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    Home > Medical News > Latest Medical News > These two kinds of new drugs can be directly linked to the Internet, and enterprises with five major behaviors cannot declare them

    These two kinds of new drugs can be directly linked to the Internet, and enterprises with five major behaviors cannot declare them

    • Last Update: 2019-02-15
    • Source: Internet
    • Author: User
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    Notice to manufacturers on carrying out direct online procurement of new drug varieties: According to the opinions of the general office of the CPC Central Committee and the general office of the State Council on deepening the reform of the review and approval system and encouraging the innovation of drugs and medical devices (Ting Zi [2017] No 42), in order to do a good job in the online procurement of new drug varieties in our district, we hereby notify the following matters related to the direct online procurement of new drug varieties: 1 Scope of procurement The target of new drug varieties directly online purchase is the new drug varieties that have obtained the drug approval documents according to the first and second categories of new chemical registration classification in the announcement on the issuance of the work plan for the reform of chemical registration classification (2016 No 51) 2、 Submit relevant materials and submit relevant qualification certificates and "two vote system" letter of commitment as required (see Appendix 1 and 2 for details) 3、 Delivery time and place: the enterprise can submit relevant materials to the front desk on the second floor of Taoyuan office area of Guangxi Public Resources Trading Center at any time on working days, and our department will hang the network in batches according to the work arrangement 4、 Note (1) if the network has been connected in Guangxi, the enterprise does not need to declare again (2) The relevant materials shall be submitted by the authorized person with the original ID card If the authorized person needs to be changed, it shall be handled in accordance with the relevant requirements of the "guide to handling affairs" on the homepage of the centralized procurement website of Guangxi Zhuang Autonomous Region (3) Enterprises with the following behaviors will be considered as unqualified 1 Those who violate laws and regulations in the centralized purchase of drugs and are punished by the food and Drug Administration of Guangxi Zhuang Autonomous Region and within the punishment period 2 Since 2015, according to the law enforcement and discipline enforcement authorities, the enterprise has involved in commercial bribery cases 3 The manufacturer's business license, drug business license or drug production license, GMP or GSP certification certificate are temporarily suspended or revoked by the competent authority 4 Failing to submit the annual report to the industrial and commercial organ through the credit information publicity system of the market subject and publicize it to the society 5 Enterprises with records of producing fake drugs since 2015 will not accept their application The record of producing fake drugs shall be based on the "administrative penalty decision" issued by the food and Drug Administration (the "administrative penalty decision" shall be affixed with the official seal of the provincial food and drug administration when it is used as the evidence) Appendix: 1 Qualification certification document submission instruction Rar 2 "Two vote system" commitment letter submission instruction Rar Guangxi public resources trading center centralized purchasing department of drugs and medical devices February 2, 2019
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