4 + 7 detailed rules for centralized drug purchase in cities

On November 21, Shanghai Sunshine pharmaceutical purchase network released the supplementary documents of 4 + 7 city drug centralized purchase in Shanghai area, which made clear the detailed rules of drug distribution, quality inspection, payment for goods, and the use of winning and unsuccessful varieties The following is the full text of the announcement: declaration enterprises: According to the "4 + 7 urban drug centralized procurement document" issued by the joint procurement office, in order to implement the procurement of selected drugs in Shanghai, the Shanghai Pharmaceutical Centralized Bidding Procurement Management Office (hereinafter referred to as "the working agency") issued supplementary documents on the application of enterprises in Shanghai, drug distribution, quality testing, tripartite agreement, payment for goods, use of selected drugs, etc The details are as follows: 1 In principle, the drugs declared by the enterprise to be supplied according to the purchased varieties should be commonly used in clinical packaging, and it is encouraged to provide drugs that meet the requirements of more than two weeks' dosage packaging for chronic diseases 2 Drug distribution 2.1 the implementation of the requirements for centralized drug purchase in 4 + 7 cities in this city follows the principle that only one drug distribution enterprise is entrusted to be responsible for the distribution of a selected variety When applying for the "application materials" for centralized drug purchase in 4 + 7 cities, the enterprise shall submit the agreement of intent for distribution in Shanghai (Annex 1) signed by both the application variety and the designated distribution enterprise, The distribution intent agreement shall not violate the requirements of "4 + 7 urban drug centralized procurement document" 2.1.1 the declaration enterprise shall put the signed agreement of intent for distribution in Shanghai into the envelope and mark the words "Shanghai supplementary document" on the envelope The seal shall be sealed with the official seal of the enterprise or signed by the authorized person 2.1.2 the applicant shall put the envelope of Shanghai supplementary document into the "application materials" for centralized procurement of 4 + 7 urban drugs 2.2 the designated distribution enterprises shall meet the following conditions: (1) the scope of drugs distributed by the designated distribution enterprises in 2017 covers all districts of the city; (2) the designated distribution enterprises shall have the ability and conditions to distribute the selected drugs to the designated medical institutions of the city's medical insurance within 24 hours 2.3 as a drug distribution enterprise undertaking distribution obligations, it is not allowed to purchase the selected drugs through a third party Those who fail to fulfill the above obligations shall be disqualified from distribution once confirmed and punished according to regulations 3 Quality inspection 3.1 the work organization will investigate the drug production and quality of the selected drugs of the selected enterprises (the investigation form shall be determined according to the actual situation), and the selected enterprises shall actively cooperate 3.2 in order to ensure the stability and consistency of the quality of the selected drugs before and after the selection, if the drugs declared by the declaration enterprise are selected, they must be subject to the monitoring of each batch of the selected drugs supplied by the working agency by using near-infrared spectrum modeling and other detection methods 3.3 if the drugs declared by the declaring enterprise are selected, they must be subject to sampling inspection at least twice a year and flight inspection if necessary 4 Tripartite agreement 4.1 after the declaration enterprise is selected, the working organization, the selected enterprise and the designated distribution enterprise will sign the tripartite agreement (Annex 2) 4.2 the settlement of purchase price for the 4 + 7 city centralized purchase of selected drugs in Shanghai shall be carried out in accordance with the settlement method agreed in the tripartite agreement, and the selected production enterprises shall pay the drug distribution expenses to the distribution enterprises in accordance with the tripartite agreement, and shall not be in arrears 4.3 in the performance agreement of the selected drugs, in case of national policy adjustment or force majeure, which directly affects the performance of the agreement, the three parties in the three party agreement shall negotiate to solve the problem 5 Payment for goods 5.1 the working organization and the designated distribution enterprise shall set up a special fund account 5.2 the working organization shall pay the payment for the selected products to the special account of the designated distribution enterprise in three times: 5.2.1 within 5 working days after signing the tripartite agreement on the purchase and sale of the selected products in the centralized purchase of drugs, the working organization shall pay 50% of the total payment to the designated distribution enterprise; 5.2.2 Half a year after the implementation of the procurement cycle or when the procurement volume reaches 50% of the agreed procurement volume, the working agency shall pay 45% of the total payment to the designated distribution enterprise; 5.2.3 at the end of the agreed supply period, the working agency shall clear the payment for goods of the designated distribution enterprise and pay the remaining payment after the completion of the clearing 6 For the selected varieties, 6.1 all designated medical institutions of medical insurance in this city (hereinafter referred to as "medical institutions") shall give priority to purchasing and using the selected drugs in 4 + 7 cities, and the amount of use shall be equivalent to the level of the previous year in principle 6.2 the use of selected drugs by medical institutions shall be deemed to meet the requirements of "one product, two regulations" according to the regulations of relevant departments of this Municipality 7 Use of unselected varieties 7.1 medical institutions can continue to purchase and use unselected drugs on the premise of ensuring the dosage of the selected varieties, but the quantity shall not exceed the selected varieties after conversion according to the proportion relationship Seven point two The highest price drugs of the same variety that are not selected according to the requirements of this centralized purchase declaration must be purchased and used on the basis of the 2017 bidding price (or online price) of the city, and the gradient price reduction can be realized according to the price difference (based on the bottom price of the selected price) The larger price difference must be further increased by a large price reduction range The actual purchase price shall be confirmed by the production enterprises and medical institutions through online public price negotiation Fixed 7.3 for the non selected non highest priced drugs of the same variety that meet the requirements of this centralized purchase declaration, the online price shall not be higher than the online price of the highest priced drugs adjusted according to the requirements of 7.2 The actual purchase price shall be determined by the production enterprise and medical institution through the online public bargaining purchase 7.4 if there are more than (including) 3 manufacturers of generic drugs of the same variety that meet the requirements of this centralized purchase declaration, they will no longer purchase other manufacturers of the same variety that do not meet the requirements of this centralized purchase declaration If there are no more than (excluding) 3 manufacturers of generic drugs of the same variety that meet the requirements of this centralized purchase declaration, other products that do not meet the requirements of this centralized purchase declaration, but have won the bid (or have been linked to the network) in this city can continue to be purchased and used, and the linked price shall be lower than the selected price, and the actual purchase price shall be determined by the manufacturers and medical institutions through the open price negotiation through the linked network 8 The final interpretation right of this document belongs to Shanghai Pharmaceutical centralized bidding and purchasing affairs management office.