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Agreeing to cancel the approval of the construction of pharmacies in Zhejiang Province Recently, the official website of the Chinese government issued the Approval of the State Council on Agreeing to Temporarily Adjust the Implementation of the Provisions of the Relevant Administrative Regulations in Zhejiang Province (hereinafter referred to as "Approval").
(Image information: both intercepted to the official website of the Chinese government) The approval states that, in order to further deepen the reform of "discharge" and optimize the business environment, it has agreed to temporarily adjust and implement the relevant provisions of four administrative regulations, including the Regulations on the Implementation of the Drug Administration Law of the People's Republic of China, in Zhejiang Province from now until December 31, 2023.
In accordance with Article 12 of the Regulations on the Implementation of the Drug Administration Law of the People's Republic of China, the applicant shall apply to the municipal drug regulatory authority in the district where the proposed enterprise is located or to the county-level drug regulatory authority directly established by the drug supervision and administration department of the people's government of a province, autonomous region or municipality directly under the Central Government.
the drug regulatory authority that accepts the application shall, within 30 working days from the date of receipt of the application, make a decision on whether to agree to the preparation in accordance with the provisions of the drug regulatory department under the State Council and in the light of the examination of the number, geographical, traffic conditions and actual needs of the local resident population.
the applicant completes the preparation and construction of the proposed enterprise, it shall apply to the original examination and approval authority for acceptance.
the original examination and approval authority shall, within 15 working days from the date of receipt of the application, organize the acceptance and acceptance in accordance with the conditions for start-up stipulated in Article 15 of the Drug Administration Law;
the approval instructions, the State Council agreed to the temporary adjustment and implementation of relevant content in Zhejiang Province, and to cancel the approval of the establishment of wholesale and pharmaceutical retail enterprises in Zhejiang Province.
adjustment, Zhejiang Province should strengthen after-the-fact supervision by strengthening the acceptance of drug wholesale and drug retail enterprises and carrying out inspection of drug management enterprises' compliance with the quality management norms of drug operations.
the cancellation of the whole country is sooner or later of course, the approval of the establishment of pharmacies cancelled, Zhejiang Province is not the first case, is not an exception.
As early as March 26 this year, the Liaoning Provincial Drug Administration issued the "announcement on the cancellation of the drug business enterprise license preparation and approval matters" put forward, in order to further optimize the business environment, streamline the approval process for the establishment of pharmaceutical business enterprises, in accordance with the spirit of the decision to cancel the pharmaceutical business enterprises (drug wholesale, retail enterprises) to apply for the "drug business license" in the preparation and approval.
liaoning Province, the news is clear, the new drug 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.
in order to fully implement the new version of the Drug Administration Law, last year, the State Drug Administration drafted and formed the Measures for the Supervision and Administration of Drug Operations (Draft for Comments) (hereinafter referred to as the Measures (Draft for Comments).
it is worth noting that in the implementation of the "discharge service", the Measures (Draft for Comments) simplify the procedures for the start-up of pharmaceutical business enterprises, the elimination of preparation and approval, management quality management certification and other provisions.
April 3, this year, the State Drug Administration on the "Drug Administration Law" related requirements, once again on the drug business supervision and management work has been standardized.
In accordance with the Notice of the State Drug Administration on Matters Related to the Supervision and Administration of Current Drug Operations, if a newly established pharmaceutical business enterprise applys for a license to issue a drug business license, the Drug Administration and Administration Department may combine the preparation and acceptance procedures and conduct the inspection of the bidding enterprise organization in accordance with the relevant requirements such as the Code of Quality Management of Drug Operations and the guidelines for on-site inspection.
the drug business license if it meets the requirements.
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