Communist Repuppets in China-Laws on Vaccine Administration
link to library of congress post: https://www.loc.gov/law/foreign-news/article/china-vaccine-law-passed/
People's Republic of China Vaccine Management Law
(Adopted at the eleventh meeting of the Standing Committee of the thirteenth National People's Congress on June 29, 2019)
Published: 2019-07-03 13:58 Source: China National People's Congress
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Table of Contents
Chapter I General Provisions
Chapter II vaccine development and registration
Chapter III vaccine production and batch issuance
Chapter IV Circulation of Vaccines
Chapter V Vaccination
Chapter 6 Abnormal Reaction Monitoring and Treatment
Chapter VII Post-marketing Management of Vaccines
Chapter VIII Safeguard Measures
Chapter IX Supervision and Administration
Chapter X Legal Liability
Chapter 11 Supplementary Provisions
Chapter I General Provisions
Article 1 In order to strengthen the management of vaccines, ensure the quality and supply of vaccines, regulate vaccination, promote the development of the vaccine industry, protect public health and maintain public health security, the enactment of this Law.
Article 2 In the territory of the People's Republic of China engaged in vaccine development, production, circulation and vaccination and its supervision and management activities, the Law shall apply. This Law does not provide for the application of the "People's Republic of China Drug Administration Law", "Prevention and Control of Infectious Diseases Law" and other laws and administrative regulations.
Vaccines referred to in this Law, refers to the prevention and control of the occurrence of disease, epidemic, for the human immunization of preventive biological products, including immunization planning vaccines and non-immunization planning vaccines.
Article 3 The State implements the strictest management system for vaccines, insisting on safety first, risk management, full control, scientific supervision, and social governance.
Article IV of the State adhere to the strategic and public welfare of vaccine products.
The State supports basic and applied research on vaccines, promotes vaccine development and innovation, and incorporates the development, production and stockpiling of vaccines for the prevention and control of major diseases into the national strategy.
The State formulates development plans and industrial policies for the vaccine industry, supports the development and structural optimization of the vaccine industry, encourages the scale and intensification of vaccine production, and continuously improves the production process and quality of vaccines.
Article 5 The holder of a vaccine marketing license shall strengthen the quality management of the entire life cycle of the vaccine and be responsible for the safety, efficacy and quality controllability of the vaccine.
Units and individuals engaged in vaccine development, production, circulation and vaccination activities shall comply with laws, regulations, rules, standards and norms to ensure that the whole process information is true, accurate, complete and traceable, responsible according to law, and accept social supervision.
Article 6 The State implements the immunization planning system.
Residents living in the territory of China, according to law, the right to immunization planning vaccines, the obligation to fulfill the immunization planning vaccines. The government provides free immunization planning vaccines to residents.
People's governments at or above the county level and their relevant departments shall ensure that children of the appropriate age to receive immunization planning vaccines. Guardians shall ensure that school-age children receive immunization planning vaccines on time in accordance with the law.
Article 7 Local people's governments above the county level shall incorporate vaccine safety work and vaccination work into their national economic and social development plans, strengthen the capacity building of vaccine supervision and management, and establish and improve the working mechanism of vaccine supervision and management.
Local people's governments above the county level are responsible for the supervision and management of vaccines in their administrative regions, unified leadership, organization and coordination of the supervision and management of vaccines in their administrative regions.
Article VIII of the State Council drug supervision and management departments are responsible for the national supervision and management of vaccines. The health department of the State Council is responsible for national supervision and management of vaccination. Other relevant departments of the State Council in their respective areas of responsibility for the supervision and management of vaccine-related work.
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