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What laws are involved in the transfer of drug approval numbers?

The law involved in the transfer of drug approval numbers is the "Drug Administration Law of the People's Republic of China". The state does not allow the sale and transfer of drug approval numbers.

1. With reference to the provisions of Article 81 of the "Drug Administration Law of the People's Republic of China", whoever forges, alters, buys and sells, rents or lends licenses or drug approval documents shall be confiscated in violation of the law. If there is no illegal income, a fine of not less than 20,000 yuan but not more than 100,000 yuan shall be imposed; if the circumstances are serious, the "Drug Production License" of the seller, lessor and lender shall be revoked. Certificate", "Drug Business License", "Medical Institution Preparation License" or revoking drug approval documents; if a crime is constituted, criminal responsibility will be pursued in accordance with the law.

2. With reference to Article 31 of the "Drug Administration Law of the People's Republic of China", the production of new drugs or drugs with national standards must be approved by the drug regulatory department of the State Council and issued concurrently. Give drug approval numbers; however, this does not apply to the production of Chinese medicinal materials and Chinese herbal pieces that are not subject to approval number management. The catalog of Chinese herbal medicines and Chinese herbal pieces subject to approval number management shall be formulated by the drug regulatory department of the State Council in conjunction with the traditional Chinese medicine management department of the State Council. Drug manufacturers can only produce the drug after obtaining the drug approval number.

Extended information

1. Refer to Article 82 of the "Drug Administration Law of the People's Republic of China" and violate the provisions of this law by providing false certificates and documents. , samples or use other deceptive means to obtain the "Drug Production License", "Drug Business License", "Medical Institution Preparation License" or drug approval documents, the "Drug Production License" and "Drug Business License" will be revoked , "Medical Institution Preparation License" or revoking drug approval documents, their applications will not be accepted within five years, and a fine of not less than 10,000 yuan but not more than 30,000 yuan will be imposed.

2. With reference to Article 96 of the "Drug Administration Law of the People's Republic of China", the drug regulatory department shall perform supervision and inspection responsibilities in accordance with the law, and supervise the products that have obtained the "Drug Production License", Enterprises with a "Pharmaceutical Business License" engage in pharmaceutical production and business activities in accordance with the provisions of this Law.

If an enterprise that has obtained a "Drug Production License" or "Pharmaceutical Business License" produces and sells counterfeit or substandard drugs, in addition to pursuing the legal liability of the enterprise in accordance with the law, any dereliction of duty or dereliction of duty will be punished. The directly responsible person in charge and other directly responsible personnel of the drug regulatory department shall be given administrative sanctions in accordance with the law; if a crime is constituted, criminal liability shall be pursued in accordance with the law.

Official website of the National People’s Congress: Drug Administration Law of the People’s Republic of China