It will be more convenient for 18 provinces to open drugstores in the future

Source: sepiland - pharmacy Manager ▍ editor: yuanashley Up to now, there have been 18 provinces (districts, cities) pilot drug regulatory field "license separation" reform, and it will be more convenient to open pharmacies in the future In the past, it took at least 60 days to get the certificate after submitting materials, waiting in line, special certification and other processes to apply for the drug trade license, but now it is less than one hour But that has changed in the near future At 2:00 p.m on December 5, Yixintang pharmaceutical clerk and Yin walked into Xishan District Government Affairs Service Center, and delivered the prepared materials to the medical equipment and drug business license processing window of the district market supervision bureau In less than an hour, he got a new drug license According to the implementation plan for the State Drug Administration to implement the full coverage pilot implementation plan for the reform of "separation of license and license" carried out by the State Council in the pilot free trade zone (hereinafter referred to as the "implementation plan") recently issued by the State Drug Administration, in the future, it will comprehensively clean up the business license matters related to the field of drug supervision, promote the reform of the approval system by classification, and further expand the scope of drugs, medical devices Cosmetics enterprises have the right to operate independently In short, it is to simplify various processes, improve the independent management rights of enterprises, and make it more convenient to run enterprises in the future Since December 1 this year, in Shanghai, Guangdong, Tianjin, Fujian, Liaoning, Zhejiang, Henan, Hubei, Chongqing, Sichuan, Shaanxi, Hainan, Shandong, Jiangsu, Guangxi, Hebei, Yunnan, Heilongjiang and other pilot free trade zones, the reform of business license related matters in the field of drug supervision has been carried out in accordance with the two ways of notification commitment and optimization of approval services There are 28 licensing issues in the field of drug supervision involved in the pilot project, including 3 licensing issues that implement the notification commitment, which are respectively the approval of drug Internet information service, the approval of medical device Internet information service, the permission of medical institutions to use radioactive drugs (class I and class II); 25 licensing issues that optimize the approval service, including the permission of drug manufacturers and radioactive drug manufacturers Approval, cosmetics production license, etc Take the latest policies of Hubei Province as an example In the future, whether it's certificate handling service or daily supervision, when chain stores and individual companies change certificates or cancel relevant certificates, should they go to the provincial drug administration or the municipal and county market supervision departments? According to the latest regulations on the functional allocation, internal organization and staffing of Hubei Drug Administration issued by the general office of the CPC Hubei Provincial Committee and the general office of the provincial government, the provincial drug administration is responsible for the licensing, inspection and punishment of the headquarters of drug retail chain enterprises; the municipal and county level market supervision departments are responsible for the licensing, inspection and punishment of retail pharmacies (including chain pharmacies), and in accordance with the provincial drug administration We will make arrangements and arrangements for drug administration licensing and daily supervision Accordingly, for newly established drug retail chain enterprises, the headquarters of the chain enterprises shall respectively apply for administrative license to the provincial drug administration and the municipal and County Market Supervision Bureau (the administrative examination and approval Bureau) Among them, the local municipal and County Market Supervision Bureau (the administrative examination and approval Bureau) shall first organize on-site inspection and license issuing according to the standards of local drug retail enterprises 。 After the headquarters of the chain enterprise submits the license of its subordinate stores to the provincial food and drug administration, the provincial food and drug administration shall organize on-the-spot inspection and certificate issuance with reference to the current standards of drug wholesale enterprises Spot check shall be carried out in no less than 3 subordinate stores The headquarters of drug retail chain enterprises shall apply to the provincial drug regulatory bureau for the handling of such licensing matters as renewal, change, reissue and cancellation of drug trading license, which shall be directly handled by the Provincial Bureau or jointly handled by the municipal and county market regulatory bureaus (administrative examination and approval bureaus) as required If a drug retail chain enterprise increases its subordinate stores, the chain headquarters shall apply to the municipal and County Market Supervision Bureau (administrative examination and approval Bureau) under its jurisdiction The local municipal and County Market Supervision Bureau (administrative examination and approval Bureau) shall carry out the acceptance according to the acceptance standards of the retail drugstore, and issue the drug business license if it meets the requirements The chain headquarters shall submit the license information to the provincial drug administration in time.