Legal basis:
Article 30 of the Drug Administration Law of People's Republic of China (PRC) refers to the enterprise or drug development institution that has obtained the Drug Registration Certificate. The holder of drug marketing license shall be responsible for non-clinical research, clinical trials, production and marketing, post-marketing research, adverse reaction monitoring, reporting and handling of drugs in accordance with the provisions of this Law. Other units and individuals engaged in drug research, production, sale, storage, transportation and use shall bear corresponding responsibilities according to law. The legal representative and principal responsible person of the drug marketing license holder shall be fully responsible for the drug quality.
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