paper for release
issued by the commodity inspection authorities or the seal of the same
authorities affixed to the Customs declaration.
Article 14 Export commodities which have been inspected and passed by the commodity inspection authorities and for which an inspection certificate or a paper for release has been issued by the same authorities shall be declared for export and shipped out of the country within the time limit specified by the same authorities. Failing to meet the time limit shall entail reapplication for inspection. Article 15 An enterprise manufacturing packagings for dangerous export goods must apply to the commodity inspection authorities for a test of the performance of such packagings. An enterprise producing dangerous export goods must apply to the same authorities for a test of the use of packagings. No permission shall be granted for the export of dangerous goods kept in packagings which have not passed a test. Article 16 For vessel holds or containers used for carrying perishable foods， the carrier or the organization using the containers shall apply for inspection before loading. No permission shall be granted for loading and shipment until the relevant conditions are passed by the inspectors.
Chapter IV Supervision and Administration
Article 17 The commodity inspection authorities may make a random
inspection of import and export commodities beyond those subject to
inspection by the commodity inspection authorities in accordance with
this Law. No permission shall be granted for the export of export
commodities found to be substandard in a random inspection.
Article 18 The commodity inspection authorities may， when necessary， assign inspection personnel to manufacturers of export commodities which are included in the List of Commodities to take part in sup ervision over the quality inspection of export commodities before they leave the factory. Article 19 The commodity inspection authorities may undertake the quality certification of import and export commodities on the basis of agreements signed between the State Administration for Commodity Inspection and the foreign bodies concerned or upon entrustment by the foreign bodies concerned. They may permit the use of quality certification marks on import and export commodities which have been given quality certification. Article 20 The State Administration for Commodity Inspection and the commodity inspection authorities shall， on the basis of the requirements in their inspection， entrust competent inspection organizations at home and abroad with the inspection of import and export commodities after examining their qualifications. Article 21 The State Administration for Commodity Inspection and the Commodity inspection authorities shall exercise supervision over the import and export commodity inspection conducted by the inspection organizations designated or approved by them and may make a random inspection of the commodities which have been inspected by such organization. Article 22 The State shall， when necessary， institute a quality licence system for important import and export commodities and their manufacturers. The specific measures thereof shall be drawn up by the State Administration for Commodity Inspection in conjunction with the relevant competent departments under the State Council. Article 23 The commodity inspection authorities may， when necessary， place commodity inspection marks or sealings on import and export commodities proved to be up to standard through inspection. Article 24 In case an applicant for the inspection of import and export commodities disagrees with the results of inspection presented by the commodity inspection authorities， he may apply for reinspection to the same authorities， to those at the next higher level or to the State Administration for Commodity Inspection. The conclusion on reinspection shall be made by the commodity inspection authorities or the State Administration for Commodity Inspection which has accepted the application for reinspection. Article 25 The commodity inspection authorities， the inspection organizations designated by them and other inspection organizations approved by the State Administration for Commodity Inspection may handle the business of superintending and surveying import and export commodities as entrusted by parties involved in foreign trade or by foreign inspection bodies. The scope of business of superintending and surveying import and export commodities shall cover： inspection of the quality， quantity， weight and packing of import and export commodities； inspection of cargoes with respect to general or particular average； inspection of container cargoes； damage survey of import cargoes； inspection of technical conditions for the shipment of exports； measurement of dead tonnage； certification of the origin or value of exports and other superintending and surveying services.
Chapter V Legal Responsibility
Article 26 Anyone who， in violation of the relevant provisions of
this Law， purposely markets or uses import commodities which are
included in the List of Commodities or subject to inspection by the
commodity inspection authorities in accordance with other laws or
administrative rules and regulations without having such commodities
inspected， or purposely exports export commodities which are included in
the List of Commodities or subject to inspection by the commodity
inspection authorities in accordance with other laws or administrative
rules and regulations without having such commodities inspected and
proved up to standard shall be fined by the commodity inspection
authorities. If the circumstances are serious and cause heavy economic
losses， the criminal responsibility of the personnel directly
responsible shall be investigated by applying mutatis mutandis the
provisions of Article 187 of the Criminal Law.
Anyone who， in violation of the provisions of Article 17 of this Law， purposely exports export commodities which have been found substandard during a random inspection by the commodity inspection authorities， shall be punished in accordance with the provisions of the preceding paragraph. Article 27 If the falsifying or remaking of the certificates or documents， seals or stamps， marks， sealings or quality certification marks for commodity inspection constitutes a crime， the criminal responsibility of the personnel directly responsible shall be investigated by applying mutatis mutandis the provisions of Article 167 of the Criminal Law； if the circumstances are minor， the offender shall be fined by the commodity inspection authorities. Article 28 If a party refuses to accept the punishment decision of the commodity inspection authorities， he may， within 30 days of receiving the notice on the punishment， apply for reconsideration to the same authorities which have made the punishment decision， to those at the next higher level or to the State Administration for Commodity Inspection. If the party refuses to accept the decision on the reconsideration， he may， within 30 days of receiving the notice on the reconsideration decision， bring a suit nor complies with the punishment decision within the prescribed time limit， the commodity inspection authorities which have made the punishment decision shall apply to a court of law for compulsory execution. Article 29 Any functionary of the State Administration for Commodity Inspection or of the commodity inspection authorities or any of the inspection personnel of the inspection organizations designated by the State Administration for Commodity Inspection and the commodity inspection authorities who abuses his power， commits irregularities for the benefit of his relatives or friends， falsifies inspection results or fails to conduct inspection and issue a certificate within the time limit through dereliction shall， depending on the seriousness of the circumstances， be given administrative sanction， or his criminal responsibility shall be investigated according to law.
Chapter VI Supplementary Provisions
Article 30 The commodity inspection authorities and other
inspection organizations shall collect fees according to relevant
provisions for carrying out inspection or performing superintending and
surveying services in accordance with the provisions of this Law. The
procedures for collecting fees shall be drawn up by the State
Administration for Commodity Inspection in conjunction with the
competent departments under the State Council.
Article 31 Rules for the implementation of this Law shall be formulated by the State Administration for Commodity Inspection and shall come into force after being submitted to and approved by the State Council. Article 32 This Law shall come into force as of August 1， 1989. The Regulations of the People's Republic of China on the Inspection of Import and Export Commodities promulgated by the State Council on January 28， 1984 shall be invalidated as of the same date.
Law of the People's Republic of China on
Import and Export Commodity Inspection
(Adopted at the Sixth Meeting of the Standing Committee of the
Seventh National People's Congress on February 21, 1989, amended
according to the Decision on Amending the Law of the People's Republic
of China on Import and Export Commodity Inspection of the 27th Meeting
of the Standing Committee of the Ninth National People's Congress on
April 28, 2002)
Chapter 1 General Provisions
Article 1 This Law is enacted with a view to strengthening the
inspection of import and export commodities, regulating the inspection
of import and export commodities, protecting the public interests and
the lawful rights and interests of the parties involved in import and
export trade, and promoting the smooth development of China 's economic
and trade relations with foreign countries.
Article 2 The State Council shall establish an Administration for Import and Export Commodity Inspection (hereinafter referred to as the State Administration for Commodity Inspection), which shall be in charge of the inspection of import and export commodities throughout the country. The local import and export commodity inspection authorities (hereinafter referred to as the commodity inspection authorities) set up by the State Administration for Commodity Inspection shall be responsible for the inspection of import and export commodities within areas under their jurisdiction. Article 3 The commodity inspection authorities and other inspection bodies licensed by the State Administration for Commodity Inspection shall, in accordance with the law, perform the inspection of import and export commodities. Article 4. The inspection of import and export commodities shall follow the principles of protecting the health and safety of human beings, protecting the life and health of animals or plants, protecting the environment, preventing frauds and safeguarding national security, the State Administration for Commodity Inspection shall make and adjust a Catalog of Import and Export Commodities Subject to Compulsory Inspection (hereinafter referred to as the Catalog), and shall promulgate and implement the Catalog. Article 5 The import and export commodities which are included in the Catalog shall be inspected by the commodity inspection authorities. No permission shall be granted for the sale or use of import commodities specified in the preceding paragraph until they have undergone inspection; and no permission shall be granted for the export of export commodities specified in the preceding paragraph until they have been found to be up to standard through inspection. The import and export commodities specified in the first paragraph of this Article which meet the conditions for exemption of inspection provided for by the State may be exempted from inspection upon the examination and approval of an application from the consignee or consignor by the State Administration for Commodity Inspection. Article 6 The compulsory inspection of import and export commodities shall refer to the assessment of whether the import and export commodities listed in the Catalog meet the compulsory requirements of the State technological criterion. The assessment procedures shall include: sampling, inspecting and checking; evaluating, validating and qualification guaranteeing; registering, recognizing and approving, and the combination of them. Article 7 The import and export commodities listed in the Catalog shall be inspected according to the compulsory requirements of the State technological criterion; and the requirements of State technological criterion shall be formulated timely according to law if there are no such requirements yet, before the formulation is made the inspection shall be carried out by referring to the relevant foreign standards designated by the State Administration for Commodities Inspection. Article 8 The inspection bodies licensed by the State Administration for Commodity Inspection may handle the appraisal in import and export commodity inspection as entrusted by parties involved in foreign trade or by foreign inspection bodies. Article 9 The import and export commodities or inspection items that shall be inspected by other inspection bodies as provided for by laws and administrative regulations shall be dealt with according to the provisions of the relevant laws and administrative regulations. Article 10 The State Administration for Commodity Inspection and the commodity inspection authorities shall promptly collect information on the inspection of import and export commodities and make it available to the relevant circles. The functionary of the State Administration for Commodity Inspection and the commodity inspection authorities shall bear the obligation of keeping the commercial secrets they know when performing the duties of inspection of import and export commodities.
Chapter 2 Inspection of Import Commodities
Article 11 For the import commodities which are subject to compulsory
inspection by the commodity inspection authorities in accordance with
this Law, the consignee or his agent shall report for inspection to the
commodity inspection authorities located at the place of customs
declaration. The customs shall check and release the commodities on the
basis of the certificates of customs clearance issued by the commodities
inspection authorities.
Article 12 For import commodities which are subject to inspection by the commodity inspection authorities in accordance with this Law, the consignee or his agent shall accept the inspection of the import commodities in the places and within the time limit specified by them. The commodity inspection authorities shall accomplish the procedures for inspection and issue an inspection certificate within the period as uniformly prescribed by the State Administration for Commodity Inspection. Article 13 If import commodities other than those which are subject to compulsory inspection by the commodity inspection authorities in accordance with this Law are found to be not up to the quality standard, damaged or short on weight or quantity, the consignee shall apply to the commodity inspection authorities for inspection and the issuance of an inspection certificate if such a certificate is necessary for claiming compensation. Article 14 For important import commodities and a complete set of equipments in large size, the consignee shall, in accordance with the terms agreed upon in a foreign trade contract, conduct initial inspection or initial supervision over manufacturing or loading in the exporting country before shipment, while the relevant competent departments shall strengthen their supervision. The commodity inspection authorities may, when necessary, dispatch inspection personnel to take part in such inspection and supervision.
Chapter 3 Inspection of Export Commodities
Article 15 For export commodities which are subject to compulsory
inspection by the commodity inspection authorities in accordance with
this Law, the consignor or his agent shall apply to the same authorities
for inspection in the places and within the time limit specified by
them. The commodity inspection authorities shall accomplish the
procedures for inspection and issue an inspection certificate within the
time limit as uniformly prescribed by the State Administration for
Commodities Inspection.
The export commodities subject to the compulsory inspection in accordance with this Law shall be checked and released by the Customs upon presentation of the certificate of customs clearance issued by the commodity inspection authorities. Article 16 Export commodities inspected and passed by the commodity inspection authorities and for which an inspection certificate has been issued by the same authorities shall be declared for export and shipped out of the country within the time limit specified by the same authorities. Failing to do so within the time limit, reapplication for inspection shall be needed. Article 17 An enterprise manufacturing packings for dangerous export goods must apply to the commodity inspection authorities for a test of the performance of such packagings. An enterprise producing dangerous export goods must apply to the same authorities for a test of the use of packagings. No permission shall be granted for the export of dangerous goods kept in the packings that have not passed a test. Article 18 For vessel holds or containers used for carrying perishable foods, the carrier or the organization using the containers shall apply for inspection before loading. No permission shall be granted for loading and shipment until the relevant conditions are met.
Chapter 4 Supervision and Administration
Article 19 The commodity inspection authorities shall, according to
the provisions of the State, make a random inspection on the import and
export commodities which are not subject to the compulsory inspection by
the commodity inspection authorities in accordance with this Law.
The State Administration for Commodity Inspection may publicize the result of the random inspection or circulate a notice about it to the relevant departments. Article 20 The commodity inspection authorities may, for the convenience of foreign trade, make supervision over the quality supervision, administration and inspection of the export commodities listed in the Catalog before they leave the factory. Article 21 The agent handling the procedures for declaration for inspection on behalf of the consignee or the consignor of the import and export commodities shall register with the commodity inspection authorities; and shall submit the trust deed to the commodity inspection authorities when handling the procedures. Article 22 The State Administration for Commodity Inspection may, according to the relevant provisions of the State, entrust competent inspection organizations home and abroad with the inspection and test of import and export commodities after examining their qualifications. Article 23 The State Administration for Commodity Inspection and the commodity inspection authorities shall exercise supervision over the import and export commodity inspection and test conducted by the inspection bodies licensed by the State Administration for Commodity Inspection, and may make a random inspection on the commodities that have been inspected by such bodies. Article 24 The State Administration for Commodity Inspection shall, according to the uniform certification system of the State, carry out the certification administration for the relevant import and export commodities. Article 25 The commodity inspection authorities may undertake the quality certification of import and export commodities on the basis of agreements signed between the State Administration for Commodity Inspection and the foreign bodies concerned or upon entrustment by the foreign bodies concerned. They may permit the use of quality certification marks on import and export commodities that have been given quality certification. Article 26 The commodity inspection authorities shall, in accordance with this Law, carry out the certification administration of the import and export commodities subject to the license system, check the certificates and verify whether the certificates and the commodities are consistent with each other. Article 27 The commodity inspection authorities may, when necessary, place commodity inspection marks or sealings on import and export commodities proved to be up to standard through inspection. Article 28 In case an applicant for the inspection of import and export commodities disagrees with the results of inspection presented by the commodity inspection authorities, he may apply for re-inspection to the same authorities, to those at the next higher level or to the State Administration for Commodity Inspection. The conclusion on re-inspection shall be made without delay by the commodity inspection authorities or the State Administration for Commodity Inspection that has accepted the application for re-inspection. Article 29 If a party refuses to accept the conclusion made by the commodity inspection authorities or those at the next higher level, or the punishment decision of the commodity inspection authorities, he may apply for reconsideration according to law, either may he bring a lawsuit. Article 30 When performing duties, the State Administration for Commodity Inspection and the commodity inspection authorities must abide by law and protect the interests of the State, strictly enforce the law and accept the supervision according to their legal powers and legal procedures. The State Administration for Commodity Inspection and the commodity inspection authorities shall, according to the needs of performance of their duties, strengthen the construction of their teams to equip the functionary of commodity inspection with high political level and competency for their work. The functionary of commodity inspection shall accept business training and examinations regularly, and may take the posts and execute the duties only after passing the examinations. The functionary of commodity inspection must be devoted to their duties, serve in a cultured manner, abide by the professional ethics, and may not abuse their powers or seek for their own interests. Article 31 The State Administration for Commodity Inspection and the commodity inspection authorities shall establish and improve the internal supervision system to supervise and inspect the law enforcement carried out by their functionary. The duties of the posts within the commodity inspection authorities responsible for accepting the inspection applications, inspecting, issuing the certificates and releasing, etc. shall be defined definitely, and shall be separated from each other and restrict each other. Article 32 Any entity or individual shall have the right to charge against or impeach the illicit acts or the acts against the disciplines of the State Administration for Commodity Inspection, the commodity inspection authorities and the functionary thereof. The organs that receive the charges and impeaches shall investigate and punish the acts without delay according to the division of their powers and duties, and shall keep secret for the persons filing the charges and impeaches.
Chapter 5 Legal Responsibility
Article 33 If anyone, in violation of the provisions of this Law,
purposely markets or uses import commodities which are subject to
compulsory inspection by the commodity inspection authorities without
having such commodities inspected, or purposely exports export
commodities which are subject to compulsory inspection by the commodity
inspection authorities without having such commodities inspected and
proved up to standard, the illegal gains shall be confiscated by the
commodity inspection authorities, and a fine of not less than 5% but not
more than 20% of the value of the commodities shall be imposed on; if a
crime has been constituted, the criminal responsibilities shall be
investigated for.
Article 34 If anyone, in violation of the relevant provisions of this Law, purposely engages in the appraisal operations for import and export commodity inspection without the approval of the State Administration for Commodity Inspection, the commodity inspection authorities shall order him to stop the illegal operations, confiscate the illegal gains and impose on him a fine of not less than 1 time but not more than 3 times of the illegal gains. Article 35 If anyone imports or exports the commodities that are mixed with mess and fake matters, the fake commodities that are taken as real ones and the substandard commodities that are taken as good ones, or imitates the disqualified import and export commodities as the qualified ones, the commodity inspection authorities shall order him to stop the imports or exports, confiscate the illegal gains and impose on him a fine of not less than 50% but not more than 3 times of the value of the commodities; if a crime has been constituted, the criminal responsibilities shall be investigated for. Article 36 If anyone falsifies, remakes, trades or steals the certificates or documents, seals or stamps, marks, sealing or quality certification marks, he shall be investigated for the criminal responsibility; if the circumstances are not serious enough for criminal punishments, the commodity inspection authorities shall order the offender to correct his acts, confiscate his illegal gains and impose on him a fine below the amount equivalent to the value of the commodities. Article 37 If the functionary of the State Administration for Commodity Inspection, or the commodity inspection authorities, in violation of the provisions of this Law, divulge the commercial secrets they know, they shall be given administrative punishments, and the illegal gains shall be confiscated if there is any; if a crime has been constituted, the criminal responsibility shall be investigated for. Article 38 Any functionary of the State Administration for Commodity Inspection or of the commodity inspection authorities who abuses his power and intentionally create difficulties, commits irregularities for the benefit of his relatives or friends, falsifies inspection results or fails to conduct inspection and issue a certificate within the time limit shall be given administrative sanction; if a crime has been constituted, his criminal responsibility shall be investigated according to law.
Chapter 6 Supplementary Provisions
Article 39 The commodity inspection authorities and other inspection
organizations shall collect fees according to the relevant provisions of
the State for carrying out inspection or performing inspection
appraisal services in accordance with the provisions of this Law.
Article 40 The State Council shall formulate the Regulations for the Implementation according to this Law. Article 41 This Law shall come into force on Aug. 1, 1989.
Law of the People's Republic of China on Agricultural Product Quality Safety
Adopted by the 21st Meeting of the Standing Committee of the 10th National People's Congress on April 29, 2006 and effective as of November 1, 2006
Chapter I General Provisions
Article 1 The present Law is formulated in order to guarantee the
quality safety of agricultural products, maintain the health of the
general public and promote the development of agriculture and rural
economy.
Article 2 The term "agricultural products" as mentioned in the present Law refers to primary products sourced from agriculture, that is to say, the plants, animals, microorganisms and their products which are obtained from agricultural activities. The term "agricultural product quality safety" as mentioned in the present Law means that the quality of an agricultural product meets the requirements of ensuring human health and safety. Article 3 The administrative department of agriculture of the people's government at the county level or above shall be responsible for the supervision and inspection of agricultural product quality safety; while the relevant departments of the people's government at the county level or above shall, in accordance with the scope of duties, be responsible for the relevant work on agricultural product quality safety respectively. Article 4 The people's government at the county level or above shall include agricultural product quality safety administration into the national economic and social development planning at the present level and offer funds of agricultural product quality safety for carrying out the work of agricultural product quality safety. Article 5 The local people's government at the county level or above shall exercise the unified leadership over and coordinate the work of agricultural product quality safety under their own jurisdiction, adopt measures to set up and perfect an agricultural product quality safety service system and improve the level of agricultural product quality safety. Article 6 The administrative department of agriculture of the State Council shall set up an agricultural product quality safety risk evaluation experts committee consisting of experts in relevant areas, in order to carry out risk analysis and evaluation of the potential harms which might affect the agricultural product quality safety. The administrative department of agriculture of the State Council shall adopt relevant administrative measures in accordance with the risk evaluation results of agricultural product quality safety and inform the relevant departments of the State Council of the risk evaluation results of agricultural product quality safety in a timely manner. Article 7 The administrative department of agriculture of the State Council and the administrative department of agriculture of the people's government of each province, autonomous region or municipality directly under the Central Government shall publish relative information on the situation of agricultural product quality safety according to their legal authority. Article 8 The state guides and popularizes standardized production of agricultural products, encourages and supports production of high-quality agricultural products, and prohibits production and sales of agricultural products which do not meet the agricultural product quality safety criteria prescribed by the state. Article 9 The state supports scientific and technological researches on agricultural product quality safety, implements scientific quality safety administration methods and promotes advanced and safe production technologies. Article 10 The people's government at any level and the relevant departments shall strengthen publicity of knowledge on agricultural product quality safety, improve the consciousness on agricultural product quality safety of the general public, guide producers and sellers of agricultural products to intensify quality safety management and guarantee the safety of agricultural product consumption.
Chapter II Agricultural Product Quality Safety Criteria
Article 11 The state establishes and improves the system of
agricultural product quality safety criteria. The agricultural product
quality safety criteria shall be compulsory technical norms.
The agricultural product quality safety criteria shall be formulated and promulgated in light of relative laws and administrative regulations. Article 12 When formulating the agricultural product quality safety criteria, the relevant departments shall take into full consideration the risk evaluation results of agricultural product quality safety and give audience to the opinions of producers, sellers and consumers of agricultural products, in order to guarantee the consumption safety. Article 13 The agricultural product quality safety criteria shall be revised in a timely manner based on the scientific and technological development level and the requirements of agricultural product quality safety. Article 14 The agricultural product quality safety criteria shall be organized to implement by the administrative department of agriculture together with other relevant departments.
Chapter III Producing Areas of Agricultural Products
Article 15 The administrative department of agriculture of a local
people's government at the county level or above shall, as per the
requirements of agricultural product quality safety as well as in
accordance with factors such as variety characters of the agricultural
products and poisonous and harmful substances in the atmosphere, soil
and water body of the production area, propose areas banned from
production which it considers unsuitable for production of certain
agricultural products, and publicize such areas upon approval of the
people's government at the same level. The specific measures shall be
formulated by the administrative department of agriculture of the State
Council together with the administrative department of environmental
protection of the State Council.
The adjustment of areas banned from production of agricultural products shall be made in light of the procedures prescribed in the preceding paragraph. Article 16 The people's government at the county level or above shall adopt measures to enhance construction of agricultural product bases and improve the production conditions of agricultural products. Measures shall be taken by the administrative department of agriculture of the people's government at the county level or above to propel construction of comprehensive demonstration areas for standardized production, demonstration farms, breeding areas and areas without prescribed epidemic animal or plant diseases, so as to guarantee the agricultural products quality safety. Article 17 It is prohibited to produce, fish or collect edible agricultural products or to establish production bases of agricultural products in the areas where poisonous and harmful substances are in excess of the prescribed standards. Article 18 It is prohibited to discharge or dump waste water, waste gas, solid wastes or other poisonous and harmful substances to producing areas of agricultural products in violation of laws and regulations. The water used for agricultural production and the solid wastes used as fertilizers shall meet the criteria of the state provisions. Article 19 Such chemical products as chemical fertilizers, pesticides, veterinary drugs and agricultural films shall be used in a reasonable way by producers of agricultural products to prevent such chemical products from polluting the producing areas of agricultural products.
Chapter IV Production of Agricultural Products
Article 20 The requirements on production technologies and
operational rules shall be constituted by the administrative department
of agriculture of the State Council and the administrative department of
agriculture of the people's government of each province, autonomous
region or municipality directly under the Central Government so as to
guarantee the agricultural product quality safety. The administrative
department of agriculture of each people's government at the county
level or above shall strengthen its guidance to the production of
agricultural products.
Article 21 For the pesticides, veterinary drugs, feeds and feed additives, fertilizers and veterinary devices, which might affect agricultural product quality safety, a licensing system shall be carried out in light of relative laws and administrative regulations. The administrative department of agriculture of the State Council and the administrative department of agriculture of the people's government of each province, autonomous region or municipality directly under the Central Government shall, at a regular time schedule , make a random inspection on such agricultural input products as pesticides, veterinary drugs, feeds and feed additives as well as fertilizers, which might endanger the agricultural product quality safety, and shall make public the results. Article 22 The administrative department of agriculture of the people's government at the county level or above shall enhance administration and guidance on the use of agricultural input products, as well as setting up and improving a system for safe use of agricultural input products. Article 23 Agricultural research and education institutions and agricultural technology promotion institutions shall strengthen trainings on quality safety knowledge and skills for producers of agricultural products. Article 24 An enterprise engaging in agricultural production or a professional farmers cooperative economic organization shall set up records on production of agricultural products and the contents as follows shall be included: (1) The names, sources, usage, dosage of agricultural input products in use, the date of using it and the date disusing it; (2) The information on occurrence, prevention and control of animal epidemic diseases as well as plant diseases, pests and disasters; and (3) The date of harvest, slaughter or fishing. The records on agricultural production shall be preserved for two years. Any forgery of records on agricultural production is prohibited. The state encourages other producers engaging in agricultural production to set up records on agricultural production. Article 25 A producer engaging in agricultural production shall, in light of the laws, administrative regulations and provisions of the administrative department of agriculture of the State Council, make use of the agricultural input products in a reasonable way, strictly carring out the provisions on safe intervals or withdrawal period for using agricultural input products, so as to prevent the agricultural input products from endangering the agricultural product quality safety. Any agricultural input product prohibited by explicit order of the state shall be forbidden to be used in the process of agricultural production. Article 26 An enterprise engaging in agricultural production or a professional farmers cooperative economic organization shall check the agricultural product quality safety either by itself or by entrusting a testing institution. It is prohibited to sell any agricultural product found from the test to fail to comply with the agricultural product quality safety criteria . Article 27 A professional farmers cooperative economic organization or an agricultural products industry association shall offer its members production technology services in a timely manner, set up agricultural product quality safety management systems, perfect the agricultural product quality safety control system and strengthen self-disciplinary management.
Chapter V Packages and Marks of Agricultural Products
Article 28 Where the agricultural products sold by an enterprise
engaging in production of agricultural products, a professional farmers
cooperative economic organization or an entity or an individual engaging
in purchase of agricultural products are required in accordance with
relevant provisions to be packed or be attached with marks, they may not
be sold until they have been packed or attached with marks. Such
contents as the product name, producing area, producer, date of
production, warranty period and product quality grade shall be indicated
on the packages or marks, in accordance with related provisions; if any
additive is used, the name of the additive shall also be indicated in
accordance with the provisions. The specific measures shall be
instituted by the administrative department of agriculture of the State
Council.
Article 29 The materials used in package, preservation, storage and transport of agricultural products, such as preservatives, antiseptics, additives, etc., shall comply with the relevant compulsory technical norms of the state. Article 30 The agricultural products belonging to agricultural transgenic organisms shall be marked in light of relative provisions on the administration of the safety of agricultural transgenic organisms. Article 31 The animals, plants and their products required to be quarantined in accordance with the law shall be attached with quarantine marks of fitness and quarantine certificates of fitness. Article 32 The on-sale agricultural products must meet the agricultural product quality safety criteria, and the producers may submit applications for using pollution-free marks on agricultural products. If the quality of the agricultural products complies with the criteria prescribed by the state for high-quality agricultural products, the producers may submit applications for using commensurate quality marks on agricultural products. It is prohibited to imitate the quality marks on agricultural products as prescribed in the preceding paragraph.
Chapter VI Supervision and Inspection
Article 33 An agricultural product under any of the following circumstances shall not be sold:
(1) It contains any pesticide, veterinary drug or other chemical substance prohibited by the state from being used; (2) The remnant of chemical substance such as pesticide and veterinary drug or the contained poisonous and harmful substance such as heavy metal, etc. does not comply with the agricultural product quality safety criteria; (3) The contained pathogenic parasites, microorganisms or biological toxin does not conform to the agricultural product quality safety criteria; (4) The material in use such as preservative, antiseptic or additive, etc. does not conform to the relative compulsory technical norms of the state; or (5) Other circumstances under which it does not conform to the agricultural product quality safety criteria. Article 34 The state sets up an agricultural product quality safety monitoring system. The administrative department of agriculture of the people's government at the county level or above shall, in accordance with the requirements for guaranteeing the agricultural product quality safety, make an plan of monitoring the agricultural product quality safety, organize the implementation thereof and supervise and make a random inspection on the agricultural products under production or on sale in the market. The administrative department of agriculture of the State Council or the administrative department of agriculture of the people's government of each province, autonomous region or municipality directly under the Central Government shall make public the results according to its legal authority. For a supervisory test on a random inspection, the department concerned shall entrust an agricultural product quality safety test institution that meets the conditions in Article 35 of the present Law, but shall not charge any fee from the party to be tested. The number of the samples shall not exceed the quantity prescribed by the administrative department of agriculture of the State Council. For the agricultural products which are subject to supervision of the administrative departments of agriculture at higher levels by sampling, the administrative departments of agriculture at lower levels shall not make an sampling again. Article 35 For the agricultural product quality safety test, the existing qualified test institutions shall be given full consideration. An institution engaging in agricultural product quality safety test must possess commensurate conditions and capacities for test and shall be qualified and pass the assessment of the administrative department of agriculture of the people's government at the provincial level or above or its authorized department. The detailed measures shall be instituted by the administrative department of agriculture of the State Council. An agricultural product quality safety test institution shall be found qualified from metrological certification in accordance with law. Article 36 Where a producer or seller of agricultural products has any objection to the result of random inspection, it may, within five days as of the receipt of the test result, submit an application to the administrative department of agriculture that organizes the implementation of the random inspection on agricultural product quality safety or to the administrative departments of agriculture at higher levels for a re-test. When the speedy test method ascertained by the administrative department of agriculture of the State Council together with the relevant departments is adopted for the random inspection on agricultural product quality safety, if the party that is tested has any objection to the test result, it may, within four hours as of the receipt of the test result, submit an application for a re-test. The re-test shall not be carried out in a speedy method. If the testing institution causes any damages to the party concerned because of a wrong test result, it shall undertake liabilities for compensation in light of the law. Article 37 An agricultural product wholesale market shall establish or entrust an agricultural product quality safety test institution to test the quality safety of the agricultural products sold in the market by random inspection; when finding any inconformity with the agricultural product quality safety criteria, it shall require the seller to immediately stop the sale and report to the administrative department of agriculture. An enterprise engaging in sale of agricultural products shall, for the agricultural products it sells, set up and improve the rules on inspection and acceptance of purchased goods; any agricultural product that is found from the inspection to fail to comply with the quality safety criteria shall not be sold. Article 38 The state encourages entities and individuals to carry out public supervision over the agricultural product quality safety. Any entity or individual shall have the right to impeach, expose or accuse any act violating the present Law. After receipt of relevant impeachment, exposure or accusation, the relevant department shall deal with the case in a timely manner. Article 39 The administrative department of agriculture of the people's government at the county level or above may, in its agricultural product quality safety supervision and inspection, make on-site inspections on the agricultural products under production or on sale, investigate and know about the relative information on agricultural product quality safety, consult to and photocopy the records and other information concerning agricultural product quality safety; and shall have the right to seal up or distrain the agricultural products which are found from test to fail to comply with the agricultural product quality safety criteria. Article 40 When an agricultural product quality safety accident occurs, the concerned entities and individuals shall take control measures and report to the local people's government at the township level and the administrative department of agriculture of the people's government at the county level in a timely manner. The organ receiving the report shall deal with the accident in a timely manner and report to the people's government at the higher level and other relative departments. When a significant agricultural product quality safety accident occurs, the administrative department of agriculture shall inform the food and drug administrative department at the same level of the accident in a timely manner. Article 41 In the agricultural product quality safety supervision and administration, if the administrative department of agriculture of a people's government at the county level or above finds that an agricultural product is under any of the circumstances listed in Article 33 of the present Law, it shall, on the basis of the requirements of the system for ascertaining liabilities of agricultural product quality safety, find out the liable persons and decide punishment in light of the law or propose punishment suggestions. Article 42 An imported agricultural product must be inspected in accordance with the agricultural product quality safety criteria prescribed by the state. If the relevant agricultural product quality safety criteria have not been formulated, the department concerned shall formulate them in light of the law in a timely manner and may, before finishing formulating such criteria, inspect the imported agricultural product by referring to the relevant foreign criteria designated by the relevant department of the state. Article 43 If any agricultural product quality safety supervisory and administrative staff member does not carry out his supervisory duties in light of the law or abuses his power, he shall be given administrative sanctions according to law.
Chapter VII Legal Liabilities
Article 44 If an agricultural product quality safety test institution
forges a test result, it shall be ordered to make correction. Its
illegal proceeds shall be confiscated and in addition, it shall be
charged a fine not less than 50,000 yuan and not more than 100,000 yuan.
The person-in-charge directly responsible and other persons held direct
liabilities shall be charged a fine not less than 10,000 yuan and not
more than 50,000 yuan respectively. If the circumstances are serious,
its test qualification shall be revoked. If it causes any damages, it
shall undertake liabilities for compensation in light of the law.
If an agricultural product quality safety test institution issues an untrue test result and causes any damages, it shall undertake liabilities for compensation in light of the law; if it causes any heavy damages, its test qualification shall be revoked in addition. Article 45 Whoever violates laws or regulations by discharging or dumping waste water, waste gas, solid wastes or other poisonous and harmful substances to a producing area of agricultural products shall be penalized in light of the relative environmental protection laws and regulations; if he causes any damage, he shall undertake liabilities for compensation in light of the law. Article 46 Whoever violates laws, administrative regulations or any provisions of the administrative department of agriculture of the State Council in using agricultural input products shall be penalized in light of the relative laws and administrative regulations. Article 47 If an enterprise engaging in agricultural production or a professional farmers cooperative economic organization fails to establish or preserve records on agricultural production according to related provisions, or forges records on agricultural production, it shall be ordered to make correction within a time limit; if it fails to make correction within the time limit, it may be fined not more than 2,000 yuan. Article 48 Whoever violates the provisions prescribed in Article 28 of the present Law by failing to follow the provisions to pack or mark the agricultural products for sale shall be ordered to make correction within a time limit; if he fails to make correction within the time limit, he may be fined not more than 2,000 yuan. Article 49 If any of the circumstances under Item (4) of Article 33 of the present Law arises and the material in use such as the preservative, antiseptic or additive, etc. does not comply with the relevant compulsory technical norms of the state, the party concerned shall be ordered to stop selling the agricultural products and shall make innocuous treatment of the polluted agricultural products. If no innocuous treatment can be made, the agricultural products shall be destroyed under supervision; at the same time, his illegal income shall be confiscated and he shall be fined not less than 2,000 yuan and not more than 20,000 yuan, in addition. Article 50 If agricultural products sold by an enterprise engaging in agricultural production or a professional farmers cooperative economic organization are under any of the circumstances listed in Items (1) through (3) or Item (5) of Article 33 of the present Law, the said entity shall be ordered to stop selling the products, replevy the sold agricultural products and make innocuous treatment over or destroy the illegally sold agricultural products under supervision; at the same time, its illegal income shall be confiscated and it shall be fined not less than 2,000 yuan and not more than 20,000 yuan, in addition. If agricultural products sold by an enterprise engaging in sale of agricultural products are under any of the circumstances enumerated in the preceding paragraph, the said enterprise shall be punished in light of the preceding paragraph. If on-sale agricultural products in an agricultural product wholesale market are under any of the circumstances listed in Paragraph 1 of this article, the agricultural products on illegal sale shall be dealt with in light of Paragraph 1 and the seller of the agricultural products shall be penalized in light of Paragraph 1. If an agricultural product wholesale market violates Paragraph 1 of Article 37 of the present Law, it shall be ordered to make correction and be fined not less than 2,000 yuan and not more than 20,000 yuan. Article 51 Whoever violates Article 32 of the present Law by imitating the quality marks on an agricultural product shall be ordered to make correction, his illegal proceeds shall be confiscated and he shall be fined not less than 2,000 yuan and not more than 20,000 yuan. Article 52 The penalties prescribed in Article 44, Articles 47 through 49, Paragraphs 1 and 4 of Article 50 and Article 51 of the present Law shall be decided by the administrative department of agriculture of the people's government at the county level or above; while the penalties prescribed in Paragraph 2 and Paragraph 3 of Article 50 shall be decided by the administrative department for industry and commerce. If any law has different provisions on an administrative penalty or the organ who has the power to make penalty, such provisions shall prevail, but the same illegal act shall not be penalized for twice or more. Article 53 If someone violates the present Law and has committed a crime, investigations shall be conducted to determine his criminal liabilities in light of the law. Article 54 If anyone who produces or sells the agricultural products enumerated in Article 33 of the present Law and causes any damages to the consumers, it shall undertake liabilities for compensation in light of the law. If any on-sale agricultural product in an agricultural product wholesale market is under the circumstance prescribed in the preceding paragraph, the consumers may claim to the agricultural product wholesale market for compensation; if the producer or seller is held liable, the agricultural product wholesale market shall have the right to make recourse. The consumers concerned may also directly claim to the producer or seller of the agricultural products for compensation.
Chapter VIII Supplementary Provisions
Article 55 The administration on live pig slaughtering shall be carried out in light of the relevant provisions of the state.
Article 56 The present Law shall go into effect as of November 1, 2006.
Regulations on Administration of Veterinary Drugs
(Adopted at the 45th Executive Meeting of the State Council on March 24, 2004, promulgated by Decree No. 404 of the State Council of the People’s Republic of China on April 9, 2004, and effective as of November 1, 2004)
Chapter I General Provisions
Article 1 These
Regulations are formulated for the purpose of strengthening the
administration of veterinary drugs, ensuring the quality of such drugs,
preventing and controlling animal diseases, promoting the development of
breeding industry, and safeguarding human health.
Article 2 Any entity engaged in
research and development, manufacture, distribution, import and export,
use, supervision and administration of veterinary drugs within the
territory of the People’s Republic of China shall comply with these Regulations.
Article 3 The administrative
department for veterinary medicine of the State Council is responsible
for the supervision and administration of veterinary drugs nationwide.
The administrative departments for veterinary
medicine of the local people’s governments at or above the county level
are responsible for the supervision and administration of veterinary
drugs within their respective administrative areas.
Article 4 The State adopts an
administration system for classifying veterinary drugs into prescription
and non-prescription ones. The measures and the specific implementation
procedures of the administration system for classifying veterinary
drugs into prescription and non-prescription ones shall be formulated by
the administrative department for veterinary medicine of the State
Council.
Article 5 The State adopts a system for reserve of veterinary drugs.
In the event of a serious epizootic disease,
calamity or other emergency, the administrative department for
veterinary medicine of the State Council may, for purposes of first aid,
transfer veterinary drugs from the national reserve and, when
necessary, may also transfer veterinary drugs from the reserve of other
quarters.
Chapter II Research and Development of New Veterinary Drugs
Article 6 The State encourages
research and development of new veterinary drugs and protects the
legitimate rights and interests of researchers and developers according
to law.
Article 7 For research and development
of a new veterinary drug, there shall be premises, instruments and
equipment, professional technicians, standards and measures for safety
control commensurate with the research and development work.
For research and development of a new
veterinary drug, safety evaluation shall be conducted. Any institution
to be engaged in safety evaluation of veterinary drugs shall be subject
to accreditation by the administrative department for veterinary
medicine of the State Council, and shall comply with the Good Laboratory
Practice for Non-clinical Laboratory Studies and the Good Clinical
Practice in respect of veterinary drugs.
Article 8 For research and development
of a new veterinary drug, an application attached with a report of
safety evaluation made at the laboratory stage and other pre-clinical
study data on the drug shall, before clinical trials are conducted, be
submitted to the administrative department for veterinary medicine of
the people’s government of the province, autonomous region or
municipality directly under the Central Government, which shall notify
the applicant of the result of examination in writing within 60 working
days from the date it receives the application.
Where the new veterinary drug being researched
and developed is a biological product, an application shall, before
clinical trials are conducted, be submitted to the administrative
department for veterinary medicine of the State Council, which shall
notify the applicant of the result of examination in writing within 60
working days from the date it receives the application.
Where pathogenic microorganisms of Class I are
necessary to be used in the research and development of a new
veterinary drug, conditions laid down by the administrative department
for veterinary medicine of the State Council are, in addition, required
to be met, and the matter shall, prior to the laboratory stage, be
reported to the administrative department for veterinary medicine of the
State Council for approval.
Article 9 When applying to the
administrative department for veterinary medicine of the State Council
for registration of a new veterinary drug after clinical trials are
concluded, the researcher and developer of the drug shall submit a
sample of the drug and the following data:
(1) the name, principal ingredients and physicochemical characteristics;
(2) the method and process of manufacturing, quality standards and analytical method;
(3) results of pharmacological and toxicological tests, the clinical trial report and stability test report; and
(4) the environmental impact report and measures for prevention and control of pollution.
Where the new veterinary drug being researched
and developed is a biological product, the master seed bacteria
(viruses or insects), cell lines and other relevant materials and data
shall, in addition, be provided. The master seed bacteria (viruses or
insects) and cell lines shall be preserved by an institution designated
by the administrative department for veterinary medicine of the State
Council.
Where the new veterinary drug being researched
and developed is to be used in food animals, a residue depletion test
of the drug shall, in addition, be conducted and the data relating to
the withdrawal period, maximum residue limits, residue analytical method
and their basis provided, as is required by the administrative
department for veterinary medicine of the State Council.
The administrative department for veterinary
medicine of the State Council shall, within 10 working days from the
date it receives the application, send the data of the new veterinary
drug, which it decides to accept, to the veterinary drug evaluation
institution established by itself for evaluation, and send the sample of
the new veterinary drug to the test institution designated by itself
for quality retrial, and shall complete the examination within 60
working days from the date it receives the results of evaluation and
quality retrial. If the drug passes the examination, the said department
shall issue a Registration Certificate of New Veterinary Drugs and
publish the quality standards of the drug; if the drug fails to pass the
examination, the department shall notify the applicant thereof in
writing.
Article 10 The State offers protection
to the undisclosed test data and other data, accumulated by the
applicant itself and submitted by it, which concern the veterinary drug
that has been registered according to law and contains a new compound.
Where another entity, without consent of the
applicant of the veterinary drug already registered, applies for
registration of a veterinary drug by using the data specified in the
preceding paragraph, the veterinary drug registration department shall,
within six years from the date the drug is registered, refuse to have it
registered, unless the data submitted by that entity are accumulated by
itself.
The veterinary drug registration department
shall not disclose the data specified in the first paragraph of this
Article, except under the following circumstances:
(1) for the need of public interest; or
(2) where measures have been taken to ensure that the data are protected against illegitimate commercial use.
Chapter III Manufacture of Veterinary Drugs
Article 11 A veterinary
drug manufacturer shall be established in conformity with the national
development programme and policy for the veterinary drug industry and
shall meet the following requirements:
(1) having technical workers in the field of
veterinary science, pharmacy or other relevant sciences commensurate
with manufacture of veterinary drugs;
(2) having premises and facilities commensurate with manufacture of veterinary drugs;
(3) having the quality control and test
institutions, personnel, instruments and equipment commensurate with
manufacture of veterinary drugs;
(4) having a manufacturing environment required for safety and hygiene; and
(5) other requirements for manufacture specified in the Good Manufacturing Practice for Veterinary Drugs.
Only when meeting the requirements specified
in the preceding paragraph may an applicant submit an application, which
is attached with the documents certifying that the requirements
specified in the preceding paragraph are met, to the administrative
department for veterinary medicine of the people’s government of the
province, autonomous region or municipality directly under the Central
Government, which shall, within 20 working days from the date it
receives the application, submit its opinions of verification and
relevant materials to the administrative department for veterinary
medicine of the State Council.
The administrative department for veterinary
medicine of the State Council shall complete the examination within 40
working days from the date it receives the opinions of verification and
relevant materials. If the application passes the examination, the said
department shall issue a Veterinary Drug Manufacturing Licence; if the
application fails to pass the examination, the department shall notify
the applicant thereof in writing. The applicant shall complete the
formalities for business registration on the basis of the Veterinary
Drug Manufacturing Licence.
Article 12 In the Veterinary Drug Manufacturing Licence shall be clearly stated the scope and place of manufacturing, expiry date, the name and address of the legal representative, etc.
A Veterinary Drug Manufacturing Licence
is valid for five years. A manufacturer that needs to continue the
production of veterinary drugs after the expiry date shall, six months
before the expiration of the licence, apply to the original department
that issued the licence for renewal of the Veterinary Drug Manufacturing
Licence.
Article 13 Where intending to change
its scope or place of manufacturing, a veterinary drug manufacturer
shall apply for renewal of the Veterinary Drug Manufacturing Licence in
accordance with the provisions of Article 11 of these Regulations, and
the applicant shall, on the basis of the renewed Veterinary Drug
Manufacturing Licence, complete the formalities for change of business
registration; where intending to change the name of the enterprise or
its legal representative, it shall, within 15 working days after it
completes the formalities for change of business registration, apply to
the original department that issued the licence for renewal of the
Veterinary Drug Manufacturing Licence.
Article 14 A veterinary drug
manufacturer shall conduct production in accordance with the Good
Manufacturing Practice for Veterinary Drugs laid down by the
administrative department for veterinary medicine of the State Council.
The administrative department for veterinary
medicine of the State Council shall supervise and inspect veterinary
drug manufacturers to see whether they meet the requirements of the Good
Manufacturing Practice for Veterinary Drugs and publish the results of
inspection.
Article 15 To produce a veterinary
drug, a veterinary drug manufacturer shall acquire an approval number
for the product verified and issued by the administrative department for
veterinary medicine of the State Council, and such approval number of
the product is valid for five years. The measures for verifying and
issuing such an approval number for the product shall be formulated by
the administrative department for veterinary medicine of the State
Council.
Article 16 A veterinary drug
manufacturer shall conduct production in accordance with the national
standards for veterinary drugs and the manufacturing process approved by
the administrative department for veterinary medicine of the State
Council. When intending to alter the manufacturing process that affects
the quality of a veterinary drug, a veterinary drug manufacturer shall
report the matter to the original approval department for verification
and approval.
A veterinary drug manufacturer shall keep records of production, which shall be complete and accurate.
Article 17 The substances and
excipients used for the production of veterinary drugs shall be up to
the national standards or the quality required for the veterinary drugs
produced.
The immediate packaging materials and containers of veterinary drugs shall meet the requirements for medicinal use.
Article 18 A veterinary drug shall be
subject to quality test before it leaves the manufacturing plant, and it
shall not be released if it does not conform to the quality standards.
A veterinary drug that leaves the manufacturing plant shall bear a certificate of quality.
Manufacturing of counterfeit or substandard veterinary drugs is prohibited.
Article 19 Before being released from
the manufacturing plant, every batch of veterinary biologics
manufactured by a veterinary drug manufacturer shall be subject to
verification by a test institution designated by the administrative
department for veterinary medicine of the State Council, which may
conduct sampling tests, when necessary; those drugs that have not
undergone verification or that have failed to pass the sampling tests
shall not be marketed.
Veterinary biologics needed for compulsory
vaccination shall be produced by enterprises designated by the
administrative department for veterinary medicine of the State Council.
Article 20 A label shall be printed on
or stuck to every package of veterinary drugs, together with a package
leaflet, and with the words “for animal use only” indicated at a
conspicuous place, as is required by the provisions.
No label and package leaflet of a veterinary
drug may be used unless they are approved and published by the
administrative department for veterinary medicine of the State Council.
In the label and package leaflet of a
veterinary drug shall be indicated in Chinese the common name,
ingredients and content, presentation, manufacturer, approval number of
the product (number of the Registration Certificate of an Imported
Veterinary Drug), product batch number, manufacturing date, expiry date,
indications or functions, usage, dosage, withdrawal period,
contraindications, adverse reactions, precautions, conditions for
transportation, storage and preservation of the drug, and other
necessary explanations. The trade name, if any, shall also be indicated.
In addition to the information specified in
the preceding paragraph, precautions prescribed by the administrative
department for veterinary medicine of the State Council shall also be
printed in the labels or package leaflets attached to veterinary
prescription drugs, and for narcotic drugs, psychotropic substances,
toxic drugs and radioactive pharmaceuticals used for animals, a special
sign prescribed by the administrative department for veterinary medicine
of the State Council shall also be printed; moreover, in the labels or
package leaflets attached to veterinary non-prescription drugs shall be
printed the sign for non-prescription drugs prescribed by the
administrative department for veterinary medicine of the State Council.
Article 21 In the light of the need to
ensure the quality and safety of animal products and human health, the
administrative department for veterinary medicine of the State Council
may fix a period of not more than five years for surveillance of a new
veterinary drug, and shall not give approval to another enterprise for
producing or importing the same drug during this period. During the
surveillance period, the manufacturer shall collect data regarding the
therapeutic efficacy and adverse reactions of the new veterinary drug,
and submit them to the administrative department for veterinary medicine
of the State Council without delay.
Chapter IV Distribution of Veterinary Drugs
Article 22 A veterinary drug distributor shall meet the following requirements:
(1) having veterinary drug technical workers commensurate with distribution of veterinary drugs;
(2) having the business operation premises,
equipment and storage facilities commensurate with distribution of
veterinary drugs;
(3) having the quality control institution or personnel commensurate with distribution of veterinary drugs; and
(4) other distribution conditions laid down in the Good Sale Practice for Veterinary Drugs.
Only when meeting the requirements specified
in the preceding paragraph may an applicant submit an application, which
is attached with the documents certifying that the requirements
specified in the preceding paragraph are met, to the administrative
department for veterinary medicine of the people’s government of the
city or county; an entity that intends to distribute veterinary
biologics shall submit an application, which is attached with the
documents certifying that the requirements specified in the preceding
paragraph are met, to the administrative department for veterinary
medicine of the people’s government of the province, autonomous region
or municipality directly under the Central Government.
The administrative department for veterinary
medicine of the local people’s government at or above the county level
shall complete the examination within 30 working days from the date it
receives the application. If the application passes the examination, the
said department shall issue a Veterinary Drug Distribution Licence; if
the application fails to pass the examination, the department shall
notify the applicant thereof in writing. The applicant shall complete
the formalities for business registration on the basis of the Veterinary
Drug Distribution Licence.
Article 23 In the Veterinary Drug Distribution Licence shall be clearly stated the scope of distribution, place of business, expiry date, the name and address of the legal representative, etc.
A Veterinary Drug Distribution Licence
is valid for five years. A distributor that needs to continue the
distribution of veterinary drugs after the expiry date shall, six months
before the expiration of the licence, apply to the original department
that issued the licence for renewal of the Veterinary Drug Distribution
Licence.
Article 24 Where intending to change
its scope of distribution or place of business, a veterinary drug
distributor shall apply for renewal of the Veterinary Drug Distribution
Licence in accordance with the provisions of Article 22 of these
Regulations, and the applicant shall, on the basis of the renewed
Veterinary Drug Distribution Licence, complete the formalities for
change of business registration; where intending to change the name of
the enterprise or its legal representative, it shall, within 15 working
days after it completes the formalities for change of business
registration, apply to the original department that issued the licence
for renewal of the Veterinary Drug Distribution Licence.
Article 25 A veterinary drug
distributor shall comply with the Good Sale Practice for Veterinary
Drugs laid down by the administrative department for veterinary medicine
of the State Council.
The administrative department for veterinary
medicine of the local people’s government at or above the county level
shall supervise and inspect veterinary drug distributors to see whether
they meet the requirements of the Good Sale Practice for Veterinary
Drugs and publish the results of inspection.
Article 26 When purchasing a
veterinary drug, a veterinary drug distributor shall have the product
checked against its label, package leaflet and certificate of quality.
Article 27 A veterinary drug
distributor shall provide its customers with information about the
indications and functions, usage, dosage and precautions of the
veterinary drug. When selling a veterinary prescription drug, it shall
comply with the measures for administration of veterinary prescription
drugs.
When selling crude Chinese medicines to be used for animals, a veterinary drug distributor shall indicate their origin.
A veterinary drug distributor is prohibited
from distributing drugs for human use, as well as counterfeit and
substandard veterinary drugs.
Article 28 When purchasing and selling
veterinary drugs, a veterinary drug distributor shall keep purchase and
sale records. In such records shall be indicated the trade name, common
name, formulation, presentation, batch number, expiry date,
manufacturer, purchaser or seller, quantity of the drug purchased or
sold, date of purchase or sale, and other information specified by the
administrative department for veterinary medicine of the State Council.
Article 29 A veterinary drug
distributor shall establish a system for preservation of veterinary
drugs and take all necessary measures including cold storage, protection
against freeze and humidity, and avoidance of insects and rodents, in
order to preserve the quality of veterinary drugs it distributes.
An inspection and acceptance system shall be
implemented for placing veterinary drugs in and releasing them from the
storehouse, and accurate records shall be kept in this regard.
Article 30 Veterinary biologics needed
for compulsory vaccination shall be distributed in compliance with the
provisions laid down by the administrative department for veterinary
medicine of the State Council.
Article 31 The content of an
advertisement for a veterinary drug shall be consistent with that of the
package leaflet. Where such an advertisement is to be published in the
principal national media, the matter shall be subject to examination and
approval by the administrative department for veterinary medicine of
the State Council, and an approval number shall be obtained for the
advertisement of the drug. Where the advertisement of a veterinary drug
is to be published in the local media, the matter shall be subject to
examination and approval by the administrative department for veterinary
medicine of the people’s government of the province, autonomous region
or municipality directly under the Central Government, and an approval
number shall be obtained for the advertisement of the drug; no
advertisement may be published without approval.
Chapter V Import and Export of Veterinary Drugs
Article 32 Where a veterinary drug is
to be exported to China for the first time, the representative office
established by the exporter within the territory of China or the agency
within the territory of China authorized by it shall apply to the
administrative department for veterinary medicine of the State Council
for registration, and submit the following data and articles:
(1) the document certifying that the
veterinary drug regulatory department of the country (region) where the
manufacturer is located has approved the production or marketing of such
drug;
(2) the document issued by the veterinary drug
regulatory department of the country (region) where the manufacturer is
located, certifying that the drug conforms to the Good Manufacturing
Practice for Veterinary Drugs;
(3) the method and process of manufacturing,
quality standards, analytical method, results of pharmacological and
toxicological tests, clinical trial report, stability test report, and
other data relevant to the veterinary drug; the data relating to the
withdrawal period, maximum residue limits, residue analytical method and
their basis for a veterinary drug used for food animals;
(4) a sample copy of the label and package leaflet of the veterinary drug;
(5) a sample, reference substance and standard substance of the veterinary drug;
(6) the environmental impact report and measures for prevention and control of pollution; and
(7) other data concerning safety of the veterinary drug.
Where applying for exporting veterinary biologics to China,
the applicant shall, in addition, provide the master seed bacteria
(viruses or insects), cell lines and other relevant materials and data.
Article 33 The administrative
department for veterinary medicine of the State Council shall arrange
for preliminary examination within 10 working days from the date it
receives the application. If the application passes the preliminary
examination, the said department shall send the data of the veterinary
drug, which it decides to accept, to the veterinary drug evaluation
institution established by itself for evaluation, send the sample of the
drug to the test institution designated by itself for quality retrial,
and shall complete the examination within 60 working days from the date
it receives the results of evaluation and quality retrial. If the drug
passes the examination, the department shall issue a Registration
Certificate of Imported Veterinary Drugs and publish the quality
standards of the drug; if the drug fails to pass the examination, the
department shall notify the applicant thereof in writing.
In the course of examination, the
administrative department for veterinary medicine of the State Council
may carry out an on-the-spot inspection to see whether the enterprise
that intends to export a veterinary drug to China meets the requirements
of the Good Manufacturing Practice for Veterinary Drugs, and shall have
the right to require the enterprise to conduct tests on safety and
efficacy of the drug at an institution designated by the administrative
department for veterinary medicine of the State Council.
As for the importation of a veterinary drug
urgently needed by a domestic user, a small amount of a veterinary drug
to be used for scientific research, or the sample, reference substance
or standard substance of a registered veterinary drug, the matter shall
be handled in accordance with the provisions laid down by the
administrative department for veterinary medicine of the State Council.
Article 34 A Registration
Certificate of Imported Veterinary Drugs is valid for five years. An
exporter that needs to continue the exportation of veterinary drugs to China
after the expiry date shall, six months before the expiry date, apply
to the original department that issued the certificate for renewed
registration.
Article 35 No enterprises from abroad may directly sell veterinary drugs in China. An enterprise from abroad that intends to sell veterinary drugs in China shall, in accordance with the law, establish a sales office within the territory of China or authorize an agency within the territory of China that meets the requirements.
To import a veterinary biologic that has
obtained the Registration Certificate of Imported Veterinary Drugs in
China, the agency within the territory of China shall apply to the
administrative department for veterinary medicine of the State Council
for an import permission certificate for veterinary biologics, and
shall, on the basis of the import permission certificate, complete the
formalities for obtaining a veterinary drug import note from the
administrative department for veterinary medicine of the people’s
government in the place where the port of entry is located; to import
other veterinary drugs that have obtained the Registration Certificate
of Imported Veterinary Drugs in China, the agency shall, on the basis of
the Registration Certificate of Imported Veterinary Drugs, complete the
formalities for obtaining the veterinary drug import note from the
administrative department for veterinary medicine of the people’s
government in the place where the port of entry is located. The Customs
shall release the drugs on the basis of the veterinary drug import note.
The measures for administration of importation of veterinary drugs
shall be formulated by the administrative department for veterinary
medicine of the State Council jointly with the General Administration of
Customs.
After it is imported, a veterinary biologic
shall undergo verification and sampling tests in accordance with the
provisions of Article 19 of these Regulations. After other veterinary
drugs are imported, the local administrative department for veterinary
medicine shall notify the veterinary drug test institution to conduct
sampling tests.
Article 36 Importing any of the following veterinary drugs is prohibited:
(1) drugs with uncertain therapeutic efficacy
or serious adverse reactions, or drugs that may be harmful to the
breeding industry or to human health or harbour potential risks;
(2) veterinary biologics that come from an epidemic area and may cause the spread of the epidemic disease within the territory of China;
(3) drugs manufactured in conditions where an on-the-spot inspection proves to be not in conformity with the provisions; or
(4) drugs the production, distribution or use
of which is prohibited by the administrative department for veterinary
medicine of the State Council.
Article 37 Where a veterinary drug is
to be exported abroad and the importer requires the provision of a
document certifying exportation of the veterinary drug, the
administrative department for veterinary medicine of the State Council
or the administrative department for veterinary medicine of the people’s
government of the province, autonomous region or municipality directly
under the Central Government where the exporter is located may issue
such a document.
The administrative department for veterinary
medicine of the State Council may restrict or prohibit the exportation
of the vaccines that are urgently needed for epidemic prevention within
the country.
Chapter VI Use of Veterinary Drugs
Article 38 Any unit using veterinary
drugs shall comply with the provisions on the safe use of veterinary
drugs laid down by the administrative department for veterinary medicine
of the State Council and keep a record of the use of such drugs.
Article 39 It is prohibited to use
counterfeit and substandard veterinary drugs, as well as drugs and other
compounds the use of which is prohibited according to the provisions of
the administrative department for veterinary medicine of the State
Council. The catalogue of the drugs and other compounds the use of which
is prohibited shall be compiled and published by the administrative
department for veterinary medicine of the State Council.
Article 40 Where a veterinary drug
requiring a withdrawal period is used in food animals, the raiser of the
animals shall provide the purchaser or slaughter with an accurate and
truthful record of use of the drug; the purchaser or slaughter shall
ensure that during the period of drug taking or withdrawal the animals
and their products are not used as food for human consumption.
Article 41 The administrative
department for veterinary medicine of the State Council shall be
responsible for compiling and publishing a catalogue of the varieties of
medicated feed additives permitted to be added in animal feed.
It is prohibited to add in animal feed or
drinking water any hormonal drug or other prohibited drugs specified by
the administrative department for veterinary medicine of the State
Council.
No veterinary drugs that may be added in
animal feed with approval may be added therein before being made into
medicated feed additives by a veterinary drug manufacturer. Directly
adding a bulk drug in animal feed or drinking water or directly
administering such a drug to animals is prohibited.
Using drugs for human beings to animals is prohibited.
Article 42 The administrative
department for veterinary medicine of the State Council shall formulate
and arrange for the implementation of national programmes for monitoring
the residue of veterinary drugs in animals and their products.
The administrative department for veterinary
medicine of the people’s government at or above the county level shall
be responsible for the detection of the residual amount of veterinary
drugs in animal products. The results of the detected residue of
veterinary drugs shall be published by the administrative department for
veterinary medicine of the State Council or the administrative
department for veterinary medicine of the people’s government of the
province, autonomous region or municipality directly under the Central
Government within their respective limits of power.
Any producer or seller of animal products that
objects to the detection results may, within seven working days from
the date it receives the results, submit an application to the
administrative department for veterinary medicine that arranges for the
detection of the residue of veterinary drugs or the administrative
department for veterinary medicine at the next higher level, and the
administrative department for veterinary medicine that accepts the
application shall designate a test institution for a retest.
The residue limits and the residue analytical
methods of veterinary drugs shall be formulated and published by the
administrative department for veterinary medicine of the State Council.
Article 43 It is prohibited to sell
food animal products that contain illicit drugs or in which the residual
amount of veterinary drugs exceeds the limits.
Chapter VII Supervision and Administration of Veterinary Drugs
Article 44 The administrative
department for veterinary medicine of the people’s government at or
above the county level shall exercise the power of supervision and
administration of veterinary drugs.
Testing of veterinary drugs shall be conducted
by the veterinary drug test institutions established by the
administrative department for veterinary medicine of the State Council
or by the administrative department for veterinary medicine of the
people’s government of the province, autonomous region or municipality
directly under the Central Government. The administrative department for
veterinary medicine of the State Council may, when necessary, accredit
other test institutions to conduct testing of veterinary drugs.
Any party that objects to the testing result
of a veterinary drug may, within seven working days from the date it
receives the testing result, apply for a retest to the institution that
did the testing or a test institution established by the administrative
department for veterinary medicine at a higher level.
Article 45 Veterinary drugs shall measure up to the national standards of such drugs.
The Chinese Veterinary Pharmacopoeia drafted
by the National Veterinary Pharmacopoeia Commission and promulgated by
the administrative department for veterinary medicine of the State
Council, and other quality standards of veterinary drugs issued by the
administrative department for veterinary medicine of the State Council
constitute the national standards of veterinary drugs.
The standardization of standard and reference
substances for the national standards of veterinary drugs shall be the
responsibility of the veterinary drug test institution established by
the administrative department for veterinary medicine of the State
Council.
Article 46 When carrying out
supervision and inspection in accordance with the law, the
administrative department for veterinary medicine shall take compulsory
administrative measures to seal up or distrain the veterinary drugs that
are proved to be potentially counterfeit or substandard and shall,
within seven working days from the date it takes the compulsory
administrative measures, decide on whether or not to place the case on
file; where test is needed, it shall, within 15 working days from the
date the test report is issued, decide on whether or not to place the
case on file; where the conditions for placing the case on file are not
satisfied, it shall discontinue the compulsory administrative measures;
where the manufacturing, distribution or use of the drug needs to be
suspended, the administrative department for veterinary medicine of the
State Council or the administrative department for veterinary medicine
of the people’s government of the province, autonomous region or
municipality directly under the Central Government shall make a decision
thereon within their respective limits of power.
Without approval by the department that makes
the decision on taking compulsory administrative measures or the
department at the next higher level, no veterinary drugs or relevant
materials that are sealed up or distrained may be transferred, used,
destroyed or sold.
Article 47 A veterinary drug is a counterfeit one in any of the following cases:
(1) a non-veterinary drug substance is passed off as a veterinary drug or one veterinary drug is passed off as another; or
(2) the types or names of the ingredients
contained in a veterinary drug are not in conformity with the national
standards of veterinary drugs.
A veterinary drug shall be treated as counterfeit in any of the following cases:
(1) its use is prohibited according to the
provisions of the administrative department for veterinary medicine of
the State Council;
(2) it is manufactured or imported without
examination and approval as is required by these Regulations, or it is
marketed or imported without sampling tests or verification as is
required by these Regulations;
(3) it is deteriorated;
(4) it is contaminated; or
(5) the indications or functions indicated are beyond the specified scope.
Article 48 A veterinary drug is a substandard one in any of the following cases:
(1) the content of the ingredients is not up
to the national standards of veterinary drugs, or the active ingredients
are not indicated;
(2) the expiry date is not indicated or is altered, or the drug is beyond the expiry date;
(3) the batch number is not indicated or is altered; or
(4) other veterinary drugs that are not up to the national standards of veterinary drugs but are not counterfeit.
Article 49 It is prohibited to sell a
bulk veterinary drug piecemeal or sell such a drug to other units or
individuals than veterinary drug manufacturers.
It is prohibited to sell, purchase or use,
without the prescription of a veterinarian, any veterinary drugs
specified as prescription drugs by the administrative department for
veterinary medicine of the State Council.
Article 50 The State practises a report system for adverse reactions of veterinary drugs.
When discovering serious adverse reactions
that are possibly induced by the use of a veterinary drug, the
veterinary drug manufacturer, distributor or user, or the veterinarian
who prescribes the drug shall promptly report the matter to the
administrative department for veterinary medicine of the local people’s
government.
Article 51 Where a veterinary drug
manufacturer or distributor has suspended production or distribution for
at least six months or is closed down, the original department that
issued the licence shall order it to return the Veterinary Drug
Manufacturing Licence or the Veterinary Drug Distribution Licence, and
the administrative department for industry and commerce shall change or
cancel its business registration.
Article 52 Trading in, renting out or
lending the Veterinary Drug Manufacturing Licence, Veterinary Drug
Distribution Licence or veterinary drug approval documents is
prohibited.
Article 53 The items and rates of fees
charged for evaluation and testing of veterinary drugs shall be decided
on and published by the finance department of the State Council jointly
with the competent pricing department of the State Council.
Article 54 No administrative
departments for veterinary medicine or veterinary drug test institutions
at various levels, nor their staff members may be involved in the
manufacturing or distribution of veterinary drugs, nor may they
recommend veterinary drugs in their names or have the supervisors for
drug manufacturing or sale named after them.
Chapter VIII Legal Liability
Article 55 Any administrative
department for veterinary medicine or any of its staff members that,
taking advantage of its position, accepts another person’s money or
things of value or seeks other benefits, issues licences or, after
examination, grants approval with its signature to the unit or
individual that does not meet the statutory requirements, fails to
fulfill its duties of supervision, or fails to investigate and punish
violations of law it discovers, which causes serious consequences and
constitutes a crime, shall be investigated for criminal liability in
accordance with the law; if no crime is constituted, it shall be given
administrative sanctions in accordance with the law.
Article 56 In violation of the
provisions of these Regulations, any entity that produces or distributes
veterinary drugs without a Veterinary Drug Manufacturing Licence or
Veterinary Drug Distribution Licence, or produces or distributes
counterfeit or substandard veterinary drugs even if it has a Veterinary
Drug Manufacturing Licence or Veterinary Drug Distribution Licence, or
any veterinary drug distributor that distributes drugs for human use,
shall be ordered to desist from producing or distributing the drugs, the
drug substances, excipients and packaging materials used for illegal
production, as well as the veterinary drugs produced or distributed and
the unlawful gains therefrom shall be confiscated and, in addition, a
fine of not less than two times but not more than five times the value
of the veterinary drugs illegally produced or distributed (including the
veterinary drugs sold and not sold, the same below) shall be imposed;
if the amount of the value cannot be investigated and verified, a fine
of not less than 100,000 yuan but not more than 200,000 yuan shall be
imposed; if veterinary drugs are produced without a Veterinary Drug
Manufacturing Licence and the circumstances are serious, the
manufacturing equipment shall be confiscated; if counterfeit or
substandard veterinary drugs are produced or distributed and the
circumstances are serious, its Veterinary Drug Manufacturing Licence or
Veterinary Drug Distribution Licence shall be revoked; if a crime is
constituted, criminal liability shall be investigated in accordance with
the law; if losses are caused to another person, the liability for
compensation shall be borne in accordance with the law. The principal
leading members of the manufacturer or distributor and the persons in
charge who are directly responsible shall not be allowed to engage in
production or distribution of veterinary drugs for their lifetime.
Manufacturing, without approval, of veterinary
biologics needed for compulsory vaccination shall be punished the same
as for manufacturing of veterinary drugs without a Veterinary Drug
Manufacturing Licence.
Article 57 Where an entity, in
violation of the provisions of these Regulations, obtains the Veterinary
Drug Manufacturing Licence, the Veterinary Drug Distribution Licence,
or veterinary drug approval document by providing false data, samples or
by other fraudulent means, its Veterinary Drug Manufacturing Licence or
Veterinary Drug Distribution Licence shall be revoked, or the
veterinary drug approval document shall be withdrawn and, in addition, a
fine of not less than 50,000 yuan but not more than 100,000 yuan shall
be imposed; if losses are caused to another person, the liability for
compensation shall be borne in accordance with the law. The principal
leading members of the entity and the persons in charge who are directly
responsible shall not be allowed to engage in production, distribution,
or importation and exportation of veterinary drugs for their lifetime.
Article 58 Where an entity trades in,
rents out or lends the Veterinary Drug Manufacturing Licence, Veterinary
Drug Distribution Licence or veterinary drug approval document, its
unlawful gains therefrom shall be confiscated and, in addition, a fine
of not less than 10,000 yuan but not more than 100,000 yuan shall be
imposed; if the circumstances are serious, its Veterinary Drug
Manufacturing Licence or Veterinary Drug Distribution Licence shall be
revoked, or the veterinary drug approval document shall be withdrawn; if
a crime is constituted, criminal liability shall be investigated in
accordance with the law; if losses are caused to another person, the
liability for compensation shall be borne in accordance with the law.
Article 59 Any institution for
veterinary drug safety evaluation or clinical trial or any manufacturer
or distributor that, in violation of the provisions of these
Regulations, fails to implement the Good Laboratory Practice, Good
Clinical Practice, Good Manufacturing Practice or Good Sale Practice for
Veterinary Drugs in accordance with the provisions shall be given a
warning and shall be ordered to rectify within a time limit; if it fails
to comply at the expiration of the time limit, it shall be ordered to
desist from research and trial, production, or distribution of
veterinary drugs and shall, in addition, be fined not more than 50,000
yuan; if the circumstances are serious, its Veterinary Drug
Manufacturing Licence or Veterinary Drug Distribution Licence shall be
revoked; if losses are caused to another person, it shall bear the
liability for compensation in accordance with the law.
Any entity that, in violation of the
provisions of these Regulations, uses pathogenic microorganisms of Class
I in the research and development of a new veterinary drug with no
conditions required, or does so with no approval obtained prior to the
laboratory stage shall be ordered to desist from the experimentation and
shall, in addition, be fined not less than 50,000 yuan but not more
than 100,000 yuan; if a crime is constituted, it shall be investigated
for criminal liability in accordance with the law; if losses are caused
to another person, it shall bear the liability for compensation in
accordance with the law.
Article 60 Any entity that, in
violation of the provisions of these Regulations, fails to have the
label and package leaflet of a veterinary drug approved shall be ordered
to rectify within a time limit; if it fails to comply at the expiration
of the time limit, it shall be punished the same as for the
manufacturing or distribution of counterfeit veterinary drugs; the
approval number of the veterinary drug product, if any, shall be
cancelled; if losses are caused to another person, the liability for
compensation shall be borne in accordance with the law.
Where no label and package leaflet are
attached to the package of a veterinary drug or the label and package
leaflet are different from what is approved in content, an order shall
be given to rectify the situation within a time limit; if the
circumstances are serious, a penalty shall be imposed in accordance with
the provisions of the preceding paragraph.
Article 61 Any enterprise from abroad
that, in violation of the provisions of these Regulations, directly
sells veterinary drugs in China shall be ordered to rectify within a
time limit, the veterinary drugs for direct sale and its unlawful gains
shall be confiscated and, in addition, a fine of not less than 50,000
yuan but not more than 100,000 yuan shall be imposed; if the
circumstances are serious, its Registration Certificate of Imported
Veterinary Drugs shall be revoked; if losses are caused to another
person, the liability for compensation shall be borne in accordance with
the law.
Article 62 Any entity that, in
violation of the provisions of these Regulations, fails to use
veterinary drugs in accordance with the provisions of the State on the
safe use of veterinary drugs, or fails to keep a record of the use of
the drugs or keeps an incomplete or untruthful record, or uses the drugs
or other compounds the use of which is prohibited, or uses drugs for
human use in animals, shall be ordered to rectify promptly and to give
innocuous treatment to the animals that are administered with the
illicit drugs or other compounds as well as to their products; the unit
violating the provisions shall be fined not less than 10,000 yuan but
not more than 50,000 yuan; if losses are caused to another person, the
liability for compensation shall be borne in accordance with the law.
Article 63 Any entity that, in
violation of the provisions of these Regulations, sells animals being in
the period of drug taking or withdrawal or their products as food for
human consumption, or sells animal products, which contain any illicit
drug or in which the residual amount of a veterinary drug exceeds the
limits, as food for human consumption, shall be ordered to give
innocuous treatment to the said animal products, its unlawful gains
shall be confiscated and, in addition, a fine of not less than 30,000
yuan but not more than 100,000 yuan shall be imposed; if a crime is
constituted, criminal liability shall be investigated in accordance with
the law; if losses are caused to another person, the liability for
compensation shall be borne in accordance with the law.
Article 64 Any entity that, in
violation of the provisions of these Regulations, transfers, uses,
destroys or sells without approval the veterinary drugs or relevant
materials which are sealed up or distrained shall be ordered to desist
from the violation, shall be given a warning and shall, in addition, be
fined not less than 50,000 yuan but not more than 100,000 yuan.
Article 65 Any veterinary drug
manufacturer, distributor or user, or veterinarian who prescribes drugs
that discovers serious adverse reactions that are possibly induced by
the use of a veterinary drug but, in violation of the provisions of
these Regulations, fails to report the matter to the administrative
department for veterinary medicine of the local people’s government,
shall be given a warning and shall, in addition, be fined not less than
5,000 yuan but not more than 10,000 yuan.
Any manufacturer that, during the period of
surveillance of a new veterinary drug, fails to collect or to promptly
submit the data concerning the therapeutic efficacy and adverse
reactions of the drug shall be ordered to rectify within a time limit
and shall, in addition, be fined not less than 10,000 yuan but not more
than 50,000 yuan; if the circumstances are serious, the approval number
of the product for the drug shall be revoked.
Article 66 Any entity that, in
violation of the provisions of these Regulations, sells, purchases or
uses veterinary prescription drugs without the prescription of a
veterinarian shall be ordered to rectify within a time limit, its
unlawful gains shall be confiscated and, in addition, a fine of not more
than 50,000 yuan shall be imposed; if losses are caused to another
person, the liability for compensation shall be borne in accordance with
the law.
Article 67 In violation of the
provisions of these Regulations, any veterinary drug manufacturer or
distributor that sells a bulk veterinary drug to other units or
individuals than veterinary drug manufacturers, or any veterinary drug
distributor that sells such a drug piecemeal, shall be ordered to
rectify promptly and shall be given a warning, its unlawful gains shall
be confiscated and, in addition, a fine of not less than 20,000 yuan but
not more than 50,000 yuan shall be imposed; if the circumstances are
serious, its Veterinary Drug Manufacturing Licence or Veterinary Drug
Distribution Licence shall be revoked; if losses are caused to another
person, the liability for compensation shall be borne in accordance with
the law.
Article 68 Any entity that, in
violation of the provisions of these Regulations, adds in animal feed or
drinking water any hormonal drug or other prohibited drugs specified by
the administrative department for veterinary medicine of the State
Council shall be punished in accordance with the relevant provisions of
the Regulations on Administration of Animal Feed and Feed Additives; any
entity that directly adds a bulk drug in animal feed or drinking water
or administers such a drug to animals shall be ordered to rectify
promptly and shall, in addition, be fined not less than 10,000 yuan but
not more than 30,000 yuan; if losses are caused to another person, the
liability for compensation shall be borne in accordance with the law.
Article 69 In any of the following
cases the approval number of a product for a veterinary drug shall be
cancelled or the Registration Certificate of Imported Veterinary Drugs
be revoked:
(1) the drug fails to pass two consecutive sampling tests;
(2) the therapeutic efficacy of the drug is
uncertain, its adverse reactions are serious, it may be harmful to the
breeding industry or to human health, or it harbours potential risks; or
(3) the production, distribution or use of the
drug is prohibited by the administrative department for veterinary
medicine of the State Council.
Where their approval numbers of the products
are cancelled or Registration Certificates of Imported Veterinary Drugs
are revoked, the veterinary drugs shall not be produced, imported,
distributed or used any longer. Such drugs already produced or imported
shall be destroyed under the supervision of the local administrative
department for veterinary medicine, and the expenses thus entailed shall
be paid by the violator; if losses are caused to another person, the
liability for compensation shall be borne in accordance with the law.
Article 70 The administrative
penalties provided for by these Regulations shall be decided on by the
administrative department for veterinary medicine of the people’s
government at or above the county level; among such penalties, the
decision on revocation of the Veterinary Drug Manufacturing Licence or
Veterinary Drug Distribution Licence, on withdrawal of the veterinary
drug approval document or on an order for desisting from the research
and trial of veterinary drugs shall be made by the original department
that issues the licence or document or the approval department.
The administrative department for veterinary
medicine at a higher level shall order the one at a lower level that
performs administrative acts in violation of these Regulations to
rectify within a time limit; if the latter does not comply at the
expiration of the time limit, the former shall have the power to alter
or annul such acts.
Article 71 The value of a veterinary
drug mentioned in these Regulations shall be calculated on the basis of
the marked price of the veterinary drug illegally produced or
distributed; if there is no price marked, it shall be calculated on the
basis of the market price of the veterinary drug of the same kind.
Chapter IX Supplementary Provisions
Article 72 The meanings of the following terms used in these Regulations are:
(1) “Veterinary drugs” means substances
(including medicated feed additives) used for prevention, treatment and
diagnosis of animal diseases, or intended for regulation of the
physiological functions of animals, mainly including sera, vaccines,
diagnostic kits, probiotics, crude Chinese medicines, traditional
Chinese medicine preparations, chemical pharmaceuticals, antibiotics,
biochemical drugs, radioactive pharmaceuticals, ectoparasiticides and
disinfectants.
(2) “Veterinary prescription drugs” means veterinary drugs purchased and used only by the prescription of a veterinarian.
(3) “Veterinary non-prescription drugs” means
veterinary drugs that are published as such by the administrative
department for veterinary medicine of the State Council and can be
freely purchased without the prescription of a veterinarian and used in
accordance with the package leaflet.
(4) “Veterinary drug manufacturers” means
enterprises exclusively or partly engaged in production of veterinary
drugs, including the ones engaged in repacking of veterinary drugs.
(5) “Veterinary drug distributors” means enterprises exclusively or partly engaged in distribution of veterinary drugs.
(6) “New veterinary drugs” means veterinary drugs that have not yet been placed on the market within the territory of China.
(7) “Veterinary drug approval documents”
includes the documents such as the approval number of a veterinary drug
product, the Registration Certificate of Imported Veterinary Drugs, the
import permission certificate for veterinary biologics, the document
certifying exportation of a veterinary drug, and the Registration
Certificate of New Veterinary Drugs.
Article 73 Special drugs including
narcotic drugs, psychotropic substances, toxic drugs and radioactive
pharmaceuticals used for animals shall be administered in accordance
with the relevant provisions of the State.
Article 74 The use, detection of
residues, supervision and administration of veterinary drugs in
aquaculture, and the imposition of administrative penalties for unlawful
use of drugs in the course of breeding aquatics shall be the
responsibility of the competent department for fisheries of the people’s
government at or above the county level and the fisheries authorities
affiliated to the department.
Article 75 These Regulations shall be effective as of November 1, 2004.
|
Tuesday, January 28, 2014
Food Hygiene Law of the People’s Republic of China
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