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On December 1st, Heilongjiang Provincial Drug Administration issued a Notice on The Optimization of the Opening and Approval of Pharmaceutical Business (Retail) Enterprises (hereinafter referred to as "Notice").
"Notice" said that according to the State Council, the provincial government on deepening the reform of "management services" to optimize the deployment of business environment, after research, the Bureau decided to further optimize the province-wide pharmaceutical business (retail) enterprises to open approval work.
The Notice clearly states that the approval for the opening of a drug operation (retail) license shall be optimized, the approval for the establishment and preparation of a drug retail chain store or a pharmaceutical retail enterprise shall be cancelled, and the approval and implementation of a commitment system shall be implemented for the approval and approval of drug retail chain stores and pharmaceutical retail enterprises that apply to operate only Class B over-the-counter drugs, and unreasonable conditions such as spacing restrictions shall not be set for the opening of pharmacies.
At the same time, the Notice also talks about improving the awareness of optimizing administrative licensing services, vigorously promoting "online approval", "no-meeting approval", "zero running" and "running at most one time", reducing the reporting materials, approval process and approval links according to the actual time limit for further compression of the approval period, reducing the approval, on-site inspection materials and other materials that can be queried through the information system within the approval authority;
, the whole country should be cleared in fact, Heilongjiang Province to cancel the pharmacy preparation approval, spacing restrictions, etc. , is also expected.
last month, the General Office of the State Council issued the "National Deepening of "Management Service" Reform and Optimization of the Business Environment Teleconvo conference call focus on the division of tasks program" to address this point.
The program points out that nationwide to apply for the establishment of only Class B over-the-counter drug retail enterprises to implement the notification commitment system, promote the cancellation of drug retail enterprises to prepare for approval, urge local clean-up of the opening of pharmacies set spacing restrictions and other unreasonable conditions, and with the strengthening of after-the-fact supervision.
From the point of view of this measure, mainly involves three major interests: First, only the enterprise operating Class B OTC approval to implement the notification commitment system;
announced that the cancellation of preparation approval in addition to Heilongjiang, Zhejiang, Liaoning and other places have been clear, cancel the approval of pharmacy 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.
original title: Drug regulatory documents, the removal of pharmacy spacing restrictions