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"4+7" Urban Drug Collection Regulations for Published: Based on Consistency Evaluation
Release time: 2018-11-06 & nbsp & nbsp & nbsp Source: Anonymous

Recently,Agree with the National Medical Insurance Bureau,"4+7 Urban Pharmaceutical Medical Purchasing Documents" is officially released on Shanghai Sunshine Pharmaceutical Purchasing Network。

File name,With the consent of the comprehensive deepening reform committee through the Central Committee,National Organized Drug Concentrated Purchasing Pilot,The scope of the pilot area is Beijing、Tianjin、Shanghai、Chongqing and Shenyang、Dalian、Xiamen、Guangzhou、Shenzhen、Chengdu、Xi'an 11 cities (hereinafter referred to as 4+7 cities)。Pilot regional appointment representatives to form a joint procurement office (hereinafter referred to as Liancai Office) as a work agency,On behalf of the pilot area, public medical institutions implement centralized procurement,Daily work and specific implementation shall be borne by Shanghai Medical Stake Sports BettingCentral stake sports betting appBidding Procurement Affairs Office。The centralized procurement of some drugs and related services in pilot regions of public medical institutions is launched,Please come to report。

file representation,Procurement varieties (specified specifications) and agreed purchasing volume,It is based on the appraisal of the consistency evaluation catalog of the quality and efficacy of the imitation drugs and the "State Food and Drug Administration on the release of chemical drug registration and classification reform work plan". [No. 51, 2016] Fixed of the Catalog of Micro Drugs and Classification of New Chemical Drugs。

Just the day before the file hanging network,The Fifth Meeting of the Central Comprehensive Deepening Reform Commission was held,"Pilot Plan for the National Organization Drug Concentration Procurement" was reviewed and approved。

 

Meeting to point out,National Organized Drug Concentrated Purchasing Pilot,The purpose is to explore and improve the centralized pharmaceutical procurement mechanism and the market -oriented drug price formation mechanism,Reduce the burden of mass costs for the masses,Standardize the order of drug circulation,Improve the safety of the masses for medication。According to national organization、Alliance purchases、The overall idea of ​​the platform operation,Persist in compliance according to law,Adhere to the combination of market mechanism and government role,Make sure the quality of medicine and supply stable。

According to the file,31 varieties of the first batch of purchase directory。Where,Clopidogreid Orally Interpretation Frequent Dalog Procurement Volume 2938 million tablets、Atropine's Oral Oral Automators 20mg Purchase of 156.7 stake sports betting appstake online sports bettingmillion tablets、Clopidogreid Orally Activating Rescue 25mg purchasing volume of 183.2 million tablets,average of over 100 million。

Declaration rules

Enterprises and specifications that obtain pre -selected qualifications,Uniformly enter the confirmation procedure of bargaining negotiations。

1. The number of enterprises that meet the application conditions ≥ 3 varieties: pre -selected varieties declaration price meets the relevant requirements of this quotation,After confirming the two parties,Get the qualification to be selected。

2. Number of enterprises that meet the application conditions ≤ 2 varieties: ① The pre -selected variety declaration price decline ranks among the top (not more than 7),After confirming the confirmation of both parties, they are qualified for the selection;。The declared price meets the requirements of the decline and reached an agreement,You can get qualifications to be selected。If you do not participate or accept bargaining negotiations,This variety is treated as a liquidity treatment,It will affect the centralized procurement of drugs involved in the pilot area。(The decline is based on the minimum purchase price of the pilot area at the end of 2017)。

Declaration Qualification

Application Enterprise: refers to domestic drug manufacturers that provide drugs and accompanying services,Imported drugs Domestic general agent business as the same manufacturer。

Application enterprises to participate in drug centralized procurement activities shall have the following conditions:

1. The ability that must be possessed with the performance of the contract;

2. Participate in this centralized procurement activity,No serious illegal records in drug production activities;

3. It must be responsible for the quality of the medicine,My stake betting appTimely、Full amount of Stake Sports Bettingproduction according to the requirements of Liancie Office,and send medicines to the distribution company。

Application enterprises shall prepare the application materials in accordance with the requirements of the procurement documents,Reporting materials to respond to the requirements and conditions of the purchase documents in response to the purchase documents。

Declaration varieties

refers to the listing drugs that have been registered for effective approval within the scope of the catalog of the procurement variety。

Declaration requirements

1. The application for the annual production and sales of the enterprise commitment to apply for the annual production and sales capacity reaches the requirements for the number of procurement。

2. Declaration variety is a catalog range of procurement varieties,Meet one of the following requirements:

 

 

(1) Original Drug and State Drug Administration The quality and efficacy consistency evaluation preparation released by the State Drug Administration。

(2) Imitation drugs that are evaluated by the quality and efficacy of imitation drugs through the State Drug Administration。

(3) According to the "Announcement of the State Food and Drug Administration on the Reform of the Reform of the Reform of Chemistry Drugs" [2016 No. 51],Imitation drugs approved by the new registered classification of chemicals。

3. Enterprise has effective registration approval of the specifications specified in this procurement variety,When applying for varieties,Each variety must include all the main products produced by the company。

The pharmaceutical industry will be shuffled

The volume procurement promoted by the State Medical Insurance Bureau can be understood as a centralized procurement stake betting appfor drugs in the "country".,The purpose is to "change stake betting appthe price with quantity"。"Change the price" means,The purchase of this time will be 60%-70%of the total annual medication in all public medical institutions in the pilot area,Switching through consistency evaluation products and the minimum quotation of the original research products。

According to the file regulations,Not only these 60%-70%markets,The remaining 30%-40%markets and unscrupulous products will also be affected,Because if the price of the bid in winning with the volume is too large,Other prices also need to be adjusted。