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Recently, the General Office of the State Council issued the "National Deepening of the "Management Service" Reform and Optimization of the Business Environment Teleconscing Key Tasks Division of Tasks Program (hereinafter referred to as the "Programme"), the next stage of deepening the "Management Services" reform to optimize the business environment work to deploy.
programme identified 25 priority tasks in five areas.
, the first seven key tasks address the determination to cancel the approval of unnecessary intervention in microeconomic activities and the approval that can be changed from pre-approval to post-event supervision.
from the point of view of the combination of discharge, speed up the clean-up does not involve major project layout and does not touch the safety bottom line of approval, and effectively change the "to approve" situation, further reduce the entry threshold.
Among the specific measures, the Program points out that optimizing the approval of the opening of pharmacies, implementing a system of notification commitment to the approval of retail enterprises applying to start a class B-only over-the-counter drug, promoting the cancellation of the approval of the preparation and construction of pharmaceutical retail enterprises, urging local governments to clean up unreasonable conditions such as spacing restrictions on the opening of pharmacies, and strengthening post-event supervision.
(led by the State Drug Administration, the relevant departments of the State Council and the regions responsible according to the division of responsibilities) from this measure we can see three major good: First, only the enterprise operating Class B OTC approval and implementation of the notification commitment system;
the establishment of a pharmacy for approval, there have been many cancellations in fact, before the release of the "Programme", the approval of the preparation of pharmacies has been in the scope of cancellation.
, Liaoning, Zhejiang and other provinces have explicitly cancelled the approval of preparation.
According to the Announcement of Zhejiang Province on the Suspension of the Construction of Administrative Permits for Pharmaceutical Enterprises in the Province, from September 25, 2020, the province suspended the implementation of three administrative licensing matters, such as "Drug Operations (Wholesale) Enterprises Construction", "Pharmaceutical Operations (Retail) Enterprises (Chain Enterprises) Construction" and "Pharmaceutical Operations (Retail Stores, Single Pharmacies) Construction".
After the suspension is suspended, the applicant shall only declare the licensing matters of "drug operation (wholesale) enterprise acceptance", apply for the establishment of the drug retail chain headquarters, only declare the licensing matters of "drug operation (retail) enterprise (chain enterprise) acceptance", and apply for the opening of a drug chain store and single pharmacy, and only declare the licensing matters of "drug operation (retail) enterprise (chain store, single pharmacy) acceptance".
On March 26 this year, the Liaoning Provincial Drug Administration issued the "Announcement on the cancellation of the approval of pharmaceutical business enterprises for the preparation and construction of construction matters", in order to further optimize the business environment, streamline the examination and approval process for the establishment of pharmaceutical business enterprises, in accordance with the spirit of the relevant, decided to cancel the pharmaceutical business enterprises (drug wholesale, retail enterprises) to apply for the "drug business license" in the preparation and approval.
the news pointed out that the newly opened pharmaceutical business enterprises, meet the application conditions can directly apply for the issue of "drug business license."
, the drug regulatory department will no longer accept applications for the establishment of new drug-operating enterprises, and will no longer issue decisions on preparation.
, from the account reader's feedback, the author learned that Shandong Province's preparation approval has also been cancelled.
, there are readers said, "Happy, every time to do a lot of information, the preparation process cumbersome and time-0, rent can not afford to hurt."
only sell Class B OTC, on-the-spot certification needs to be noted that the Program talks about the nationwide application for the establishment of only Class B over-the-counter drug retail enterprises to apply for approval of the implementation of the commitment system.
At the end of November last year, the State Drug Administration made it clear that, starting from December 1, 2019, in 18 places, including Shanghai, Guangdong, Shandong, Yunnan, Liaoning and Hubei, the relevant matters concerning the licensing of enterprises involved in the field of drug supervision will be promoted in accordance with the implementation of the commitment to inform and optimize the examination and approval services.
After, Jinhua, Zhejiang Province began to implement the "Jinhua City on the simplification of class B over-the-counter drug business approval work notice", Class B over-the-counter drug business approval process was further simplified, on the morning of December 13th the city successfully issued the first "application and commitment" "drug business license."
It is learned that the original enterprise to obtain Class B over-the-counter drug business qualifications, to apply for preparation, material audit, on-site acceptance, system approval and other approval procedures to issue certification, the entire process of approval time of at least 20 days.
, Jinhua City will be the whole process directly reduced to "application plus commitment", for eligible enterprises, the new certificate can be issued on the spot.
same time, Kunming, Yunnan province, adopted a "notification commitment system" approach to approval, one heart to get the first "notification commitment system" pharmacy version of the "drug business license" only took 1 hour.
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