Each province、Autonomous Region、The Food and Drug Administration of the Municipality directly under the Central Government，Xinjiang Production and Construction Corps Food and Drug Administration，All bureaus of the General Office、All units directly under the affiliated:

 

  According to the "People's Republic of China Food Safety Law", "Drug Administration Law of the People's Republic of China", "Regulations on the Supervision and Management of Medical Device", and "Regulations on the Regulations on Cosmetics Health Supervision" and the "State Council Office Office Opinions of System Construction "(National Office [2015] No. 95) File spirit，To control food and drug safety risk，Protecting consumer rights，Now put forward the following opinions on promoting stake betting appfood and drug production and My stake betting appoperators to improve the food and drug traceability system:

 

  1、Food and Drug Traceability System is an important part of the quality and safety management system of food drug production and operators。stake betting appfood and drug production and operators shall bear the main responsibility of the construction of the food and drug traceability system，Realize the source of its products that can be checked、Go chase。When quality and safety problems occur，Able to recall related products in time、Seeking the cause。

 

  2、Food production and operators shall purchase them in accordance with the requirements of relevant laws and regulations、Production process、Product inspection and sales destinations, etc.，Guarantee the authenticity of the data、Accurate、Complete and traceable。In principle，Food production and operators should use informationization methods to establish traceability system。Production and operators who do not have information conditions，Paper records can be traced backbone。Paper Record Storage period shall be implemented in accordance with the relevant provisions of the Food Safety Law of the People's Republic of China。

 

  3、Drug、Medical device manufacturers shall record various activities in accordance with the requirements of their production quality management specifications (GMP)。Records should be true、Accurate、Complete and traceable。Encouraged medicine、Medical Device Manufacturers are given a unique identifier for product minimum sales units，For the operator、Consumer recognition。Plant -implanted medical devices shall marked the name stake betting appstake online sports bettingor trademark of the production enterprise、Batch code (batch number) or series number，to ensure traceable。

 

  Drug、Medical device business enterprises shall record various activities in accordance with the requirements of their business quality management specifications (GSP)。Records should be true、Accurate、Complete and traceable，To ensure medicine、Medical Device Purchase Input、Maintenance、Out of the library、Transportation and other links can be traceable，and use the computer information management system to effectively manage in accordance with regulations。

 

  Drug、Medical Device User Units shall in accordance with the "Measures for Medical Supervision and Management of Medical Institutions (Trial)" and "Quality Supervision and Management Measures for Medical Devices" requiring the purchase of drugs and medical devices、Acceptance、Storage、Usage and other situations can be recorded。

 

  4、Cosmetics manufacturers shall be in accordance with the relevant regulations such as the "Regulations on the Supervision of Cosmetics"，Make sure product production、Quality Control and other activities can be traceable，and record the flow information of the product entering the circulation link，Implementing product goes to check、Question products recall in time。Cosmetics production and operators shall use imported cosmetics、Domestic special use cosmetics、Children's cosmetics and other high -risk products are the focus，Promoting the construction of traceability system。

 

  5、Local food and drug supervision departments at all levels shall be in accordance with the relevant laws and regulations such as the "Food Safety Law of the People's Republic of China", "Drug Management Law of the People's Republic of China", "Regulations on the Supervision and Administration of Medical Device", and "Cosmetics stake sports betting appstake sports betting appHealth Supervision Regulations"，Supervise the relevant production and operators in the administrative area to earnestly implement the responsibility of the product traceability，and record the source of the raw material、Production process record、The implementation of the construction requirements of the traceability system of purchase and sales records is urged and inspected and summarized。Timely investigation and punishment for those who do not perform the responsibility of traceability in accordance with the law。

 

  6、Encourage production and operators to use information technology to establish food and drug traceability system。Encourage information technology companies as third parties，Provide product traceability professional services for production operators。Food and drug supervision departments at all levels shall not force stake betting appfood and drug production and operators to accept the traceability service of designated professional information technology companies。

 

  Seven、Encourage Industry Association to organize enterprises to build a traceability information query platform，Provide data support for the regulatory authorities，Provide data sharing for production operators，Provide information query to the public。

 

  eight、Anesthesiologically、Psychiatric drug production and operation enterprises shall be in accordance with the requirements of the Monitoring Information Network in accordance with the Regulations on the Management of Anesthesia Drugs and Psychiatric Drugs，Establish a traceability system。Specific content shall be separately stipulated by the General Administration。

 

Food and Drug Administration

 

September 22, 2016