Lanzhou City, drugs and medical devices practice supervision and management measures

Article 1 In order to strengthen the drugs, medical devices (hereinafter referred to as medicines and equipment) practice management, standardize the practice of units, personnel behavior, to ensure that the public use of medicines and equipment safety, in accordance with the "Chinese People's Republic of China * * * and the State Drug Administration Law", "Chinese People's Republic of China * * * and the implementation of the Regulations of the Drug Administration Law" and "Medical Devices Supervision and Administration Ordinance," and other laws and regulations, the combination of the actual situation of the city, to formulate the present approach. Article 2 The administrative area of the city and the production, operation, use of pharmaceutical and equipment activities and supervision and management of the relevant units or individuals, shall comply with these measures.?

Laws and regulations provide otherwise, from its provisions.

The measures referred to in the production, operation and use of medicines and equipment and supervision and management of the relevant units or individuals include:?

(a) pharmaceutical production enterprises and their employees;?

(B) pharmaceutical wholesale and retail enterprises and their employees;?

(C) medical institutions and other pharmaceutical equipment use units and their employees;?

(4) municipal, county and district food and drug supervision and management departments (hereinafter referred to as the drug supervision department), supervision and inspection agencies and their staff.? Article III of the municipal drug supervision department in charge of the supervision and management of the city's pharmaceutical industry.

Industry and commerce, quality and technical supervision, taxation, health, price, labor security, family planning, investment and other administrative departments should be in their respective areas of responsibility, to do a good job of supervision and management of the pharmaceutical industry. Article IV engaged in the production, operation and use of medicines and equipment units and individuals, should strictly abide by national laws, regulations, rules and regulations and relevant industry norms.

Engaged in the production, operation and use of pharmaceutical equipment units and individuals, should be responsible for its production, operation and use of pharmaceutical equipment quality.

Engaged in the production, operation, use of pharmaceuticals and equipment units and individuals, should follow the principle of fairness, integrity, honesty and credit, standardized operation, civilized practice, shall not harm the legitimate rights and interests of consumers, shall not damage the interests of the public ****. Article 5 The Pharmaceutical Industry Association shall play a supervisory, coordinating and service role, strengthen industry self-discipline, standardize industry behavior, and maintain the rights and interests of association members and industry order; to strengthen the popularization of public health knowledge, publicity, and guide consumers to choose the legal production and operation of operators to produce, operate and use of medicinal products, as well as medicinal products with legitimate marking.? Article 6 encourages citizens, legal persons and other organizations to implement social supervision of the practice of medicines and devices. Violation of these measures, any unit or individual has the right to report to the drug supervision department.

Pharmacological supervision department shall publish the department's e-mail address or telephone number; report received, should be timely and complete records, properly preserved and confidentiality for the informant. Reported matters belonging to the department's responsibilities, should be accepted, and verification, processing, response according to law; does not belong to the department's responsibilities, it should be forwarded to the department entitled to deal with the department and inform the informer. Article VII of pharmaceutical production, management and use of quality management and drug testing units should have a pharmacy and other related professional qualifications, or with a technical title in pharmacy, after professional training and by the municipal drug supervision department after passing the examination and licensing. Article VIII of pharmaceutical production, operation and use of drug testing organizations or personnel, should be subject to the municipal drug supervision department set up by the drug testing agency business guidance. Article IX of pharmaceutical production, operation and use of units engaged in acceptance, maintenance, measurement, storage, sales and other personnel should have the appropriate education or a certain level of literacy, professional training and by the municipal drug supervision department after passing the examination and licensed. The state has employment access provisions of the post, the staff shall pass the vocational skills assessment and obtain professional qualification certificate before taking up the post.? Article 10 of the pharmaceutical production, operation and use of units should be carried out on its staff for pharmaceutical-related laws, regulations and professional knowledge training, the establishment of training files, training files should be recorded in the training time, place, content and the personnel trained.

Municipal drug supervision departments should be engaged in the purchase and sale of drugs, medical equipment products and related work each year for the continuing education of laws, regulations and professional knowledge.

Pharmaceutical retail enterprises operating Class B non-prescription drugs shall be equipped with business personnel qualified by the municipal drug supervision department organization assessment.?

Violation of the provisions of this Article, the city, county, district drug supervision department shall give a warning and order rectification within a specified period of time; if no rectification is made after the expiration of the period of time, it shall be ordered to suspend production and business rectification, and shall be subject to a fine of more than 2,000 yuan and less than 20,000 yuan.? Article XI of the pharmaceutical production, operation and use of units should strengthen the management of pharmaceutical practitioners, and make specific provisions for their practice behavior.

Pharmaceutical production, operation and use of units and their practitioners shall not have the following behavior:?

(a) intentionally mislead consumers to buy more drugs than needed, resulting in drug abuse;?

(2) intentionally exaggerate the efficacy of medicines and devices, and promote medicines and devices for profit;

(3) using tie-in sales, buy medicines and devices, buy goods and devices to the public in the form of prescription drugs or non-prescription drugs of Class A, medical devices;

(4) using mail sales, Internet transactions, and other means of direct sales of prescription drugs to the public; and

(4) using the Internet to the public in the form of prescription drugs;?

(e) the sale of prescription drugs without a prescription;?

(F) the sale of high-risk implantable medical devices to individuals;?

(vii) Facilitating conditions for practitioners to engage in illegal activities of medicines and devices within or in the name of the organization.?

Violation of the provisions of this article, by the city, county, district drug supervision departments of the production, operation and use of pharmaceutical equipment units to give a warning, ordered to make corrections, and impose a fine of 3,000 yuan or more than 30,000 yuan.?