Notice of the State Drug Administration on the Interim Provisions on the Management of Prescription Prescription President Medicine and African Medicine Distribution Management

Chapter 1 General Principles 1 In order to strengthen the circulation management of prescription drugs and non -prescription drugs, to ensure the safety, effectiveness, convenience, and timely time of people's drug use, in accordance (Trial), formulate these regulations. Article 2 Any enterprise and medical institutions engaged in drug production, wholesale, retail in China are applicable to these regulations. Article 3 The state's production, sales, wholesale sales, deployment, retail, and use of prescription drugs implemented by special management in accordance with relevant laws and regulations. Article 4 These regulations shall be supervised and implemented by the drug supervision and management department of the county level. Chapter 2 Production and Wholesale Enterprises Sales Article 5 The production and sales and wholesale sales of prescription drugs, non -prescription drugs, and wholesale sales must be operated by pharmaceutical manufacturers and pharmaceutical wholesale enterprises with the "Pharmaceutical Production Enterprise License" and "Pharmaceutical Business Enterprise License". Article 6 Drug production and wholesale enterprises must use the principles of classification management, classification sales and regulations to sales prescriptions and non -prescription drugs of pharmaceutical retail enterprises and medical institutions with legal qualifications, and preserve sales records in accordance with relevant drug supervision and management regulations. Article 7 The prescription drugs and non -prescription drugs entering the field of pharmaceutical circulation shall be prominently printed on the drug packaging or pharmaceutical instructions by the production enterprise.
The corresponding warning or loyalty: as follows:
President medicine: Sell, purchase and use it with prescriptions of physicians!
The non -prescribed drugs, Class B non -prescription drugs: Please read the instruction manual carefully and use it under the instructions or buy and use under the guidance of the pharmacist! Article 8 Drug production and wholesale enterprises shall not directly recommend and sell prescription drugs to patients with sick patients in any way. Chapter III Pharmacy Retails Article 9 Sales Pharmaceutical Pharmaceuticals and Class A non -prescription retail pharmacies must have the "Drug Operating Enterprise License".
The retail pharmacies with sales prescription medicines and non -prescription medicines must be equipped with pharmacists or pharmacists above the store in the store.
"Pharmaceutical Business Enterprise License" and the practice pharmacist certificate should be hung in a prominent and easy place. Practice pharmacists wear brackets that indicate their names, technical titles, etc. Article 10 The prescription medicine must be sold, purchased and used for prescriptions with practicing physicians or practicing assistant physicians.
This pharmacist or pharmacist must review and sign the prescription and sell medicines according to the prescription after signing. Do not change or use the prescription without authorization. For prescriptions with compatible taboos or over -doses, the deployment and sales should be refused. If necessary, the prescription physician can correct or redesign it before it can be allocated and sold.
The retail pharmacy must be reserved for more than 2 years. Article 11 The prescription medicine shall not adopt the self -selected sales method. Article 12 Class A non -prescription drugs and type B non -prescription medicines may not be sold, purchased and used by doctors, but patients can require purchases and use under the guidance of Pharmacists or pharmacists.
This pharmacist or pharmacist should provide guidance for patients to purchase over -the -counter drugs or make suggestions for medical treatment for medical treatment. Article 13 prescription drugs and non -prescription medicine shall be placed in the cabinet. Article 14 Prescription drugs and non -prescription drugs shall not adopt sales methods such as award -winning sales, attached drugs or gift sales, and shall not be allowed to adopt online sales methods for the time being. Article 15 Retail pharmacies must procure prescription drugs and non -prescription drugs from pharmaceutical wholesale enterprises, pharmaceutical production enterprises with the "Drug Operation Enterprise License" and "Pharmaceutical Production Enterprise License", and preserve the procurement records in accordance with relevant drug supervision and management regulations. Chapter IV Medical Institution Candidate and Article 16 of the Prescription Drugs must be prescribed by practicing physicians or practicing assistant physicians. The prescription of doctors must follow the principles of science, reasonable, and economic, and medical institutions should establish a corresponding management system accordingly. Article 17 Medical institutions may use prescription drugs and non -prescription drugs in accordance with the needs of clinical and outpatient medical care in accordance with the provisions of laws and regulations. Article 18 Conditions of medical institutions and prescription drugs, procurement, and deployment of non -prescription drugs can be managed by retail pharmacies. Chapter 5 General Commercial Enterprise Retails Article 19 In areas with insufficient number of drug retail outlets and unreasonable layout, ordinary commercial enterprises can sell category B non -prescription drugs, but they must be reviewed, approved, registered by local local and municipal drug supervision and management departments at or above the local city level. , Eligible presence of category B non -prescription drug quasi -sales signs. The specific implementation measures are formulated by the provincial drug supervision and management department.
Cope, according to the principle of the people and the people, ordinary commercial enterprises selling type B non -prescription drugs should also be reasonably deployed.
In the encouragement and priority approval of the retail pharmacy with the "Drug Operation Enterprise License" cooperation with ordinary commercial enterprises to sell category B non -prescription drugs in ordinary commercial enterprises. Article 20 Ordinary commercial enterprises shall not sell prescription drugs and category A non -prescription drugs, and shall not adopt sales methods such as prize sales, accessible drugs or gift sales. Article 21 Class B non -prescription drug sales personnel and relevant managers of ordinary commercial enterprises must go through appropriate drug management laws, regulations and professional knowledge training, assessment, and certificates of drug management laws and regulations at or above the local city level. Article 22 When general commercial enterprises sell type B non -prescription drugs, special shelves or counters shall be set up, and medicines shall be placed in accordance with the provisions of laws and regulations.