According to the Drug Administration Law and other relevant laws and regulations, medical units in the application for preparation license, need to submit application materials to the State Drug Administration. Specific application materials include: the production unit's business license, drug production license, the acceptance report of the production plant and equipment, product quality standards, production process and other relevant information. After submitting the application materials, the State Drug Administration will review the application materials and conduct on-site inspections to determine whether the medical unit complies with the relevant regulations and standards. If the audit passes, the State Drug Administration will issue a preparation license before the medical unit can start producing and selling the relevant drugs. In addition, when applying for a preparation license, medical units also need to pay attention to the following points: 1. submit true and effective application materials, in line with the relevant regulations and standards. 2. actively cooperate with the State Drug Administration's audit and inspection during the application process. 3. after obtaining the preparation license, strictly in accordance with the regulations and standards of production and sales of the relevant medicines, to ensure that the quality and safety of drugs.
What are the details that need to be paid attention to when applying for a preparation license? When applying for preparation license, medical units need to pay attention to the following points: 1. Submit true and effective application materials to ensure the completeness and accuracy of the information. 2. Provide the conditions for on-site inspection in accordance with the requirements of the State Drug Administration, and actively cooperate with the inspectors to conduct audits and inspections. 3. Strictly follow the requirements of the preparation license to produce and sell the relevant products, to ensure that the quality and safety of medicines. 4. . regularly update the application materials and preparation license to ensure compliance with relevant regulations and standards.
Medical units need to submit application materials to the State Drug Administration when applying for preparation license. In the application process, medical units need to pay attention to the relevant regulations and standards to ensure that the application materials are true and effective, and actively cooperate with the State Drug Administration's audit and inspection. At the same time, after obtaining the preparation license, medical units need to strictly follow the relevant regulations and standards for the production and sale of relevant drugs to ensure the quality and safety of drugs.
Legal basis:
Supreme People's Court, "on the evidence of civil litigation," Article 27 of the People's Court commissioned the appraisal of the appraisal department to apply for reappraisal of objections to the appraisal conclusions, to provide evidence to prove the existence of one of the following circumstances, the People's Court shall be permitted to:
(a) appraisal institutions or appraisers do not have the relevant appraisal Qualifications;
(b) identification procedures are seriously illegal;
(c) identification of the obvious basis for the conclusion is insufficient;
(d) after the cross-examination of other circumstances that can not be used as evidence.