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 Program for Deepening the Reform of "Delegation of Administration, Services" and Optimizing the Business Environment for the Division of Key Tasks (hereinafter referred to as the "Program") to deepen the reform of "Delegation of Administration, Services" and optimize business operations in the next stage. Environmental work is deployed.
The "Plan" clarifies 25 key tasks in five areas. Among them, the first seven key tasks talked about the determination to cancel the approval of unnecessary intervention in micro-economic activities, and the approval that can be transferred from pre-approval to in-process and post-event supervision. From the perspective of decentralization and management, speed up the clearance of approvals that do not involve the layout of major projects and do not touch the bottom line of safety, effectively change the situation of "batch management", and further reduce the barriers to entry.
Among the specific measures, the "Plan" pointed out that optimizing the approval of pharmacy establishments, implementing a notification and commitment system for the approval of retail companies that only deal in Category B over-the-counter drugs nationwide, promoting the abolition of approvals for the establishment of pharmaceutical retail companies, and urging local authorities to clean up and open pharmacies Set unreasonable conditions such as spacing limits, and simultaneously strengthen supervision during and after the event. (The State Drug Administration takes the lead, and the relevant departments of the State Council and various regions are responsible for the division of responsibilities)
From this measure, we can see three advantages: First, the approval system for companies that only operate Type B OTC will implement the notification and commitment system; second, the approval for the establishment of pharmacies will be completely cancelled; third, the setting of local pharmacies is unreasonable The conditions need to be cleaned up.
The approval for the establishment of pharmacies has been cancelled in many places
In fact, before the release of the "Plan", the approval for the establishment of pharmacies was already cancelled. At present, Liaoning, Zhejiang and other provinces have clearly canceled the approval for construction preparations.
According to Zhejiang Province’s "Announcement on Suspension of the Administrative Licensing Matters for the Establishment of Pharmaceutical Business Enterprises in the Province", starting from September 25, 2020, the province will suspend the implementation of "preparation for pharmaceutical business (wholesale) enterprises" and "pharmaceutical business (retail) enterprises" Three administrative licensing items including preparation for establishment of chain enterprises, "preparation for establishment of pharmaceutical business (retail) enterprises (chain stores, single pharmacies)".
After the suspension, applicants only need to apply for the approval of "pharmaceutical business (wholesale) enterprise acceptance" to apply for the establishment of a pharmaceutical wholesale enterprise; to apply for the establishment of a pharmaceutical retail chain headquarters, they only need to declare "pharmaceutical business (retail) enterprise (chain enterprise) acceptance" Licensing items: To apply for the opening of drug chain stores and single pharmacies, you only need to declare the permission items of "pharmaceutical business (retail) enterprises (chain stores, single pharmacies) acceptance".
On March 26 this year, the Liaoning Provincial Food and Drug Administration issued the "Announcement on the Cancellation of Approval Items for the Licensing and Establishment of Pharmaceutical Dealing Enterprises". In order to further optimize the business environment and streamline the approval process for the establishment of pharmaceutical business enterprises, it was decided to cancel according to the relevant spirit. Pharmaceutical business enterprises (pharmaceutical wholesale and retail enterprises) apply for the approval of preparations in the "Pharmaceutical Business License".
The news pointed out that those who meet the application requirements can directly apply for the issuance of the "Pharmaceutical Business License" for newly established drug business enterprises. At the same time, the drug regulatory authority will no longer accept applications for the establishment of newly established drug business enterprises, and no longer issue preparation decisions.
In addition, from the feedback of the account readers, the author learned that the approval for the construction of Shandong Province has also been cancelled. In this regard, some readers said, "Xida Puben, every time I have to do a lot of information, the preparation process is tedious and time-consuming, and the rent can not afford to hurt.
only sell Type B OTC, you can get the certificate on the spot
It should be noted that the "Plan" talks about the implementation of a notification and commitment system for the approval of retail companies that apply for the establishment of only Category B over-the-counter drugs.
At the end of November last year, the State Food and Drug Administration made it clear that starting from December 1, 2019, in 18 places including Shanghai, Guangdong, Shandong, Yunnan, Liaoning, Hubei, etc., matters related to business licensing in the drug regulatory field will be implemented in accordance with the notification commitments, Two ways of optimizing examination and approval services to promote reform.
Since then, Zhejiang Jinhua began to implement the "Notice of Jinhua City on Simplifying the Operation and Approval of Class B OTC Drugs", and the approval procedures for the operation of Class B OTC drugs have been further simplified. On the morning of December 13, the city successfully issued the first "Application + Commitment" for the first time. "Drug Business License".
 　　 It is reported that the original enterprise had to obtain the qualification for operating Category B non-prescription drugs, and it had to go through the approval procedures such as application preparation, material review, on-site acceptance, and system approval before issuing a certificate. The approval time for the entire process would take at least 20 days. Nowadays, Jinhua City has simplified the whole process directly into "application + commitment". For eligible enterprises, new certificates can be issued on the spot.
 　　Similarly, after Kunming, Yunnan adopted the "informed and promised system" for approval, it took only one hour for Yixintang to obtain the first "informed and promised system" pharmacy version of the "Drug Business License".