Article 2 This Code is applicable to veterinary drug trading enterprises in People's Republic of China (PRC). Article 3 A veterinary drug trading enterprise shall have a fixed business place and warehouse, the area of which shall conform to the provisions of the veterinary administrative department of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government. The business premises and warehouses shall be reasonably laid out and relatively independent.
The area, facilities and equipment of the business premises shall be suitable for the variety and business scale of veterinary drugs. Veterinary drug business areas, living areas and animal treatment areas should be set up independently to avoid cross-contamination.
Article 4 The business premises of a veterinary drug trading enterprise shall be the same as those specified in the Veterinary Drug Business License. "Veterinary drug business license" should be hung in a prominent position in the business premises.
Where the business premises are changed, it shall apply for renewal of the business license for veterinary drugs.
Where 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 relevant facilities and equipment such as normal temperature warehouse, cold storage warehouse (cabinet) and cold storage (cabinet) which are suitable for the variety and scale of veterinary drugs it operates and can ensure the quality of veterinary drugs.
The warehouse area and related facilities and equipment should meet the requirements of different areas such as qualified veterinary drug area, unqualified veterinary drug area, veterinary drug area to be inspected and returned veterinary drug area, as well as the requirements of different veterinary drug varieties, classified custody and storage.
The change of warehouse location, the increase or decrease of warehouse quantity, area and related facilities and equipment shall be filed with the issuing authority within 30 working days after the change.
Article 6 Where a veterinary drug direct chain operation enterprise has more than one store in the same county (city), it can uniformly allocate warehousing and related facilities and equipment.
Article 7 The floors, walls and ceilings of the business premises and warehouses of veterinary drug trading enterprises shall be smooth and tidy, and the doors and windows shall be tight and easy to clean.
Article 8 The business premises and warehouses of a veterinary drug trading enterprise shall have the following facilities and equipment:
(1) Shelves and counters suitable for dealing in veterinary drugs;
(2) Having facilities and equipment that are protected from light, ventilation and lighting;
(3) Having temperature and humidity control facilities and equipment suitable for the storage of veterinary drugs;
(4) Facilities and equipment that are dust-proof, moisture-proof, mildew-proof, pollution-proof, insect-proof, rat-proof and bird-proof;
(5) Sanitary and cleaning facilities and equipment.
Article 9 The facilities and equipment of the business premises and warehouses of veterinary drug trading enterprises shall be complete, neat and intact, and eye-catching signs shall be set according to the varieties, categories and uses of veterinary drugs. Article 10 The person directly in charge of a veterinary drug trading enterprise shall be familiar with the laws, regulations and policies on veterinary drug management and have the corresponding professional knowledge of veterinary drugs.
Eleventh veterinary drug management enterprises should be equipped with quality management personnel suitable for veterinary drug management. Conditional, you can establish a quality management organization.
Article 12 The person-in-charge of the quality of a veterinary drug trading enterprise and the person-in-charge of the quality management institution shall have the corresponding professional knowledge of veterinary drugs, and their professional qualifications or technical titles shall conform to the provisions of the veterinary administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government.
Veterinary drug quality management personnel should have a technical secondary school degree or above in veterinary drugs, veterinary drugs and other related majors, or have a junior professional title or above in veterinary drugs, veterinary drugs and other related majors. Veterinary biological products management and veterinary drug quality management personnel shall have a college degree or above in veterinary medicine, veterinary medicine and other related majors, or have an intermediate title or above in veterinary medicine, veterinary medicine and other related majors, and have professional knowledge of veterinary biological products.
Veterinary drug quality management personnel shall not work part-time in other units other than enterprises.
If the person in charge of quality, the person in charge of the quality management organization and the quality management personnel change, they shall file with the issuing authority within 30 working days after the change.
Article 13 The personnel engaged in the procurement, storage, sale and technical service of veterinary drugs in a veterinary drug trading enterprise shall have a high school education or above, have corresponding veterinary drugs and veterinary professional knowledge, and be familiar with laws, regulations and policies on veterinary drug management.
Article 14 A veterinary drug trading enterprise shall formulate a training plan, regularly train and assess its employees in veterinary drug management laws, regulations and policies, as well as relevant professional knowledge and professional ethics, and establish training and assessment files. Fifteenth veterinary drug enterprises should establish a quality management system, formulate management systems, operating procedures and other quality management documents.
Quality management documents shall include the following contents:
(a) enterprise quality management objectives;
(two) the organization, post and personnel responsibilities of the enterprise;
(3) Quality evaluation system for suppliers and purchased veterinary drugs;
(four) the management system of veterinary drug procurement, acceptance, warehousing, display, storage, transportation, sales, warehousing and other links;
(5) Environmental sanitation management system;
(6) Reporting system for adverse drug reactions of veterinary drugs;
(seven) the management system of unqualified veterinary drugs and returned veterinary drugs;
(eight) quality accidents, quality inquiries and quality complaints management system;
(nine) the management system of enterprise records, files and vouchers;
(ten) quality management training and assessment system.
Article 16 A veterinary drug trading enterprise shall establish the following records:
(a) personnel training and assessment records;
(2) Maintenance, maintenance, cleaning and operation status records of temperature and humidity control facilities and equipment;
(3) Veterinary drug quality evaluation records;
(4) Records on the purchase, acceptance, warehousing, storage, sales and delivery of veterinary drugs;
(five) veterinary drug inventory records;
(six) veterinary drug quality complaints, quality disputes, quality accidents, adverse reactions and other records;
(seven) records of unqualified veterinary drugs and returned veterinary drugs;
(eight) the supervision and inspection records of the veterinary administrative department.
Records shall be true, accurate, complete and clear, and shall not be altered, forged or altered at will. If it is really necessary to modify, it should be signed and dated, and the original materials should be clearly identifiable.
Seventeenth veterinary drug management enterprises should establish veterinary drug quality management files, set up file management room or file cabinet, and there is a person in charge.
Quality management documents shall include:
(1) personnel files, training files, equipment and facilities files, supplier quality evaluation files and product quality files;
(2) Prescription, purchase and sale vouchers;
(three) the purchase and sale records and other records stipulated in this specification.
Quality management documents shall not be altered, and the storage period shall not be less than 2 years; Records and vouchers such as purchase and sale shall be kept for one year after the product is valid. Article 18 A veterinary drug trading enterprise shall purchase legal veterinary drug products. Veterinary drug enterprises shall review the qualification, quality assurance ability, quality reputation and product approval documents of suppliers, and sign purchase contracts with suppliers.
Article 19 When purchasing veterinary drugs, a veterinary drug trading enterprise shall inspect the packaging, labels, instructions, quality certificates and other contents of each batch of veterinary drugs in accordance with the national veterinary drug management regulations, veterinary drug standards and contract stipulations, and only those that meet the requirements can purchase them. When necessary, the purchased veterinary drugs shall be inspected or entrusted to a veterinary drug inspection agency for inspection, and the inspection report shall be kept together with the product quality files.
Veterinary drug trading enterprises shall keep valid vouchers for purchasing veterinary drugs, establish true and complete procurement records, and ensure that valid vouchers and accounts are consistent. Procurement records shall specify the common name, trade name, approval number, batch number, dosage form, specification, validity period, production unit, supplier, purchase quantity, purchase date, agent or person in charge, etc.
Article 20 When veterinary drugs are put into storage, they shall be accepted and recorded.
Veterinary drugs under any of the following circumstances shall not be put into storage:
(a) Not in conformity with the purchase order;
(two) the damage of internal and external packaging may affect the quality of products;
(three) there is no logo or the logo is vague;
(4) Abnormal quality;
(five) other non-compliance.
When veterinary biological products are put into storage, there should be more than two people for acceptance. Article 21 The display and storage of veterinary drugs shall meet the following requirements:
(a) according to the variety, category, use and temperature and humidity storage requirements, classification, zoning or special storage;
(2) Handling and storage according to the requirements of graphic signs on veterinary drug packaging;
(3) Keep a certain distance from the floor, wall and roof of the warehouse;
(four) veterinary drugs for internal use and external use are stored separately, and veterinary prescription drugs and over-the-counter drugs are stored separately; Special veterinary drugs such as smelly veterinary drugs and dangerous drugs are stored separately from other veterinary drugs;
(five) veterinary drugs to be inspected, qualified veterinary drugs, unqualified veterinary drugs and returned veterinary drugs are stored in different regions;
(6) Centralized storage of the same batch of products of the same enterprise.
Twenty-second different regions and different types of veterinary drugs should have obvious identification marks. Signs should be placed accurately and clearly.
Unqualified veterinary drugs are identified in red font; Veterinary drugs to be detected and returned are marked in yellow font; Qualified veterinary drugs are identified in green font.
Twenty-third veterinary drug trading enterprises should regularly check the operation status of veterinary drugs and their display, storage conditions, facilities and equipment, and make records.
Twenty-fourth veterinary drug enterprises shall timely check the fake and inferior veterinary drugs published by the veterinary administrative department and make records. Twenty-fifth veterinary drug marketing enterprises should follow the principles of "first production, first output" and "outbound by batch number". Veterinary drugs shall be checked and accepted when leaving the warehouse, and a record of leaving the warehouse shall be established. The delivery record of veterinary drugs shall include the general name, trade name, batch number, dosage form, specification, manufacturer, quantity, date, agent or person in charge, etc.
Veterinary drugs under any of the following circumstances shall not be sold out of the warehouse:
(a) the logo is fuzzy or falls off;
(two) the outer packaging is damaged, the seal is not firm, and the seal is seriously damaged;
(three) beyond the effective period;
(four) other non-compliance.
Twenty-sixth veterinary drug trading enterprises shall establish sales records. Sales records shall contain the general name, trade name, approval number, batch number, validity period, dosage form, specifications, manufacturer, purchasing unit, sales quantity, sales date, agent or person in charge, etc.
Article 27 When selling veterinary drugs, a veterinary drug trading enterprise shall issue a valid certificate to ensure that the valid certificate, account, goods and materials are consistent.
Twenty-eighth veterinary drug enterprises selling veterinary prescription drugs shall abide by the provisions on the administration of veterinary prescription drugs; Sales of veterinary Chinese herbal medicines and Chinese herbal pieces shall indicate the place of origin.
Twenty-ninth veterinary drugs are sold separately, and no minimum sales unit may be set up.
Article 30 A veterinary drug trading enterprise shall transport veterinary drugs according to the requirements of graphic identification of veterinary drug packaging. Veterinary drugs with temperature control requirements should take necessary temperature control measures during transportation and establish detailed records. Thirty-first veterinary drug trading enterprises shall publicize the provisions of veterinary drug labels and instructions approved by the veterinary administrative department, and shall not mislead buyers.
Article 32 A veterinary drug trading enterprise shall provide technical consulting services to the buyers, express the service convention and quality commitment in the business premises, and guide the buyers to use veterinary drugs scientifically, safely and reasonably.
Article 33 A veterinary drug trading enterprise shall pay attention to collecting information on the use of veterinary drugs, and when it finds fake and inferior veterinary drugs, veterinary drugs with doubtful quality and serious adverse reactions of veterinary drugs, it shall promptly report to the local veterinary administrative department and do relevant work in accordance with the regulations. Article 34 A veterinary drug trading enterprise shall also abide by other relevant regulations of the state when dealing in special drugs such as veterinary narcotic drugs, psychotropic drugs, precursor chemicals, toxic drugs and radioactive drugs.
Thirty-fifth animal epidemic prevention institutions engaged in veterinary drug business activities according to law shall abide by this specification.
Article 36 The veterinary administrative departments of the people's governments of all provinces, autonomous regions and municipalities directly under the Central Government may, in accordance with this Code and in light of local conditions, formulate detailed implementation rules and report them to the Ministry of Agriculture for the record.
Article 37 This Code shall come into force on March 1 day, 2065438.
Veterinary drug enterprises established before the implementation of this specification shall meet the requirements of this specification within 24 months from the date of implementation of this specification, and apply for a veterinary drug business license according to law.