Detailed rules for the implementation of quality Management Standards for Veterinary drugs in Yunnan Province

Chapter I General provisions

Article 1 in order to strengthen the quality management of veterinary drugs and ensure the quality of veterinary drugs, these detailed rules are formulated in accordance with the regulations on the Administration of Veterinary drugs and the quality Management Standards of Veterinary drugs of the Ministry of Agriculture.

Article 2 these rules shall apply to veterinary drug trading enterprises in Yunnan Province.

Chapter II places and facilities

Article 3 Veterinary drug trading enterprises 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 and scale of veterinary drugs operated. The area of the business premises of the veterinary drug trading enterprises in the county seat shall not be less than 30 square meters, and the business premises of the veterinary drug trading enterprises in villages and towns and below shall not be less than 20 square meters. Veterinary drug management areas, living areas and animal diagnosis and treatment areas shall be set up separately to avoid cross-contamination. Enterprises engaged in animal diagnosis and treatment activities and concurrently engaged in veterinary drugs shall have independent areas for veterinary drug business activities.

Article 4 the business place of a veterinary drug trading enterprise shall be the same as that specified in the Veterinary Drug Trading license. The license for the Operation of Veterinary drugs shall be hung in a prominent position in the business premises.

If the place of business is changed, an application shall be made for the renewal of the license for veterinary drug business.

If the area of the business premises is changed, it shall be submitted to the license issuing authority for the record within 30 working days after the change.

Article 5 Veterinary drug trading enterprises shall have warehouses and related facilities and equipment suitable for the varieties and scale of veterinary drugs operated and capable of ensuring the quality of veterinary drugs, such as normal temperature warehouses, cool warehouses (cabinets), cold warehouses (cabinets) and so on. Small veterinary drug trading enterprises set up in township areas and veterinary drug trading enterprises specializing in pet diagnosis and treatment may only set up shady warehouses according to the storage conditions of the varieties of veterinary drugs they operate.

Veterinary drug trading enterprises dealing in large quantities of solid disinfectants shall set up an independent special database of solid disinfectants, whose area shall be commensurate with the variety and scale of the solid disinfectants they operate, and shall be equipped with corresponding fire control facilities.

The warehouse area of the veterinary drug management enterprises in the county seat shall not be less than 50 square meters, and the warehouse area of the veterinary drug management enterprises in the township location shall not be less than 20 square meters. The relevant facilities and equipment shall meet the requirements of the division of different areas, such as qualified veterinary drug areas, unqualified veterinary drug areas, veterinary drug areas to be tested and returned veterinary drug areas, as well as the zoning, classified storage and storage of different veterinary drug varieties, and ensure adequate operating space to minimize errors and cross-contamination. Obvious signs shall be set up for all kinds of regions and varieties.

Anyone who changes the location of the warehouse and increases or decreases the number and area of the warehouse as well as related facilities and equipment shall, within 30 working days after the change, report to the license issuing authority for the record.

Article 6 for chain enterprises directly engaged in veterinary drugs with unified warehousing in the same county (city), each chain store shall, according to the needs of the variety and scale of operation, set up a certain area of room temperature warehouse, shade warehouse, etc., for temporary storage of retail veterinary drugs in stores.

Article 7 the shelves, counters and related facilities and equipment of veterinary drug trading places shall be complete, neat and in good condition, capable of displaying all the varieties of veterinary drugs they operate, and shall set up eye-catching marks according to the varieties, categories and uses of veterinary drugs.

Article 8 the business premises of veterinary drug trading enterprises and the floors, walls and ceilings of warehouses shall be flat, dry and clean; doors and windows shall be tightly structured and can be locked and closed and easy to clean.

Article 9 Veterinary drug trading sites shall have the following facilities and equipment:

(1) the display shelves, counters, shelves and counters appropriate to the varieties of veterinary drugs they operate shall account for more than 1/3 of the area of the business premises.

(2) Veterinary drug business premises shall have ventilation, fire prevention and lighting facilities and equipment

(3) if there is a need for light avoidance and temperature control display of veterinary drugs, they shall have temperature, humidity, lighting and other control facilities, equipment and monitoring instruments that meet the requirements of veterinary drug display.

(4) facilities and equipment against dust, moisture, mildew, pollution, insect, rat and bird

(5) Environmental and personnel hygiene, clean facilities, equipment, etc.

(6) to set up a publicity board on the quality information of veterinary drugs in a prominent position in the business premises, post the laws and regulations on the administration of veterinary drugs, the duties and responsibilities of personnel and the division of labor, clearly indicate the service convention, quality commitment and service supervision telephone number, and set up a suggestion book.

Article 10 the veterinary drug storage warehouse shall have the following facilities and equipment:

(1) set up a moisture-proof partition or shelf for veterinary drugs, which should be kept at a distance of 10 cm from the ground

(2) having facilities and equipment against insects, rodents, birds, fire prevention, ventilation, lighting, etc.

(3) isolation facilities to prevent confusion and contamination between different varieties and batches of veterinary drugs

(4) having tools and equipment for unpacking and packing veterinary drugs

(5) Veterinary drugs with special requirements for avoiding light and temperature control shall have corresponding control facilities, equipment and monitoring instruments

Article 11 an enterprise dealing in veterinary biological products shall have storage and transportation facilities commensurate with the scale of its operation:

(1) there shall be at least one independent cold storage, with a capacity of no less than 20 cubic meters, and equipped with 3mur5 cubic meters of freezers and more than 200 liters of refrigerators.

(2) Vaccine transportation shall have necessary measures for heat preservation or cold storage, and shall meet the environmental requirements such as the temperature required for the transport of veterinary biological products.

Article 12 facilities and equipment for the storage of veterinary biological products shall meet the following conditions:

(1) Cold storage (cabinets) shall be equipped with two-way power supply lines or backup generator sets

(2) the temperature of the cold storage should meet the storage requirements of the vaccine, in which the temperature of the ordinary cold storage (cabinet) is 2-8 ℃, and the temperature of the low temperature cold storage (cabinet) is below-15 ℃. If there are products with special requirements, the storage conditions shall conform to the product instructions.

(3) the cold storage shall have devices for automatic temperature monitoring, regulation, recording and alarm.

Article 13 the floor, wall and roof of the cold storage shall be smooth and smooth, and there shall be equipment and measures to maintain the corresponding spacing or isolation between the vaccine and the ground, wall, roof and condenser.

Article 14 there shall be lighting facilities in the cold storage that meet the requirements for safe use of electricity.

Article 15 the cold storage shall be divided into special places such as inspection area, qualified product area, delivery area, return area and so on. All the above districts should have obvious signs and implement color standard management.

Article 16 there shall be workplaces suitable for dismantling and LCL delivery in the cold storage.

Article 17 the receiving places of vaccines shall meet the requirements for vaccine storage.

Article 18 those dealing in traditional Chinese medicine and prepared slices of traditional Chinese medicine shall set up a specimen room (cabinet) of traditional Chinese medicine.

Article 19 the trading of veterinary psychotropic drugs, toxic drugs, narcotic drugs, radioactive drugs, precursor chemicals and other special drugs shall abide by the relevant provisions of the State. At the same time, there shall be independent warehouses, or isolated warehouses, or independent storage cabinets, as well as safety facilities and equipment in accordance with the relevant provisions; establish a special safe storage and prevention system, and take effective preventive measures for safe storage, implement the double-lock safekeeping system.

Article 20 Veterinary drug trading enterprises shall carry out effective inspection, repair and maintenance of the facilities and equipment used on a regular basis.

Chapter III institutions and personnel

Article 21 Veterinary drug trading enterprises shall set up fixed and reasonable organizations or personnel for the procurement, storage, sales and quality management of veterinary drugs, and clarify the responsibilities of each organization and personnel.

The persons directly in charge of veterinary drug trading enterprises shall be familiar with the laws, regulations and policies on veterinary drug administration, have relevant professional knowledge of veterinary drugs, and shall receive training and assessment organized by veterinary administrative departments at or above the county level, and take up posts with certificates.

Article 22 Veterinary drug trading enterprises shall be equipped with quality control personnel suitable for the trading of veterinary drugs. If there are conditions, a quality management organization may be established. The responsibilities of the quality management organization are:

(1) to implement the regulations on the Administration of Veterinary drugs and other laws, regulations and administrative rules relating to the administration of veterinary drugs

(2) draft the quality management system of veterinary drugs in enterprises, and guide and supervise the implementation of the system

(3) to be responsible for the quality audit of the supplier and the relevant veterinary drug varieties

(4) to be responsible for establishing the quality files of veterinary drugs operated by enterprises

(5) to be responsible for the inquiry of veterinary drug quality, the investigation, handling and reporting of veterinary drug quality accidents or complaints.

(6) to be responsible for the acceptance of veterinary drugs, guide and supervise the quality work in the process of storage and transportation of veterinary drugs

(7) to be responsible for the examination and approval of substandard veterinary drugs and supervise the disposal process of substandard veterinary drugs

(8) Collection and analysis of quality information of veterinary drugs

(9) to assist in the education or training on the quality management of veterinary drugs for the staff and workers of enterprises

(10) other related work.

If a small retail enterprise fails to set up a quality management organization because of its small scale of operation, it shall set up quality management personnel, whose work shall be carried out in accordance with the functions of the above-mentioned quality management organization.

Enterprises dealing in veterinary biological products must establish quality management institutions and be equipped with not less than 2 quality management personnel.

Article 23 the responsible persons in charge of quality of veterinary drug trading enterprises and the responsible persons of quality management institutions shall have a college degree or above in veterinary medicine, veterinary medicine and other related majors or intermediate or above professional and technical titles in veterinary medicine and veterinary medicine, and be familiar with the laws, regulations and policies on veterinary drug management. For small veterinary drug trading enterprises set up in township areas, the person in charge of quality and the person in charge of the quality management organization (if set up) shall have a technical secondary school degree or above in veterinary medicine, veterinary medicine and other related majors or above professional and technical titles in veterinary medicine, veterinary medicine and other related majors. The person in charge of quality and the person in charge of the quality management institution shall accept the 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 control personnel shall have a technical secondary school degree or above in veterinary medicine, veterinary medicine or other related majors, or professional and technical titles at or above the junior level in veterinary medicine or veterinary medicine, they shall receive training and assessment organized by veterinary administrative departments at or above the county level and take up posts with certificates. For those dealing in veterinary biological products, the veterinary drug quality control personnel shall have a college degree or above in veterinary medicine, veterinary medicine and other related majors, or have intermediate or above professional and technical titles in veterinary medicine, veterinary medicine and other related specialties, and have professional knowledge in the production, transportation, storage, quality inspection and use of veterinary biological products.

When there is a change in the person in charge of quality, the person in charge of the quality management department and the quality management personnel, they shall, within 30 working days after the change, report to the license issuing authority for the record.

Article 24 personnel engaged in the procurement, storage, sales and technical services of veterinary drugs in veterinary drug trading enterprises shall have at least one senior high school education and professional knowledge of veterinary drugs and veterinary surgeons, and be familiar with the laws, regulations and policies on veterinary drug management.

Article 25 the personnel responsible for prescribing in a veterinary drug trading enterprise shall have a junior college degree or above from the University of Veterinary Medicine, Animal Husbandry and Veterinary Medicine or Chinese Veterinary Medicine (ethnic Veterinary Medicine), or have the professional and technical title of intermediate veterinary officer or above, or obtain the qualification certificate of a licensed veterinarian approved by the Ministry of Agriculture and the provincial veterinary administrative department, and have the ability to correctly judge and deal with the clinical use of animal drugs and the safe use of veterinary drugs.

Article 26 Veterinary drug trading enterprises shall formulate training plans, conduct regular training and assessment of veterinary drug management laws, regulations, policies and regulations, veterinary drugs, veterinary surgeons and other relevant professional knowledge and professional ethics, and establish training and assessment files.

Chapter IV rules and regulations

Article 27 Veterinary drug trading enterprises shall establish a quality management system, formulate quality management documents such as management systems and operating procedures, form quality manuals, and regularly inspect and assess their implementation.

The quality management documents shall include the following contents:

(1) quality management objectives of enterprises

(2) the organizational structure, posts and personnel responsibilities of the enterprise

(3) quality evaluation system for suppliers and procurement of veterinary drugs

(4) the management system for the procurement, acceptance, storage, display, storage, transportation, sale and exit of veterinary drugs

(5) Environmental hygiene management system

(6) reporting system of adverse reactions to veterinary drugs

(7) Management system for substandard veterinary drugs and returned veterinary drugs

(8) Management system for quality accidents, quality inquiries and quality complaints

(IX) Management system of enterprise records, archives and vouchers

(10) quality management training and assessment management system

Article 28 the quality management records of veterinary drug trading enterprises shall be true, accurate, complete and clear, and shall not be altered, forged or altered at will. If it really needs to be amended, it shall be signed and dated, and the original data shall be clearly discernible. The record should be signed by the person who handled it or the responsible person to ensure the traceability of veterinary drug products and related personnel.

The record should include the following:

(1) Records of personnel training and assessment

(2) maintenance, cleaning and running status records of facilities and equipment for controlling temperature and humidity

(3) record of quality evaluation of veterinary drugs

(4) record of purchase, acceptance, storage, sale and exit of veterinary drugs

(5) Veterinary drug inventory records

(6) record of quality disassembly, quality disputes, quality accidents and adverse reactions of veterinary drugs

(7) record of disposal of substandard veterinary drugs and returned veterinary drugs

(8) the record of supervision and inspection of the veterinary administrative department.

Article 29 Veterinary drug trading enterprises shall establish veterinary drug quality control files, set up file management rooms or filing cabinets, and shall be responsible for by special personnel.

Quality management files should include:

(1) personnel files, training files, equipment and facilities files, supplier quality evaluation files, product quality files

(2) prescriptions, purchase and sales vouchers issued

(3) purchase and sale records and other records required by this Code.

The quality management files shall not be altered, and the retention period shall not be less than 2 years; the purchase and sale records and certificates shall be kept until one year after the expiration date of the product.

Chapter V Purchasing and Storage

Article 30 Veterinary drug trading enterprises shall purchase veterinary drugs in accordance with the following procedures:

(1) to determine the qualification and quality reputation of the supplier

(2) to examine and verify the legality, quality and reliability of veterinary drugs purchased

(3) to confirm the legal qualifications of the sales personnel of the supply units who are in business contact with the enterprise

(4) for the varieties operated for the first time, the examination and approval form for the purchased veterinary drug varieties shall be filled in and shall be examined and approved by the enterprise quality management organization and the leader in charge.

(5) sign a procurement contract with clear quality terms

(6) to report to the veterinary administrative department at the county level for the record.

Article 31 the examination and approval of the qualifications of supply units shall include the following contents:

(1) Business license

(2) Veterinary Drug production license and Veterinary Drug GMP Certificate (the supplier is the production enterprise)

(3) the license for the operation of veterinary drugs (the supplier is the operating enterprise).

Article 32 the examination and approval of the legality and quality of varieties for the first time shall include the following contents:

(1) to verify the product approval number of veterinary drugs

(2) quality standards and inspection reports of veterinary drugs

(3) to examine whether the labels and instructions of veterinary drugs are in compliance with the regulations.

(4) to understand the performance, use, storage conditions, quality and reputation of veterinary drugs

(5) those who import veterinary drugs shall verify the registration certificate of imported veterinary drugs, import license for veterinary biological products, customs clearance form for imported veterinary drugs, etc.

Article 33 when purchasing veterinary drugs, a veterinary drug trading enterprise shall sign a procurement contract with the supplier. The contents of the contract shall have provisions to ensure the quality of veterinary drugs.

Veterinary drug trading enterprises shall keep valid vouchers for purchasing veterinary drugs, establish true and complete procurement records, and ensure that valid vouchers, accounts and goods match.

The purchase record shall include the general name, commodity name, approval number, batch number, dosage form, specification, validity period, production unit, supply unit, purchase quantity, purchase date, handling person or person in charge of the veterinary drug.

Article 34 when purchasing veterinary drugs, veterinary drug trading enterprises must strictly implement the purchase inspection and acceptance system, verify the product qualification certificates, packaging, labels and instructions, and establish a product purchase ledger, request a copy of the inspection report issued by the inspection institution that meets the statutory requirements from the supplier in accordance with the production batches, and purchase only if it meets the requirements.

The purchase of veterinary biological products shall be inspected and accepted by two or more people.

When necessary, the purchased veterinary drugs shall be inspected or the veterinary drug inspection institutions shall be entrusted for inspection, and the inspection report shall be kept together with the product quality files.

Article 35 Veterinary drugs under any of the following circumstances shall not be put into storage:

(1) having not been evaluated or inconsistent with the quality evaluation information of the supplier

(2) those not in conformity with the procurement contract and invoice

(3) where the damage of the inner and outer packaging may affect the quality of the product, there are no labels or instructions, or the labels or instructions are ambiguous

(4) where the approval number and validity period of veterinary drug products have expired

(5) failing to pass the quality inspection and acceptance

(6) other cases that do not comply with laws and regulations and the quality provisions of veterinary drugs.

Article 36 the inspection of veterinary drugs shall be carried out under an environment that does not affect the quality of veterinary drugs.

Chapter VI display and Storage

Article 37 qualified veterinary drug products shall be stored in storage in accordance with the different storage conditions of veterinary drug products, label management shall be carried out, and a location card shall be established.

After the veterinary drug products are put into storage, a certain number of samples should be selected for each variety according to the storage conditions of veterinary drug products, and the samples shall be classified and displayed on the shelves and counters under suitable conditions in the business place.

Large packages of veterinary drugs, APIs, dangerous drugs, and veterinary drug products with special requirements for environmental temperature, humidity and light can only display empty packaging, product labels or photos.

Article 38 the display and storage of veterinary drugs shall meet the following requirements:

(1) classification, division or special storage according to the storage requirements of variety, category, use, temperature, humidity, etc.

(2) handling and storage in accordance with the requirements of the illustrated marks for the outer packaging of veterinary drugs

(3) the distance between the warehouse floor and the floor is not less than 10 cm, and the distance between the veterinary medicine and the wall and roof is not less than 30 cm.

(4) Veterinary drugs for internal use and external use shall be stored separately, and prescription veterinary drugs for animal use and over-the-counter drugs shall be stored separately; easy to taste veterinary drugs, toxic veterinary drugs and special controlled drugs shall be stored in separate warehouses with other veterinary drugs, veterinary drugs containing flammable, explosive ingredients and corrosive veterinary drugs shall be managed in accordance with dangerous goods and stored in separate warehouses from other veterinary drugs, and the storage warehouse shall be relatively independent and isolated.

(5) separate storage of veterinary drugs to be tested, qualified veterinary drugs, substandard veterinary drugs and returned veterinary drugs

(6) products of the same batch number of the same enterprise are centrally stored.

Article 39 Veterinary drugs in different regions and types shall have obvious identification marks. The logo should be placed accurately and clearly written.

The category of veterinary drugs shall be marked with color, and the unqualified veterinary drugs shall be marked in red font; the veterinary drugs to be tested and returned shall be marked in yellow font; and the qualified veterinary drugs shall be marked in green font.

Article 40 Veterinary drug trading enterprises shall regularly inspect and record veterinary drugs and their display and storage conditions, as well as the operating status of facilities and equipment.

Article 41 Veterinary drug trading enterprises shall regularly check expired and invalid veterinary drugs, promptly check and withdraw cabinets of fake and inferior veterinary drugs announced by the Ministry of Agriculture and provincial veterinary administrative departments, and keep records.

Article 42 Veterinary drug trading enterprises shall do a good job in monitoring and managing the temperature and humidity of the warehouse. The temperature and humidity of the warehouse shall be recorded regularly every day. If the temperature and humidity of the warehouse exceed the prescribed range, timely regulation and control measures shall be taken and recorded.

Article 43 Veterinary drug trading enterprises shall not display, store or sell veterinary drugs without quality assessment and other products used for animal disease prevention, treatment and growth promotion in the name of purchasing, selling or displaying.

Chapter VII sales and Transportation

Article 44 Veterinary drug trading enterprises that sell veterinary drugs shall have quality control personnel on duty and wear badges during business hours.

Article 45 Veterinary drug trading enterprises shall follow the principle of first-in-first production, first-out and in the order of batch number in the morning and evening when selling veterinary drugs.

Veterinary drugs of the same batch number, first in, first out. Priority is given to the sale of closed-box products.

Article 46 when veterinary drugs are released from the warehouse, inspection and verification shall be carried out and records shall be established. The veterinary drug release record shall include the general name, commodity name, batch number, dosage form, specification, manufacturer, quantity, date, handlers or responsible persons of veterinary drugs.

Veterinary drugs under any of the following circumstances shall not be sold out of the warehouse:

(1) the labels and instructions are ambiguous or fall off

(2) the inner and outer packages are damaged, the seals are not firm, or the seals are seriously damaged

(3) if the term of validity is exceeded

(4) other cases that do not meet the requirements for qualified quality of veterinary drugs.

Article 47 in selling veterinary drugs, veterinary drug trading enterprises shall issue valid vouchers to ensure that the valid vouchers, accounts, goods and records match, and the sales bills shall be kept by the purchasers.

Article 48 Veterinary drug trading enterprises that sell prescription drugs for animal use shall abide by the regulations on the administration of prescription drugs for veterinary use, and shall be issued on the basis of prescriptions issued by licensed veterinary surgeons or equally qualified personnel approved by the Ministry of Agriculture or provincial veterinary administrative departments, in strict accordance with the usage and dosage of veterinary drug products.

Veterinary drug trading enterprises shall not change the veterinary drugs listed in the prescriptions prescribed by licensed veterinary surgeons without authorization. If there are any problems in the prescription that violate the regulations on veterinary drugs, such as incompatibility, over-dose use of drugs or prohibited veterinary drugs prescribed by the state, they shall not be sold and the prescription paper shall be returned.

Prescription drugs for animal use shall not be sold on open shelves of their own choice.

Those who sell veterinary Chinese medicinal materials or prepared pieces of traditional Chinese medicine shall indicate the place of origin.

Article 49 when wholesale selling veterinary drugs to other veterinary drug trading enterprises, the original packaging of the veterinary drug manufacturing enterprises shall be used and shall not be sold in unpacked boxes (buckets).

When selling veterinary drugs, the minimum sales unit shall not be taken apart, and a copy of the label and instruction manual of the veterinary drug product shall be attached.

Article 50 after selling veterinary drugs, veterinary drug trading enterprises shall establish veterinary drug sales records according to varieties and batches. The sales record shall include the general name, commodity name, approval number, batch number, period of validity, dosage form, specification, manufacturer, purchasing unit, sales quantity, date of sale, handlers or persons in charge of veterinary drugs.

Article 51 Veterinary drug trading enterprises shall take corresponding measures according to the dosage form, packaging and transportation distance of veterinary drugs, so as to prevent the damage and confusion of veterinary drugs.

The handling and storage of veterinary drugs should strictly abide by the requirements of the graphic signs of the outer packaging of veterinary drugs, handle them gently and standardize the operation.

For veterinary drugs with temperature control requirements, necessary temperature control measures should be taken when transported for a long time, and refrigerated vehicles or corresponding refrigerated heat preservation facilities should be used for the transportation of veterinary biological products, and detailed time records should be established.

Article 52 Veterinary drugs shall be transported and delivered with a clear variety, quantity order and delivery place.

Veterinary drugs shall not be transported at will, sold or marketed in other places; prescription veterinary drugs shall not be carried to animal farms (households) for promotion; no unit or individual shall transport fake or inferior animal drugs.

Chapter VIII after-sales Service

Article 53 when conducting publicity, promotion, exhibition, advertising and other activities, veterinary drug trading enterprises shall follow the veterinary drug labels and instructions approved by the Ministry of Agriculture, and shall not falsely exaggerate publicity or mislead buyers.

Article 54 Veterinary drug trading enterprises shall pay attention to collecting information on the use of veterinary drugs, and when serious adverse reactions of veterinary drugs are found, they shall immediately report to the supply unit and the veterinary administrative department at or above the county level where they are located.

The veterinary drug trading enterprise shall recover the substandard veterinary drugs that have been sold or the veterinary drugs whose quality is in doubt.

When a veterinary drug trading enterprise discovers that other enterprises produce, operate and use fake veterinary drugs, inferior veterinary drugs, or veterinary drugs of dubious quality, they shall promptly report to the local veterinary administrative department at or above the county level.

Article 55 Veterinary drug trading enterprises shall provide technical advisory services, explain the usage and dosage of veterinary drugs to buyers, correctly guide purchasers to use veterinary drugs scientifically, safely and rationally, and conduct a return visit to investigate the use of veterinary drugs and establish records.

Veterinary drug management enterprises shall truthfully record veterinary drug complaints, quality consultation and drug accidents, find out the causes in time and take effective measures to deal with them.

Article 56 the veterinary drug advertising leaflets, pictorials and other materials posted by veterinary drug trading enterprises in the business premises shall comply with the relevant provisions of the State. It is not allowed to post or publish publicity that has not obtained the examination and approval number of veterinary drug advertisements according to law.

Article 57 Veterinary drug trading enterprises shall accept and actively cooperate with the inspection and sampling activities organized by the veterinary administrative departments at or above the county level and shall not refuse.

Article 58 Veterinary drug trading enterprises must set up a computer management information system to comprehensively record information on operation and management.

Article 59 Veterinary drug trading enterprises shall submit annual reports on veterinary drug trading, quality control, GSP implementation and self-examination to the veterinary administrative departments at the county level where they are located in December of each year, and shall ensure the authenticity of the materials and shall not practise fraud.

Article 60 Veterinary drugs (including non-compulsory immunization veterinary biological products and imported veterinary biological products) organized and operated by state (city), county and township veterinary stations (epidemic control centers) must transfer the property rights to enterprises or individuals (must be non-employed personnel in the animal husbandry and veterinary system) before applying for GSP certification.

Chapter IX 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 business scope of veterinary drugs involved in these Rules includes the following categories: veterinary chemicals, traditional Chinese medicine preparations, biochemical drugs, pesticides for external use, disinfectants, raw materials, traditional Chinese medicine (Chinese herbal pieces), special drugs (veterinary narcotic drugs, psychotropic drugs, precursor chemicals, toxic drugs, radioactive drugs) and veterinary biological products.

Article 63 These Rules shall come into force as of March 1, 2010.

Veterinary drug distributors established before the implementation of these Rules shall meet the requirements of these Rules before March 1, 2012 and apply for veterinary drug distribution licenses according to law.