The State Council issued a document to cancel the approval for the establishment of pharmacies

Recently, the General Office of the State Council issued the "National Deepening of the Reform of "Management Clothing" to Optimize the Division of Key Tasks of the Business Environment Teleconvo conference Call (hereinafter referred to as the "Programme"), which will deploy the next stage of deepening the reform of the "Management Service" to optimize the business environment.The Programme identifies 25 priority tasks in five areas. Among them, the first seven key tasks addressed the determination to cancel the approval of unnecessary intervention in microeconomic activities and to change 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 batch esotery" 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-up only for the operation of Class B over-the-counter drugs, promoting the cancellation of the approval of pharmaceutical retail enterprises for preparation and construction, urging local authorities 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 interests: First, only the enterprises operating class B OTC approval and implementation of the notification commitment system;

the preparation and approval of pharmacies, there have been many cancellationsIn fact, before the publication of the Programme, the approval of the establishment of pharmacies had already been cancelled. At present, Liaoning, Zhejiang and other provinces have explicitly cancelled the approval of preparation.According to zhejiang Province's "Announcement on the suspension of the implementation of administrative licensing matters for pharmaceutical enterprises in the province", from September 25, 2020, the province suspended the implementation of "drug business (wholesale) enterprises to build", "drug business (retail) enterprises (chain enterprises) to build" "drug business (retail) enterprises (chain stores, single pharmacies) to prepare for construction" and other three administrative licensing matters.After the suspension is implemented, the applicant shall only declare the licensing matters of "drug operation (wholesale) enterprise acceptance";

On March 26 this year, the Liaoning Provincial Drug Administration issued the "Announcement on the cancellation of the approval of drug business enterprises for the preparation and construction of the project" proposed, 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 source pointed out that a new pharmaceutical business enterprise that meets the application criteria may directly apply for the issue of a drug business license. At the same time, the drug regulatory department will no longer accept applications for the establishment of new drug-operating enterprises, and will no longer issue decisions on the preparation and construction.In addition, from the account reader's feedback, the author learned that Shandong Province's preparation approval has also been cancelled. In this regard, there are also readers said, "Happy, every time to do a lot of information, the preparation process cumbersome and time-complicated, rent can not afford to hurt."

only sell Class B OTC, on the spot can beIt is important to note that the Programme addresses the introduction of a nationwide notification commitment system for the approval of retail enterprises applying to start a Class B-only over-the-counter drug.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.Since then, 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 has been further simplified, on the morning of December 13, the city successfully issued the first "application and commitment" "drug business license."

it is understood that the original enterprise to obtain Class B non-prescription drug business qualifications, to apply for preparation, material audit, on-site acceptance, system approval and other approval procedures to issue certificates, the entire process of approval time of at least 20 days. Today, 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.Similarly, 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" took only 1 hour.
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pharmacy manager
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