Chapter I General Principles
Article 1 In order to strengthen drug supervision and administration, standardize drug business order and ensure drug quality and safety, these Measures are formulated in accordance with the Drug Administration Law of People's Republic of China (PRC), the Regulations for the Implementation of the Drug Administration Law of People's Republic of China (PRC) and other laws and regulations, combined with the actual situation of this Municipality.
Article 2 Units or individuals engaged in drug wholesale, retail, drug storage, transportation, supervision and management within the administrative area of this Municipality shall abide by these Measures.
Article 3 The food and drug supervision and administration departments of cities and counties (cities) shall be responsible for the supervision and administration of drug transactions within their respective administrative areas.
Industry and commerce, health, transportation and other administrative departments. Responsible for the supervision and administration of drug trading within their respective functions and duties.
Township people's governments and sub-district offices shall assist the food and drug supervision and management departments to do a good job in the supervision and management of drug business within their respective jurisdictions.
Article 4 Pharmaceutical trade associations shall strengthen the supervision and management of the industry, give play to the role of self-discipline of the industry, and promote the pharmaceutical industry to operate according to law.
Chapter II Management of Business Behavior
Article 5 To set up a pharmaceutical trading enterprise, it shall meet the conditions prescribed by laws and regulations, and go through relevant procedures such as administrative licensing and industrial and commercial registration according to law.
Article 6 A pharmaceutical trading enterprise shall bear legal responsibility for the pharmaceutical trading activities conducted by its branches or sales personnel in the name of the enterprise.
Article 7 A pharmaceutical trading enterprise shall establish a computer management information system, truthfully record the purchase, storage and sales of drugs through the computer, and timely and accurately report the data of drug purchase, storage and sales of the enterprise according to the requirements of the food and drug supervision and administration department.
Article 8 Pharmaceutical trading enterprises shall keep the area and layout of pharmaceutical trading places relatively stable. If the area and layout of drug business premises need to be adjusted due to business management, the business conditions shall not be lowered, and it shall be reported to the food and drug supervision and administration department for the record within 15 days from the date of adjustment.
Article 9 Where a pharmaceutical trading enterprise entrusts a pharmaceutical logistics enterprise to undertake the transportation or storage of drugs, it shall be responsible for the quality and safety of drugs during transportation or storage. For the transportation or storage of drugs with temperature requirements, pharmaceutical trading enterprises shall urge logistics enterprises to take necessary heat preservation or cold storage measures in accordance with regulations.
If a pharmaceutical trading enterprise delivers drugs by postal service or express delivery company, it shall produce relevant materials to prove the legality of the drugs; Postal business organizations or courier companies shall conduct on-site inspection.
The transportation, storage and mailing of narcotic drugs, psychotropic drugs, toxic drugs for medical use and radioactive drugs shall be handled in accordance with relevant regulations.
Article 10 A pharmaceutical wholesale enterprise selling non-first-sale drugs may directly transfer drugs from pharmaceutical production enterprises or other pharmaceutical wholesale enterprises to purchasing enterprises, but it must be checked and accepted by the quality management personnel of the enterprise and recorded in accordance with regulations.
Article 11 When dealing in compound preparations containing special drugs, pharmaceutical wholesale enterprises shall establish customer files, verify and keep the qualification certificates of buyers and sellers, power of attorney of legal persons of buyers and sellers and copies of identity certificates.
Article 12 pharmaceutical trading enterprises shall issue sales vouchers in accordance with regulations when selling drugs.
Thirteenth pharmaceutical trading enterprises should have legal bills to buy drugs, and establish the purchase and acceptance records in accordance with the provisions; Drugs whose bills do not meet the requirements or whose tickets, accounts and goods do not match shall not be accepted and put into storage.
When purchasing drugs, pharmaceutical trading enterprises shall receive the donated drugs, obtain the corresponding vouchers to prove the legal source of the drugs, and conduct acceptance inspection in accordance with the regulations.
Article 14 When a pharmaceutical trading enterprise purchases and sells drugs, the names of the buyers and sellers recorded in the sales voucher shall be consistent with the actual payment flow, and the purchase and sale amount shall correspond to the relevant financial accounts of the buyers and sellers.
Fifteenth pharmaceutical retail enterprises shall implement the provisions on the classified management of prescription drugs and over-the-counter drugs, and sell prescription drugs according to the provisions.
Article 16 When selling compound preparations containing special drugs, pharmaceutical retail enterprises shall register their identities in accordance with the regulations, and the sales shall not exceed the prescribed quantity at one time, and may not directly sell drugs to minors.
Seventeenth without the approval of the administrative department of health, pharmaceutical retail enterprises shall not carry out medical activities in their business premises. Engaged in medical activities with the approval of the administrative department of health, there should be obvious physical separation between the drug sales area and the medical area.
Article 18 A pharmaceutical trading enterprise shall deal in pharmaceuticals in accordance with the mode and scope of business permitted by the Pharmaceutical Trading License.
Article 19 Where a pharmaceutical trading enterprise concurrently deals in products other than pharmaceuticals, it shall store and display pharmaceuticals and other products in different regions, and set up obvious signs.
The following products shall not be sold in pharmaceutical trading enterprises:
(1) Products with generic names, trade names or other reference names that have been approved for registration as drug names;
(2) Products that are publicized on packaging, labels, instructions and related publicity materials for diagnosis, treatment, relief or prevention;
(3) Products with illegally added pharmaceutical ingredients.
Article 20 pharmaceutical trading enterprises shall not introduce indications or functional indications of drugs beyond the scope approved by the state food and drug supervision and administration department by means of entrainment in drug packaging or attaching publicity materials with drugs.
Twenty-first pharmaceutical trading enterprises should regularly check the quality and storage conditions of drugs in stock, and make records; The expired, contaminated, deteriorated and other unqualified drugs shall be registered and destroyed in accordance with relevant regulations.
Article 22 A pharmaceutical trading enterprise shall not provide conditions for other units or individuals to trade drugs in its own name by inviting investment, exhibiting, renting counters, contracting, and invoicing on its behalf.
Article 23 When a pharmaceutical trading enterprise donates drugs, it shall provide the donee with copies of the Pharmaceutical Trading License, the Drug Approval Certificate, the drug inspection report issued by the pharmaceutical production enterprise or legal institution, and other relevant materials stipulated by the state.
The actual validity period of donated drugs shall not be less than 6 months.
Article 24 This Municipality shall evaluate the credit rating of pharmaceutical trading enterprises, and the specific evaluation standards and measures shall be formulated by the municipal food and drug supervision and administration department.
Chapter III Staff Management
Article 25 The person in charge of a pharmaceutical trading enterprise shall be familiar with the laws, regulations and rules of pharmaceutical management and the basic knowledge of the drugs it deals in, and shall be responsible for the quality of the drugs it deals in.
Article 26 Quality management personnel and drug acceptance personnel of pharmaceutical trading enterprises shall have pharmaceutical or related professional qualifications, or have pharmaceutical professional and technical titles.
Prescription examiners of pharmaceutical retail enterprises shall have professional and technical titles of pharmacists or above.
Article 27 The quality management personnel, inspection personnel, acceptance personnel, storage personnel, maintenance personnel and business personnel of a pharmaceutical trading enterprise shall receive professional training organized by the food and drug supervision and administration department, and take up their posts with certificates after passing the examination.
Article 28 Quality management and inspection personnel of pharmaceutical retail enterprises shall be on-the-job and may not work part-time in other enterprises.
Twenty-ninth pharmaceutical trading enterprises shall organize the personnel who have direct contact with drugs to carry out health examination every year and establish health records. Persons who are found to be suffering from mental illness, infectious diseases and other diseases that may pollute drugs shall be transferred from their posts in time.
Article 30 Sales personnel of pharmaceutical production and wholesale enterprises shall not sell drugs beyond the business scope entrusted by the enterprise, sell drugs along the way, set up stalls to sell or illegally publicize drugs, and shall not unpack or modify drugs without authorization.