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国家药监局发布疫苗生产流通管理规定 即日起施行

The regulations on the Administration of Vaccine production and Circulation issued by the State Drug Administration will come into effect on this day.

Jul 8, 2022 22:12
The State Drug Administration has promulgated the regulations on the Administration of Vaccine production and Circulation, which shall enter into force as of the date of promulgation. The regulations point out that the state implements a strict access system for vaccine production and strictly controls newly established vaccine production enterprises. The newly established vaccine production enterprises shall not only meet the conditions for the establishment of vaccine production enterprises, but also comply with the relevant policies of the competent departments of the national vaccine industry. The holder shall have the production capacity of the vaccine. When engaging in vaccine production activities, it shall, in accordance with the conditions stipulated in the Drug Administration Law, the Vaccine Administration Law and the measures for Supervision and Administration of Drug production, and in accordance with the prescribed procedures for the administration of drug production licenses, submit the application materials for drug production license to the drug supervision and administration department at the provincial level where the production site is located. If it is really necessary to entrust production in excess of the vaccine production capacity of the holder, the trustee shall be the pharmaceutical manufacturing enterprise that has obtained the scope of vaccine production. The packaging, labelling and sub-packaging of vaccines shall be carried out in pharmaceutical manufacturing enterprises that have obtained the scope of vaccine production.

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