Anesthesia, psychotics, these special drugs production and sales within 7 days to report
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Last Update: 2021-02-05
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Source: Internet
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Author: User
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The State Drug Administration issued the Notice on the Official Operation of the Information Reporting System on the Production and Circulation of Special Drugs, requiring pharmaceutical manufacturers of narcotic drugs, psychotic drugs and pharmaceutical-type easy-to-make chemicals to report them within 7 days of the occurrence of production and business activities. Violations of laws and regulations such as illegal sales, forged qualifications and fraudulent purchase of special drugs shall be severely investigated and punished in accordance with the law.
In 2016, the former State Administration of Food and Drug Administration issued a document to organize and develop an information reporting system for the production and circulation of special drugs (hereinafter referred to as the Special Drug Information Reporting System) in accordance with the relevant requirements of the Regulations on the Administration of Narcotic Drugs and Psychotic Drugs, the Regulations on the Administration of Easy-to-Drug Chemical Drugs and the Measures for the Administration of Drug-type Easy-to-Drug Chemical Drugs. The detailed data on the production, circulation and stockpile of narcotic drugs, psychotic drugs and pharmaceutical-type easy-to-use chemicals are queried and counted, the implementation of the specialty drug production plan and purchase plan is monitored, and the nationwide trial operation will be carried out from January 2017.
The State Drug Administration said in a notice issued recently that the special drug information reporting system has been put into operation for two years, and all the work has been carried out smoothly. June 2018 special drug information reporting system construction through the expert meeting acceptance, the system has been officially operational. In order to strengthen the application of the special drug information reporting system, the relevant requirements are heeded as follows:
1. Special drug production and operation enterprises shall, within 7 days after the occurrence of production and business activities, fill in or import data the details of the purchase, production and sale of API and preparations in the special drug information reporting system in accordance with the method of each variety, specification and batch. If there is a change in the registration information of the enterprise, it shall be reported to the provincial drug supervision and administration department for examination and approval after the modification in the system.
, the provincial drug supervision and administration departments to regularly review the system of enterprise reporting information, found that the enterprise report information is incomplete and inaccurate, urge enterprises to correct in a timely manner.
, provincial drug supervision and administration departments should take the initiative to use the special drug information reporting system query, statistical functions, regularly check the special drug information data. To carry out timely investigation and verification of suspicious circumstances, and to severely investigate and punish any illegal or illegal acts found, such as illegal sales, forged qualifications and fraudulent purchase of special drugs.
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