Full Text of the Implementation Rules of Yunnan Province for the Quality Management Standards of Veterinary Drug Business

Chapter 1 General Provisions
Article 1 These Rules are formulated in accordance with the Regulations on the Administration of Veterinary Drugs and the Good Supply Practice for Veterinary Drugs of the Ministry of Agriculture in order to strengthen the quality management of veterinary drug business and ensure the quality of veterinary drugs.
Article 2 These Rules apply to veterinary drug trading enterprises within the territory of Yunnan Province.
Chapter 2 Premises and Facilities
Article 3 A veterinary drug trading enterprise shall have fixed business premises and warehouses. The business premises and warehouses shall be reasonably laid out and relatively independent.
The area, facilities and equipment of the business premises shall be commensurate with the varieties of veterinary drugs handled and the scale of business. The business premises area of a veterinary drug trading enterprise located in a county seat shall not be less than 30 sq m; the business premises area of a veterinary drug trading enterprise in a township or below shall not be less than 20 sq m. The veterinary drug business area shall be set up independently from the living area and the animal diagnosis and treatment area to avoid cross-contamination. An enterprise engaged in animal diagnosis and treatment activities that also deals in veterinary drugs shall have an independent veterinary drug business activity area.
Article 4 The business location of a veterinary drug trading enterprise shall be consistent with the location stated in the Veterinary Drug Business License. The Veterinary Drug Business License shall be hung in a prominent position on the business premises.
If the business location is changed, an application shall be made to renew the veterinary drug business license.
If the area of the business premises is changed, it shall be filed with the issuing authority within 30 working days after the change.
Article 5 A veterinary drug trading enterprise shall have warehouses such as ordinary-temperature warehouses, cool warehouses (cabinets), cold storage warehouses (cabinets) and related facilities and equipment that are commensurate with the varieties of veterinary drugs handled and the scale of business and that can ensure the quality of veterinary drugs. Small veterinary drug trading enterprises established in township areas and veterinary drug trading enterprises specializing in pet diagnosis and treatment activities may, according to the storage conditions of the veterinary drug varieties handled, set up only a cool warehouse.
A veterinary drug trading enterprise dealing in large quantities of solid disinfectants shall set up an independent dedicated warehouse for solid disinfectants, whose area shall be commensurate with the varieties and scale of the solid disinfectants handled, and shall be equipped with corresponding fire-fighting facilities.
The warehouse area of a veterinary drug trading enterprise located in a county seat shall not be less than 50 sq m; the warehouse area of a veterinary drug trading enterprise located in a township shall not be less than 20 sq m. Its related facilities and equipment shall meet the requirements for the division of different areas such as the qualified veterinary drug area, the unqualified veterinary drug area, the veterinary drug area pending inspection and the returned veterinary drug area, and for the partitioned and classified storage and preservation of different veterinary drug varieties, and shall ensure sufficient operating space to minimize errors and cross-contamination. Each type of area and each type of variety shall be provided with clear signs.
If the warehouse location is changed, or the number or area of warehouses and related facilities and equipment are increased or decreased, it shall be filed with the issuing authority within 30 working days after the change.
Article 6 For a directly operated chain veterinary drug trading enterprise with uniformly configured warehousing within the same county (city), each chain store shall, according to the needs of the varieties handled and the scale, set up ordinary-temperature warehouses, cool warehouses, etc. of a certain area for the temporary storage of veterinary drugs for retail sale at the store.
Article 7 The shelves, counters and related facilities and equipment of the veterinary drug business premises shall be complete, clean and in good condition, capable of displaying all the veterinary drug varieties handled, and prominent signs shall be set up according to the different varieties, categories and uses of the veterinary drugs handled.
Article 8 The floors, walls and ceilings of the business premises and warehouses of a veterinary drug trading enterprise shall be flat, dry and clean; doors, windows and other structures shall be tightly constructed, lockable and easy to clean.
Article 9 The veterinary drug business premises shall have the following facilities and equipment:
(1) Display shelves and counters suitable for the veterinary drug varieties handled; the area occupied by the shelves and counters shall reach more than one third of the area of the business premises;
(2) The veterinary drug business premises shall have ventilation, fire-fighting and lighting facilities and equipment;
(3) If any of the veterinary drugs handled require light-protected and temperature-controlled display, there shall be control facilities, equipment and monitoring instruments for temperature, humidity, light and other conditions that meet the requirements for veterinary drug display conditions;
(4) Facilities and equipment for dust prevention, moisture prevention, mildew prevention, pollution prevention, and insect, rodent and bird prevention;
(5) Facilities and equipment for environmental and personnel hygiene and cleaning, etc.;
(6) A veterinary drug quality information bulletin board shall be set up in a prominent position on the business premises, posting veterinary drug management regulations, personnel duties and division of work, clearly stating the service convention, quality commitment and service supervision telephone number, and setting up a suggestion book.
Article 10 The veterinary drug storage warehouse shall have the following facilities and equipment:
(1) Moisture-proof partitions or shelves for veterinary drugs shall be set up, and the moisture-proof partitions shall be kept at a distance of 10 cm from the ground;
(2) Facilities and equipment for insect prevention, rodent prevention, bird prevention, fire prevention, ventilation and lighting, etc.;
(3) Isolation facilities to prevent confusion and contamination between different varieties and batches of veterinary drugs;
(4) Tools and equipment for unpacking and packing veterinary drugs;
(5) For veterinary drugs with special requirements such as light protection and temperature control, corresponding control facilities, equipment and monitoring instruments shall be provided;
Article 11 A veterinary biological products trading enterprise shall have storage and transportation facilities and equipment commensurate with the scale of business:
(1) At least 1 independent cold storage warehouse, with a volume of not less than 20 cubic meters; and equipped with 3—5 cubic meter refrigerated cabinets and more than 3 refrigerators of 200 liters;
(2) Vaccine transportation shall have necessary heat preservation or refrigeration measures and shall meet the temperature and other environmental condition requirements needed for the transportation of veterinary biological products.
Article 12 The facilities and equipment used for the storage of veterinary biological products shall meet the following conditions:
(1) Cold storage warehouses (cabinets) shall be installed with dual power supply lines or have backup generator sets;
(2) The temperature of cold storage warehouses shall meet the storage requirements of vaccines, among which the temperature of ordinary cold storage warehouses (cabinets) is 2-8°C; the temperature of low-temperature cold storage warehouses (cabinets) is below -15°C. For the handling of products with special requirements, their storage conditions shall comply with the product instructions.
(3) Cold storage warehouses shall have devices for automatic temperature monitoring, regulation, recording and alarming.
Article 13 The floor, walls and ceiling in the cold storage warehouse shall be smooth and flat, and there shall be equipment and measures to maintain appropriate spacing or isolation between vaccines and the floor, walls, ceiling and condensers.
Article 14 There shall be lighting facilities in the cold storage warehouse that meet safe electricity use requirements.
Article 15 The cold storage warehouse shall be divided into dedicated areas such as the pending inspection area, the qualified product area, the dispatch area and the return area. Each of the above areas shall be provided with clear signs and shall be managed by color coding.
Article 16 There shall be suitable workplaces in the cold storage warehouse for breaking bulk and consolidated shipment dispatch.
Article 17 The vaccine receiving premises shall meet the requirements for vaccine storage.
Article 18 Those dealing in Chinese medicinal materials and Chinese medicinal decoction pieces shall set up a traditional Chinese medicine specimen room (cabinet).
Article 19 Those dealing in special drugs such as veterinary psychotropic drugs, toxic drugs, narcotic drugs, radioactive drugs and precursor chemicals shall comply with the relevant state provisions. At the same time, they shall have an independent warehouse, or an isolated warehouse, or an independent storage cabinet, as well as safety facilities and equipment complying with relevant provisions; establish a special safety custody and prevention system, adopt effective safety custody and prevention measures, and implement a two-person dual-lock custody system.
Article 20 A veterinary drug trading enterprise shall regularly carry out effective inspection, repair and maintenance of the facilities and equipment used.
Chapter 3 Organization and Personnel
Article 21 A veterinary drug trading enterprise shall set up fixed and reasonable organizational bodies or personnel for veterinary drug procurement, storage, sales and quality management, and shall clarify the duties of each body and personnel.
The person directly in charge of a veterinary drug trading enterprise shall be familiar with the laws, regulations and policy provisions on veterinary drug management, possess corresponding professional knowledge of veterinary drugs, and shall accept training and assessment organized by the veterinary administrative department at or above the county level and take up the post with a certificate.
Article 22 A veterinary drug trading enterprise shall be equipped with quality management personnel suitable for the veterinary drugs handled. Where conditions permit, a quality management body may be established. The duties of the quality management body are:
(1) To implement the Regulations on the Administration of Veterinary Drugs and other relevant laws, regulations and administrative rules on veterinary drug management;
(2) To draft the enterprise's veterinary drug quality management system and guide and supervise its implementation;
(3) To be responsible for the quality review of suppliers and relevant veterinary drug varieties;
(4) To be responsible for establishing quality files for the veterinary drugs handled by the enterprise;
(5) To be responsible for inquiries about veterinary drug quality, and the investigation, handling and reporting of veterinary drug quality accidents or quality complaints;
(6) To be responsible for the acceptance inspection of veterinary drugs, and to guide and supervise the quality work in the storage and transportation of veterinary drugs;
(7) To be responsible for the review of unqualified veterinary drugs and to supervise the handling process of unqualified veterinary drugs;
(8) To collect and analyze veterinary drug quality information;
(9) To assist in carrying out education or training for enterprise employees on veterinary drug quality management;
(10) Other related work.
If a small retail enterprise has not set up a quality management body because of its small scale of business, it shall set up quality management personnel, whose work shall be carried out according to the functions of the above quality management body.
An enterprise dealing in veterinary biological products must establish a quality management body and be equipped with no fewer than 2 quality management personnel.
Article 23 The person in charge of quality of a veterinary drug trading enterprise and the person in charge of the quality management body shall have a college degree or above in veterinary drugs, veterinary medicine or other related majors, or an intermediate or above professional technical title in veterinary drugs, veterinary medicine or other related majors, and be familiar with the laws, regulations and policy provisions on veterinary drug management. For small veterinary drug trading enterprises established in township areas, the person in charge of quality and the person in charge of the quality management body (if set up) shall have a secondary specialized school degree or above in veterinary drugs, veterinary medicine or other related majors, or a junior or above professional technical title in veterinary drugs, veterinary medicine or other related majors. The person in charge of quality and the person in charge of the quality management body shall accept training and assessment organized by the veterinary administrative department at or above the county level and take up the post with a certificate.
Veterinary drug quality management personnel shall have a secondary specialized school degree or above in veterinary drugs, veterinary medicine or other related majors, or a junior or above professional technical title in veterinary drugs, veterinary medicine or other related majors, and shall accept training and assessment organized by the veterinary administrative department at or above the county level and take up the post with a certificate. For those dealing in veterinary biological products, the veterinary drug quality management personnel shall have a college degree or above in veterinary drugs, veterinary medicine or other related majors, or an intermediate or above professional technical title in veterinary drugs, veterinary medicine or other related majors, and shall possess professional knowledge in the production, transportation, preservation, quality testing and use of veterinary biological products.
When the person in charge of quality, the person in charge of the quality management department or the quality management personnel is changed, it shall be filed with the issuing authority within 30 working days after the change.
Article 24 The personnel of a veterinary drug trading enterprise engaged in veterinary drug procurement, storage, sales and technical services shall include at least 1 person with a high school education or above, and shall possess corresponding professional knowledge of veterinary drugs, veterinary medicine, etc., and be familiar with the laws, regulations and policy provisions on veterinary drug management.
Article 25 The personnel of a veterinary drug trading enterprise responsible for issuing prescriptions shall have a college degree or above in veterinary medicine, animal husbandry and veterinary medicine, or traditional Chinese veterinary medicine (ethnic veterinary medicine), or possess an intermediate or above professional technical title of veterinary physician, or have obtained a practicing veterinary physician qualification certificate recognized by the Ministry of Agriculture and the provincial veterinary administrative department, and have the ability to correctly judge and handle clinical medication for animals and the safe use of veterinary drugs.
Article 26 A veterinary drug trading enterprise shall formulate training plans, regularly conduct training and assessment for employees on laws, regulations and policy provisions on veterinary drug management and on professional knowledge such as veterinary drugs and veterinary medicine and professional ethics, and establish training and assessment files.
Chapter 4 Rules and Regulations
Article 27 A veterinary drug trading enterprise shall establish a quality management system, formulate quality management documents such as management systems and operating procedures, form a quality manual, and regularly inspect and assess the implementation.
The quality management documents shall include the following contents:
(1) The enterprise's quality management objectives;
(2) The enterprise's organizational bodies, posts and personnel duties;
(3) The quality assessment system for suppliers and purchased veterinary drugs;
(4) Management systems for the links of veterinary drug procurement, acceptance inspection, warehousing, display, storage, transportation, sales and outbound delivery;
(5) Environmental sanitation management system;
(6) Veterinary drug adverse reaction reporting system;
(7) Management system for unqualified veterinary drugs and returned veterinary drugs;
(8) Management system for quality accidents, quality inquiries and quality complaints;
(9) Management system for enterprise records, files and vouchers;
(10) Quality management training and assessment management system;
Article 28 The quality management records of a veterinary drug trading enterprise shall be true, accurate, complete and clear, and shall not be altered, forged or tampered with at will. If modification is truly necessary, it shall be signed and dated, and the original data shall remain clearly legible. Records shall be signed by the handler or responsible person to ensure the traceability of veterinary drug products and relevant personnel.
The records shall include the following contents:
(1) Personnel training and assessment records;
(2) Records of maintenance, servicing, cleaning and operating status of facilities and equipment for controlling temperature and humidity;
(3) Veterinary drug quality assessment records;
(4) Records of veterinary drug procurement, acceptance inspection, warehousing, storage, sales and outbound delivery;
(5) Veterinary drug inventory checking records;
(6) Records of veterinary drug quality complaints, quality disputes, quality accidents and adverse reactions;
(7) Records of handling unqualified veterinary drugs and returned veterinary drugs;
(8) Records of supervision and inspection by the veterinary administrative department.
Article 29 A veterinary drug trading enterprise shall establish veterinary drug quality management files, set up an archive management room or archive cabinet, and assign a dedicated person to be responsible.
The quality management files shall include:
(1) Personnel files, training files, equipment and facility files, supplier quality assessment files and product quality files;
(2) Issued prescriptions, purchase and sales vouchers, etc.;
(3) Purchase and sales records and other records specified in these Standards.
Quality management files shall not be altered, and the retention period shall not be less than 2 years; purchase and sales records and vouchers shall be retained until one year after the product expiry date.
Chapter 5 Procurement and Warehousing
Article 30 A veterinary drug trading enterprise purchasing veterinary drugs shall follow the procedures below:
(1) Determine the qualifications and quality reputation of the supplier;
(2) Review the legality and quality reliability of the veterinary drugs purchased;
(3) Confirm the legal qualifications of the sales personnel of the supplier conducting business contacts with the enterprise;
(4) For a variety handled for the first time, fill in a veterinary drug variety purchase approval form, and obtain the review and approval of the enterprise's quality management body and the person in charge;
(5) Sign a procurement contract with clear quality clauses;
(6) File with the county-level veterinary administrative department.
Article 31 The review of supplier qualifications shall include the following contents:
(1) Business license;
(2) Veterinary drug production license, veterinary drug GMP certificate (if the supplier is a production enterprise);
(3) Veterinary drug business license (if the supplier is a trading enterprise).
Article 32 The review of the legality and quality of a variety handled for the first time shall include the following contents:
(1) Verify the product approval number of the veterinary drug;
(2) Veterinary drug quality standards and inspection reports;
(3) Review whether the contents of the veterinary drug label and instructions comply with the provisions.
(4) Understand the performance, uses, storage conditions and quality reputation of the veterinary drug;
(5) For imported veterinary drugs, verify the contents such as the imported veterinary drug registration certificate, veterinary biological products import license and imported veterinary drug customs clearance form.
Article 33 When purchasing veterinary drugs, a veterinary drug trading enterprise shall sign a procurement contract with the supplier. The contract contents shall include clauses guaranteeing the quality of veterinary drugs.
A veterinary drug trading enterprise shall keep valid vouchers for the procurement of veterinary drugs and establish true and complete procurement records, so that valid vouchers, accounts and goods are consistent.
The procurement records shall state the generic name, trade name, approval number, batch number, dosage form, specification, expiry date, manufacturer, supplier, purchased quantity, purchase date, handler or responsible person of the veterinary drug, etc.
Article 34 When purchasing veterinary drugs, a veterinary drug trading enterprise must strictly implement the incoming goods inspection and acceptance system, verify the product quality certificate, packaging, label and instructions, establish a product purchase ledger, and request from the supplier, according to the product production batch, a copy of the inspection report issued by an inspection institution meeting statutory conditions; only those meeting the requirements may be purchased.
For the purchase of veterinary biological products, inspection and acceptance shall be carried out by two or more persons.
When necessary, the purchased veterinary drugs shall be inspected or entrusted to a veterinary drug inspection institution for inspection, and the inspection report shall be kept together with the product quality file.
Article 35 Veterinary drugs under any of the following circumstances shall not be put into storage:
(1) Those not assessed or inconsistent with the supplier's quality assessment information;
(2) Those inconsistent with the procurement contract or dispatch note;
(3) Those whose inner or outer packaging is damaged and may affect product quality, those without labels or instructions, or those whose labels or instructions are illegible;
(4) Those whose product approval number, expiry date, etc. have expired;
(5) Those failing quality acceptance inspection;
(6) Other cases not complying with laws and regulations and veterinary drug quality provisions.
Article 36 Veterinary drug inspection shall be carried out in an environment that does not affect the quality of the veterinary drugs.
Chapter 6 Display and Storage
Article 37 Veterinary drug products that pass inspection shall be stored in the warehouse according to the different storage condition requirements of the veterinary drug products, managed by labeling, and a location card shall be established.
After veterinary drug products are put into storage, a certain number of samples of each variety shall, according to the storage condition requirements of the veterinary drug products, be displayed by category and in zones on shelves and counters with suitable conditions on the business premises.
For large-package veterinary drugs, bulk drugs, dangerous drugs, and veterinary drug products with special requirements for ambient temperature, humidity and light, only empty packages, product labels or photographs may be displayed.
Article 38 The display and storage of veterinary drugs shall meet the following requirements:
(1) Stored by variety, category, use and storage requirements such as temperature and humidity, in classified zones or dedicated warehouses;
(2) Handled and stored according to the requirements of the pictorial marks on the outer packaging of veterinary drugs;
(3) The distance from the warehouse floor shall not be less than 10 cm, and the distance between veterinary drugs and walls and the roof shall not be less than 30 cm;
(4) Internal-use veterinary drugs and external-use veterinary drugs shall be stored separately, and veterinary prescription drugs and non-prescription drugs shall be stored separately; veterinary drugs prone to odor transfer, toxic veterinary drugs and specially controlled drugs shall be stored in separate warehouses from other veterinary drugs; veterinary drugs containing flammable, explosive components and strong corrosiveness shall be managed as dangerous goods and stored in separate warehouses from other veterinary drugs, and the storage warehouse shall be relatively independent and isolated;
(5) Veterinary drugs pending inspection, qualified veterinary drugs, unqualified veterinary drugs and returned veterinary drugs shall be stored in separate zones;
(6) Products of the same batch number from the same enterprise shall be stored together.
Article 39 Different areas and different types of veterinary drugs shall have clear identification marks. The marks shall be placed accurately and the writing shall be clear.
Color coding shall be implemented for veterinary drug categories: unqualified veterinary drugs shall be marked in red font; veterinary drugs pending inspection and returned veterinary drugs shall be marked in yellow font; qualified veterinary drugs shall be marked in green font.
Article 40 A veterinary drug trading enterprise shall regularly inspect the veterinary drugs and the conditions of their display and storage and the operating status of facilities and equipment, and keep records.
Article 41 A veterinary drug trading enterprise shall regularly check expired and invalid veterinary drugs, promptly check and remove from shelves counterfeit and inferior veterinary drugs published by the Ministry of Agriculture and the provincial veterinary administrative department, and keep records.
Article 42 A veterinary drug trading enterprise shall carry out monitoring and management of warehouse temperature and humidity. The warehouse temperature and humidity shall be recorded at fixed times every day. If the warehouse temperature and humidity exceed the specified range, regulation measures shall be taken promptly and recorded.
Article 43 A veterinary drug trading enterprise shall not, in the name of purchasing on behalf of others, selling on behalf of others or display, display, store or sell veterinary drugs that have not undergone quality assessment or other products used for the prevention and treatment of animal diseases or the promotion of growth.
Chapter 7 Sales and Transportation
Article 44 When a veterinary drug trading enterprise sells veterinary drugs, quality management personnel shall be on duty during business hours and wear name badges.
Article 45 When selling veterinary drugs, a veterinary drug trading enterprise shall follow the principle of first-produced-first-out and outbound delivery in order of batch number.
For veterinary drugs of the same batch number, first-in-first-out. Consolidated box products shall be sold first.
Article 46 When veterinary drugs are delivered out of the warehouse, inspection and verification shall be carried out, and outbound records shall be established. The veterinary drug outbound records shall include the generic name, trade name, batch number, dosage form, specification, manufacturer, quantity, date, handler or responsible person of the veterinary drug, etc.
Veterinary drugs under any of the following circumstances shall not be delivered out of the warehouse for sale:
(1) Those whose labels and instructions are illegible or have fallen off;
(2) Those whose inner or outer packaging is damaged, whose seals are not firm, or whose sealing strips are seriously damaged;
(3) Those beyond the expiry date;
(4) Other cases not complying with the provisions on qualified veterinary drug quality.
Article 47 When selling veterinary drugs, a veterinary drug trading enterprise shall issue valid vouchers, so that valid vouchers, accounts, goods and records are consistent, and the sales receipt shall be given to the purchaser for retention.
Article 48 When selling veterinary prescription drugs, a veterinary drug trading enterprise shall comply with the provisions on the administration of veterinary prescription drugs, and issue them strictly after checking against the prescription issued by a practicing veterinary physician or personnel of equivalent qualifications recognized by the Ministry of Agriculture and the provincial veterinary administrative department, in accordance with the usage and dosage of the veterinary drug product, without error.
A veterinary drug trading enterprise shall not arbitrarily change the veterinary drugs listed in a prescription issued by a practicing veterinarian. If the prescription contains incompatible drugs, overdosage or state-prohibited veterinary drugs or other problems violating veterinary drug provisions, they shall not be sold, and the prescription slip shall be returned.
Veterinary prescription drugs shall not be sold by the open-shelf self-selection method.
When selling Chinese medicinal materials and Chinese medicinal decoction pieces for veterinary use, the place of origin shall be indicated.
Article 49 When selling veterinary drugs wholesale to other veterinary drug trading enterprises, the original packaging of the veterinary drug manufacturer shall be used, and sales by breaking boxes (barrels) shall not be allowed.
When selling veterinary drugs in broken quantities, the smallest sales unit shall not be broken open, and a copy of the label and instructions of the veterinary drug product shall be attached.
Article 50 After selling veterinary drugs, a veterinary drug trading enterprise shall establish veterinary drug sales records by variety and batch. The sales records shall state the generic name, trade name, approval number, batch number, expiry date, dosage form, specification, manufacturer, purchasing unit, sales quantity, sales date, handler or responsible person of the veterinary drug, etc.
Article 51 A veterinary drug trading enterprise shall take corresponding measures according to the dosage form, packaging and transportation distance of the veterinary drugs transported to prevent damage and confusion of veterinary drugs.
The handling and storage of veterinary drugs shall strictly comply with the requirements of the pictorial marks on the outer packaging of veterinary drugs, be handled gently, and operated in a standardized manner.
For veterinary drugs with temperature control requirements, necessary temperature control measures shall be taken during long-distance transportation; the transportation of veterinary biological products shall use refrigerated trucks or corresponding refrigerated and insulated facilities, and detailed time records shall be established.
Article 52 Veterinary drug transportation and delivery shall have clear orders for varieties and quantities and clear delivery locations.
Veterinary drugs shall not be arbitrarily transported for business or promotion in other places; prescription veterinary drugs shall not be carried to animal farms (households) or other places for promotion; no unit or individual shall transport counterfeit or inferior veterinary drugs.
Chapter 8 After-Sales Service
Article 53 When conducting publicity, promotion, exhibition, advertising and other activities, a veterinary drug trading enterprise shall take the veterinary drug labels and instructions approved by the Ministry of Agriculture as the standard, and shall not make false or exaggerated publicity or mislead purchasers.
Article 54 A veterinary drug trading enterprise shall pay attention to collecting information on the use of veterinary drugs, and upon discovering serious adverse reactions to veterinary drugs, shall immediately report to the supplier and the veterinary administrative department at or above the county level in the locality.
If a veterinary drug trading enterprise discovers unqualified veterinary drugs already sold or veterinary drugs with questionable quality, it shall promptly recover them.
If a veterinary drug trading enterprise discovers that other enterprises produce, deal in or use counterfeit veterinary drugs, inferior veterinary drugs or veterinary drugs of suspicious quality, it shall promptly report to the veterinary administrative department at or above the county level in the locality.
Article 55 A veterinary drug trading enterprise shall provide technical consulting services, explain the usage and dosage of veterinary drugs to purchasers, correctly guide purchasers to use veterinary drugs scientifically, safely and reasonably, and conduct follow-up surveys on the use of veterinary drugs and establish records.
A veterinary drug trading enterprise shall truthfully record veterinary drug complaints, quality consultations and medication accidents, promptly ascertain the causes, and take effective handling measures.
Article 56 The veterinary drug advertising leaflets, pictorials and other materials posted by a veterinary drug trading enterprise on its business premises shall comply with the relevant state provisions. Publicity that has not obtained a veterinary drug advertisement review approval number in accordance with the law shall not be posted or published.
Article 57 A veterinary drug trading enterprise shall accept and actively cooperate with inspection and sampling activities organized by the veterinary administrative department at or above the county level, and shall not refuse.
Article 58 A veterinary drug trading enterprise must set up a computer management information system to comprehensively record information on business management and other aspects.
Article 59 A veterinary drug trading enterprise shall, in December each year, submit to the county-level veterinary administrative department in the locality a report on the year's veterinary drug business, quality control, implementation of veterinary drug GSP and self-inspection, and shall ensure the authenticity of the materials and shall not resort to deception.
Article 60 For veterinary drug (including non-compulsory immunization veterinary biological products and imported veterinary biological products) stores organized and operated by prefecture (city), county and township veterinary stations (epidemic control centers), the property rights of the store must be transferred to an enterprise or individual (must be a non-employed person in the animal husbandry and veterinary system) before a GSP certification application may be submitted.
Chapter 9 Supplementary Provisions
Article 61 The nature of veterinary drug trading enterprises in these Rules includes enterprises, sole proprietorship enterprises and individual industrial and commercial households.
Article 62 The scope of veterinary drug business involved in these Rules includes the following categories: veterinary chemical drugs, traditional Chinese medicine preparations, biochemical drugs, external insecticides, disinfectants, bulk drugs, Chinese medicinal materials (Chinese medicinal decoction pieces), special drugs (veterinary narcotic drugs, psychotropic drugs, precursor chemicals, toxic drugs, radioactive drugs) and veterinary biological products, etc.
Article 63 These Rules shall come into force as of March 1, 2010.
Veterinary drug trading enterprises already established before these Rules come into force shall meet the requirements of these Rules before March 1, 2012, and apply for a veterinary drug business license in accordance with the law.