National adjustment of the distribution of fine pharmaceutical circulation industry

On December 18, the State Food and Drug Administration stated that in order to adapt to the changes in the total market demand for narcotic drugs and the first type of psychotropic drugs (hereinafter abbreviated as Ma Jing drugs), the first adjustment after the macro layout in 2006 will be carried out. Re-distribution of enterprises with a large number of scattered operations and regional wholesales, annual average consumption of sesame-type drugs (calculated by the amount of medical institutions purchased) in the past three years is more than 10 million yuan (inclusive), and the permanent population is 5 million. (More than), can set up no more than three regional wholesale companies.

Zhao Zhen, an analyst in the pharmaceutical industry, believes that this adjustment is aimed at the adjustment policy of the pharmaceutical distribution industry and will promote the improvement of the profits of high-quality linen drug companies.

Re-adjust the layout

It is reported that this layout requires the city-level administrative region of the district as the unit. The annual average consumption of Maquinine drugs (calculated by the purchase amount of medical institutions) is more than 10 million yuan (inclusive) and the permanent population is 500. More than 10,000 (inclusive), can set up no more than 3 regional wholesale companies; annual average consumption of 5 million yuan (inclusive) and more than 10 million yuan, or average annual consumption of more than 10 million yuan, but the permanent population of less than 500 Ten thousand, can set up no more than two.

According to the State Food and Drug Administration, no more than one city is required to be established in other cities with districts; for transportation facilities, other regional wholesale companies within the administrative area of ​​the province (region, city) can securely deliver and guarantee supply, it may not be established. Regional wholesale companies. Among them, Beijing, Tianjin and Shanghai can set up no more than 3 regional wholesale companies; Chongqing does not have more than 16 cities, including no more than 2 urban areas. For regions where it is difficult to ensure the demand for medical institutions to use drugs due to special reasons such as long distribution radius or inconvenient traffic, the SFDA added that provincial food and drug regulatory authorities may appropriately establish regional wholesale enterprises according to the actual situation.

The State Food and Drug Administration stressed that the adjustment of regional wholesale enterprises should be completed by June 30, 2013. If an existing regional wholesale enterprise fails to obtain fixed-point operation qualification after adjustment, it shall not operate narcotic drugs and psychoactive drugs of the first category. The inventory narcotic drugs and the first-class psychoactive drugs shall be handled in accordance with relevant regulations. Each provincial drug regulatory agency shall The list of regional wholesale enterprises within the administrative area shall be submitted to the State Administration of Administration for the record.

Preferred point of operation

The State Food and Drug Administration stated that it will jointly supervise the local drug administration department and make comprehensive assessments according to the indicators such as business scale, quality management level, market share, and service scope of the reporting company, and that enterprises that meet the criteria for granting fixed points should follow the principle of narcotic drugs and spirit. In accordance with the provisions of the Measures for the Administration of Pharmaceuticals (Trial Implementation), the designated enterprises shall be determined on the basis of merit determination. Among them, companies with more than five years of experience in the administration of narcotic drugs and the first type of psychotropic drugs are given priority under the same conditions. The company's total annual sales of drugs, total profits and taxes, and asset-liability ratios are also given top priority in the cities where they are located.

However, the State Food and Drug Administration also pointed out that enterprises that have one of the following circumstances will not be designated: enterprises and staff members have violated the anti-drug laws and regulations in the past two years; enterprises have been violated by relevant regulations in the past five years. The drug regulatory department cancels the qualification of the regional wholesale enterprise; the existing regional wholesale enterprise does not guarantee the supply of anesthetic drugs and the first type of psychoactive drugs in the drug-responsibility area.

Conduct safety assessment

Zhao Zhen pointed out that the layout is of great significance. However, in the later implementation process, the construction of the safety evaluation mechanism must also keep up. This includes two aspects. First, it involves the use of illegal means to apply ephedrine drugs for the manufacture of drugs. In the establishment of a late-stage safety assessment mechanism, it is necessary to formulate a detailed tracking and verification system for the flow of fine chemicals. Effectively prevent fraudulent purchases, arbitrage and other acts; second is the patient's drug safety assessment, involving the rationality of drug use and drug types, the use of new and old ephedrine drugs, the need to further explore the feasible and standardized applicable standards .

The State Food and Drug Administration stated that after the adjustment of the layout is announced, the implementation of the safety system will be periodically reviewed in the later period, and the safety facilities and equipment will be inspected, maintained, maintained and verified. The specialized narcotic drugs and the first class of psychoactive drugs will be set up. The special library shall meet the requirements for the storage of Mashu drugs, fire prevention facilities, monitoring facilities and alarm devices shall be installed, alarm devices shall be networked with the alarm system of the public security organs, and a special library management system shall be established. The State Food and Drug Administration also requires that the enterprises incorporated into the layout should have the conditions for the distribution of narcotic drugs and the first type of psychotropic drugs to the medical institutions in the corresponding regions, and comply with the state's regulations on transportation.