The following is a more detailed answer:
First, the conditions of drug distribution enterprises and selected
(a) distribution conditions.
Undertake rural drug distribution work of the drug business enterprises should have the following conditions:
1, has obtained the "Drug Business License", and through the "Drug Business Quality Management Standard" certification of the pharmaceutical wholesale enterprises;
2, three years without operating counterfeit drugs, substandard drugs, have a good record of good faith;
3, in accordance with the relevant provisions of the Drug Purchase and Distribution In accordance with the provisions of the relevant drug procurement and distribution, with appropriate conditions for drug distribution (i.e., must have a fixed place, special distribution vehicles, and storage of medicines compatible with the sanitary environment, equipment and facilities, as well as a certain number of distribution staff), the varieties of medicines and the scale of the business to meet the needs of rural health care institutions, drug retailers in the demand for medicines; distribution of distribution centers set up outside of the approved registered address (station) pharmacy should be in line with the GSP requirements, and passed the GSP certification inspection. Requirements, and through the GSP certification inspection;
4, a strong distribution base, with the county (district, city) within the jurisdiction of the rural drug retailers, rural medical institutions to provide quality and affordable medicines, one-time use of sterile medical devices and the ability to provide distribution services; the distribution of medicines to be able to deliver the time limit specified in the agreement;
5, the development of a corresponding distribution management system
6, to undertake the centralized distribution of rural drugs should have other conditions.
(B) declaration procedures.
All have the above conditions of the city inside and outside the pharmaceutical wholesale enterprises, can apply for the city's rural drug distribution enterprises recognized. Apply for recognition of rural drug distribution of pharmaceutical wholesale enterprises should be located in the county (district, city) Food and Drug Administration to apply, and submit the following information (in triplicate):
1, the recognition of rural drug distribution enterprises to apply for a report on the establishment of distribution centers (stations), as well as the distribution of services to ensure that the measures;
2, "Drug License", "business license" and "Drug Quality Management Standard".
2, "Drug Business License", "Business License" and "Drug Business Quality Management Standard Certification" copy (stamped with the official seal of the enterprise);
3, signed rural drug distribution agreement and rural drug supply point roster;
4, rural drug distribution management system;
5, other relevant information to be provided.
(C) Qualification.
1, apply for drug distribution enterprises, the enterprise's county (district, city) Food and Drug Administration is responsible for acceptance. By the county (district, city) Food and Drug Administration organization on the application of the distribution of enterprises in the past three years and the quality of drug management to carry out a comprehensive assessment of qualified, formally determine the scope of the enterprise in the provisions of the rural drug distribution business, and reported to the Jiuquan City Food and Drug Administration for the record.
2, formally confirmed to undertake the distribution of rural drug supply network of the main enterprise, should fill out the "Jiuquan City, rural drug supply network distribution enterprise record registration form" (Attachment 1), "Jiuquan City, rural drug supply network distribution enterprise operator record registration form" (Attachment 2), "Jiuquan City, rural drug supply network distribution network registration" (Attachment 3), "Jiuquan City, rural drug supply network distribution network summary form" (Attachment 4) Network Distribution Network Summary Table" (Exhibit 4), of which Exhibit 1, 2, 4 reported to the City Council for review and filing.
3, to determine the distribution of a distribution enterprise distribution cycle for 1 year, 60 days before the expiration of the re-examination to determine.
4, the counties (districts, cities) Food and Drug Administration and the distribution of the main business signed one by one, "the quality and safety of rural drug distribution responsibility," and coordinate the implementation of drug distribution of the main business and distribution outlets to sign the "distribution of drug quality and safety agreement. Distribution outlets to produce and hang a unified format of the supervision of the express convention (see Annex 5).
5, in the distribution contract validity period, distribution companies need to withdraw from the distribution for their own reasons, should be 60 days in advance to notify the county (district, city) Food and Drug Administration, Food and Drug Administration from the date of receipt of the written notice should be re-organized to determine the distribution of enterprises within 60 days. In the original contract before the termination of the original distribution company should still be contracted to fulfill the distribution obligations.
Second, the principles and requirements of drug distribution
(a) the principle of drug distribution.
1, the principle of qualified drug quality. Distribution companies must give the drug distribution outlets to provide quality qualified drugs, while taking the initiative to provide the relevant proof of qualification. Due to the distribution of pharmaceutical quality problems caused by the enterprise, the responsibility is borne entirely by the distribution of enterprises. Conditional distribution enterprises can be in the distribution of drug packaging affixed with anti-counterfeiting logo or special distribution logo to ensure the quality of drug distribution.
2, the principle of reasonable price of drugs. Distribution enterprises should refer to the market supply price, taking into account the purchase cost, distribution costs, supply quantity and payment commitment and other factors to determine the price of drugs. Drug prices should be kept at a lower level in the city market.
3, the principle of complete varieties of drugs. Distribution of enterprises to meet the basic needs of drug supply outlets on the varieties of varieties, the number of varieties (including origin, specifications) in principle shall not be less than 95% of the varieties should be distributed.
4, quality of service principle. Distribution enterprises in the process of drug distribution, should be timely, accurate, thoughtful, convenient, enthusiastic, shall not be delayed, difficult customers, cumbersome procedures, cold customers, the implementation of "one-stop" service.
(B) the requirements of drug distribution.
1, the distribution companies to strengthen the implementation of business quality management standards, the establishment of distribution network qualification files, improve the distribution contract, standardize the distribution process of drugs, strict compliance with the quality assurance commitment and the refusal of commercial bribery commitment to the implementation of standardized distribution, integrity and quality service.
2, distribution companies should establish and improve the internal operation mechanism in line with the needs of drug distribution. Drugs should be established from the invoice to pick up, delivery, "one-stop" service operation mechanism; to take appropriate measures to maximize customer convenience.
3, the distribution of drugs should be strictly distribution of varieties and quality, the quality of the distribution of drugs should be in line with the "Chinese People's *** and the State Pharmacopoeia" or the national drug supervision and management department of the standards. It is strictly prohibited to supply drugs beyond the scope, and strictly prohibited to distribute drugs to units and individuals without the qualification of drug use and operation.
4, was identified as the city's rural drug distribution enterprises are mainly responsible for the jurisdiction of the rural drug business enterprises and medical institutions of the distribution of drugs, is the jurisdiction of the rural drug distribution of the main channels, the distribution of enterprises should be strictly fulfill the service commitment, in strict accordance with the distribution agreement distribution of drugs.
5, distribution enterprises should receive the purchase of drugs plan, according to the specified time quality and quantity of drugs delivered to the designated location, shall not be refused on any pretext to the purchase of a small number of or remote places to distribute.
6. Distribution companies should provide timely information on the price of new products and accompanying services as agreed in the contract.
Third, supervision and management
(a) the townships and townships under the jurisdiction of the city according to law to obtain licenses, permits, pharmaceutical retail enterprises, medical institutions operating and using the medicines and equipment in principle should be determined by the local food and drug supervision and management department of the centralized distribution of pharmaceutical enterprises or the implementation of centralized bidding and purchasing. Chemical preparations, antibiotic preparations, proprietary Chinese medicines and Chinese medicinal tablets, and single-use sterile medical devices used by drug retail enterprises and medical institutions in townships and townships below should be included in the scope of centralized distribution. The supply of prophylactic biological products, blood products, and specially administered drugs is carried out in accordance with the provisions of laws, rules and regulations.
(B) distribution contract validity, distribution companies have one of the following circumstances, the local food and drug supervision and management department to investigate and verify the qualification of its distribution, and the organization to determine the new distribution company.
1, by the relevant departments to revoke their licenses, permits;
2, the intentional sale of counterfeit, inferior drugs are investigated and dealt with according to law;
3, the intentional sale of unlicensed or do not meet the national standards for single-use sterile medical devices are investigated and dealt with according to law;
4, has been incapable of fulfilling the obligation of distribution or distribution obligations are not fulfilled in accordance with the contract, which has led to serious consequences
5, the year-end evaluation results for the "unqualified";
6, the integrity of the evaluation for the serious bad business or other serious violations, has been unsuitable to continue to undertake the centralized distribution of rural drugs.
(C) rural drug retail enterprises and medical institutions shall not have the following behaviors:
1, refused to participate in the centralized distribution of rural pharmaceuticals without justifiable reasons;
2, in the name of charging consulting fees, sponsorships, promotional fees, etc., directly or indirectly relative to the distribution of the distribution of enterprises to carry out the distribution;
3, in the distribution of enterprises in accordance with the provisions of this regulation and the distribution of the contract requirements to perform distribution In the case of distribution enterprises in accordance with these provisions and the distribution contract requirements to fulfill the distribution obligations, but still from other channels to purchase drugs and sterile medical devices for single use products or refused to accept the origin does not match the reason;
4, to intentionally default on payment, return and exchange of goods and other forms of difficult distribution enterprises.
(D) the counties (cities, districts) Food and Drug Administration should obtain the main qualification of rural drug distribution of pharmaceutical wholesalers to carry out an annual assessment, the results of the assessment will be used as the next year to determine the distribution of an important basis for the enterprise. At the same time, practical measures should be taken to strengthen the distribution enterprises, rural drug retail enterprises and medical institutions of drug quality supervision and management, the full implementation of drug purchase and acceptance, request for certificates and tickets and drug quality commitment and other standardized management measures, and strive to achieve the distribution of the source to the retail terminal of the integrated management of drug safety. At the same time, to strengthen the distribution of enterprises and rural medical institutions, drug companies to publicize and training, and effectively enhance the drug unit as the quality of drugs "first person responsible for" the awareness of responsibility, to ensure that the majority of farmers with safe and effective medication.