Vaccine Administration Law of the People's Republic of China (Закон Китайской Народной Республики «О вакцинации»)
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Vaccine Administration Law of the People's Republic of China
(Закон Китайской Народной Республики «О вакцинации»)
(Adopted at the 11th Meeting of the Standing Committee of the Thirteenth National People's Congress on June 29, 2019)
Chapter II Vaccine Development and Registration
Chapter III Vaccine Manufacture and Lot Release
Chapter IV Vaccine Distribution
Chapter VI Adverse Reactions Monitoring and Handling
Chapter VII Vaccine Post-Marketing Management
Chapter VIII Safeguard Measures
Chapter IX Supervision and Management
Chapter XI Supplementary Provisions
Article 1 This Law is enacted to enhance the vaccine administration, to ensure the quality and supply of vaccines, to standardize the immunization, to promote the development of the vaccine industry, and to safeguard public health and safety.
Article 2 This Law shall govern activities involving vaccine development, manufacture, distribution, immunization and vaccine administration in the territory of the People's Republic of China. In cases of not being stipulated in this Law, those activities shall be governed by the Drug Administration Law of the People's Republic of China, the Law of the People's Republic of China on the Prevention and Control of Infectious Diseases and relevant laws and administrative regulations.
For the purpose of this Law, vaccines refer to the prophylactic biological products for human immunization to prevent the occurrence and prevent, if not to be prevented, the prevalence of diseases, including immunization program vaccines and non-immunization program vaccines.
Article 3 The State implements the most stringent regulatory system for vaccines and adheres to principles of safety first, risk management, whole process control, scientific supervision and social co-governance.
Article 4 The State maintains the strategic and public welfare nature of vaccine products.
The State supports fundamental research and application research of vaccines, promotes development and innovation of vaccines and incorporates the development, manufacture and stockpile of vaccines for the prevention and control of major diseases into the national strategy.
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