Medical network - on December 20, shaanxi will since January 1, 2017 to carry out the material of two votes, one of the important contents of the New Deal is selected, the compression and distribution enterprise.

Urban public medical institutions through the bidding process, the selection and distribution enterprises, the choice of modern logistics enterprises, the compression number distribution companies, including three-level medical institutions consumables distribution enterprises shall not exceed 15; Secondary material distribution enterprise medical institutions is not more than 15.

The selection criteria?

Tongchuan city, shaanxi province health bureau sent a selection notice, which make clear a regulation, only in accordance with the delivery of certain condition (operation) enterprises to sign up to the public medical institutions at all levels. These conditions include: the enterprise registers fund 10 million, premises and warehousing area of not less than 200 square meters, cold storage is not less than 30 cubic meters, nearly three years have not substandard products, are not included in the record of pharmaceutical sales field of commercial bribery.

Only through these basic conditions set, many enterprises will be under the brush!

Attached: the shaanxi tongchuan city health family planning bureau about the open selection announcement of drugs and medical consumables distribution enterprises in the city of full text

Each related drugs, medical consumables distribution (business) :

To standardize city medical institutions and drug, medical consumables distribution work, improve the efficiency of distribution, delivery responsibility clear, guaranteed delivery, reduce the medical consumables inflated prices, according to the shaanxi province on the city public hospital comprehensive reform pilot guidance "(shaanxi province politics hair [2016] 38)," the shaanxi provincial medical consumables online sunlight procurement implementation plan "(shan wei medicine ZhengFa [2015] no. 175), the measures for the management of medical consumables online sunlight distribution work in Shanxi Province" (shan wei medicine ZhengFa [2016] no. 29) file spirit, the full implementation of medicines and chemical reagents, consumables "two votes", according to shan health hair [2016] no. 8 files "on deepening the reform of drug consumables supply security system of circular arrangement, combining the reality of our city, now open selection tongchuan city urban public medical institutions at all levels pharmaceutical, medical consumables distribution (operation) enterprise, will now matters related to notice the following:

A, scope of implementation

The city people's government at or above the county level and the state-owned enterprises at the non-profit medical institutions, the centers for disease control and prevention center, blood stations. Encourage other medical institutions on the medicines, medical consumables online purchase and unified distribution sunshine.

Second, the selection process

(a) by the municipal public health family planning to the province's public announcements selection, explicitly declare conditions, distribution (business) enterprise directly to the city public medical institutions for applications.

(2) the city selected the public medical institutions should set up a leading group, led by the main coalesced, members by medicament, YaoXie, clinical department personnel, equipment, etc. To open, fair, fair selection work.

(3) the city public medical institutions to review the selection of distribution enterprises, according to the application situation of three-level medical institutions and drug were no more than 15, consumables distribution enterprises; Secondary medical institutions and drug, consumables distribution enterprises respectively for no more than five and fifteen. Encourage medical consumables manufacturer direct distribution medical consumables for medical institutions, the number is not included in the distribution.

(4) urban public medical institutions will be the results to the municipal family planning bureau reported to the health, health and family planning will be the selection results in tongchuan city health information network for the public and public announcement.

Three, declare conditions

(a) drug

(2) medical consumables

1, enterprise declare conditions:

Selection and distribution (operation) only accept domestic medical consumables production enterprises and import medical consumables in shaanxi province general agent or declaration of tongchuan city general agent, do not set the general agent, only accept a declaration level agents, the agents acting area should be covered the whole city. The same import medical consumables can declare by a general agent, general agent products must have a power of attorney issued by the manufacturers abroad before filing. In the name of the group company to declare.

Declaration enterprise authorized only one natural person to attend the tongchuan city medical consumables distribution enterprise selection activities, and bear the corresponding legal responsibility. Group company wholly owned and holding subsidiaries according to different legal person business license jointly appoint a natural person as the authorized representative. Other natural person is allowed to represent a declaration for enterprises to participate in the medical consumables distribution selection activities.

2, application conditions:

(1) in accordance with the medical device manufacturing enterprise license or medical equipment business license and the business license of the tax registration certificate "organization code certificate" or "business license" three certificates and relevant qualification certificates, and at the provincial YaoXie centralized purchasing online registration.

(2) the enterprise registered capital of more than 10 million. Distribution enterprises has entered the tongchuan city hospital is preferred.

(3) medical consumables covering the city distribution transport ability (in principle not directly to the form of the logistics and distribution), the business premises and storage area of not less than 200 square meters (among them, the cold storage is not less than 30 cubic meters)

(4) since 2014, the declaration enterprise operated by any product at the location of the national and provincial medical instrument quality announcement or related file has more than twice (including twice) quality unqualified records, not to accept the enterprise declare.

(5) set up and standardize management, enterprise personnel, field and equipment in accordance with the medical equipment management quality management norms "(food and drug administration [2014] no. 58) requirements, guaranteed the basic condition of enterprise personnel, field and equipment, ensure the quality of enterprise management system, training assessment records of enterprises should be established according to their own actual real full traceability of the quality management registration record.

(6) since 2014, in production or business activities without produce fake medical consumables such as records of serious violation. Good reputation, has to perform the contract must have ability of medical consumables production scale and supply security. One to two years in shaanxi province pharmaceutical sales field of commercial bribery record two and five years and above in other provincial regional pharmaceutical sales field record production enterprises, commercial bribery will not accept the declaration.

(7) the applicant according to their own business qualification and scope of marketing in item 3 of this announcement procurement scope choose to sign up (up to three).

3, procurement scope

(1) high value medical consumables sunlight procurement directory includes: vascular interventional, orthopaedic implants, neurosurgery, ophthalmology, dental materials, extracorporeal circulation and blood purification, non vascular interventional, electrophysiology, pacemakers and other (patch, stapling, medical polymer materials, etc.) and other consumables.

(2) the ordinary medical consumables procurement sunshine directory includes: injection puncture instrument, medical health materials and dressings, medical consumables, anesthesia supplies, operating room commonly used medical X-ray accessories and parts.

(3) blood stations and blood Banks with consumables, test reagents, etc.

Four, the applicant shall submit the materials

(a) enterprise materials

1, a legal person authorization (import medical consumables declaration enterprise shall submit agency agreement or the general agent certificate) issued by foreign manufacturers.

2, application report.

3, apply for medical consumables distribution enterprise basic information registration form.

4, apply for drug distribution enterprise basic information registration form.

5, qualification certification documents: the pharmaceutical trade license, the pharmaceutical management quality management certification certificate "; The medical device manufacturing enterprise license or medical equipment business license, the business license, tax registration certificate, organization code certificate "or" business license "(the joining together of three certificates) and related certificates.

6, operating data: 2014 and 2015 annual financial statements of the enterprise, medical consumables sales total amount (annual sales amount), balance sheet, income statement, and other relevant tax statements can prove the enterprise operating performance data.

7, basic facilities information: corporate offices, business premises, warehouse (including cold storage) and lease contract of property rights, the places of plane layout diagram and related facilities equipment list.

8, data quality management system: quality management files, the enterprise staff roster (including education, job title, position, working years, etc), head of enterprises, quality management personnel, title certificate, qualification certificate, etc.

9, computer information management systems: a perfect function of computer information management system certificate and descriptive information.

10, the good faith management, and social contribution certificate: enterprise local tax, drug safety, price and other related issued by the administrative law enforcement to the last three years no record of illegal proof.

11, application promises material matters: the truthfulness of the application materials guarantee statement, distribution service commitments.

12, legal representative identity certificate or authorization by the legal representative and the person in charge.

(2) the product material

1, declare enterprise management product summary table;

2, the medical device registration certificate and manufacturing approval table or the registration form and the attached; Registration certificate expired shall provide a new license or acceptance letter and other documents;

(3) the material description

Declare data must be in accordance with the relevant completion instructions, and meet the following requirements:

1, all filing materials provided information must be true and effective, conform to the requirements, especially given the information such as the production enterprise to consistent with the original certification, all valid certificates should be paid attention to.

2, the production management enterprise to submit all documentation and correspondence letter use Chinese, foreign language documents must provide the corresponding Chinese translation notarized, authenticity, legitimacy shall be the responsibility of the enterprise.

When applying for 3, provide the paper material, should meet the following requirements:

(1) to submit data unified use A4 paper.

(2) to submit the material should be page build official seal of the unit.

4, not on time, in accordance with the provisions, submit enterprise or product information, according to the enterprise automatic give up treatment.

All these prove that all needs to provide the original and copy of sexual file. (the original return after review)

Five, the application materials submitted to the above dates

In December 2016, 12 solstice 17:30pm on December 23, 2016

Six, after examination, by the selection of enterprise, the distribution of medicines, medical consumables prices will be in accordance with the requirements for the health related, by the expert group on the basis of the current pricing or the market price for price negotiations.