Interpretation of Two Standards of Drug Traceability Code Identification Specification


Time:

2022-06-30

Interpretation of Two Standards of Drug Traceability Code Identification Specification

Background and basis for the preparation of 1. standards
1. Why is it necessary to develop two standards: "Drug traceability code identification specification" and "Drug traceability consumer query result display specification"?
In the early stage, the State Food and Drug Administration issued 10 drug traceability standard specifications, including "Guidelines for the Construction of Drug Information Traceability System" and "Drug Traceability Code Coding Requirements", which have received extensive attention from the industry. In the standard implementation process, the industry has different understandings and practices on some implementation details such as the identification of drug traceability codes and the query and display of drug traceability information. In order to guide drug marketing license holders and manufacturers to carry out drug traceability related work from the perspective of technical implementation, under the guidance of the Drug Registration Department and the Drug Supervision Department of the State Food and Drug Administration, the Information Center of the State Food and Drug Administration organized the compilation of the "Drug Traceability Code Identification Standard" and "Drug Traceability Consumer Query Results Display Standard" two standards.
2. What is the basis for formulating the two standards of "Drug Traceability Code Identification Specification" and "Drug Traceability Consumer Query Results Display Specification?
The preparation of the standard is strictly based on the" the People's Republic of China Drug Administration Law "," Drug Production Supervision and Administration Measures "," Drug Registration Management Measures "," Drug Instructions and Labeling Management Regulations "," Guiding Opinions on the Construction of Drug Information Traceability System "(State Drug Administration No. [2018] 35) and other relevant laws and regulations, follow the national standards such as" General Requirements for Important Product Traceability System "and the drug traceability standards issued by our bureau.
Main Contents of 2. Standard
3. What are the main contents of "Drug Traceability Code Identification Specification? Apply to what situation?
" Drug Traceability Code Identification Specification "stipulates the principles, general requirements, style requirements, location requirements and quality requirements of drug traceability code identification, which is applicable to standardize and guide drug marketing license holders and manufacturers to mark drug traceability codes by printing and pasting on all levels of sales and packaging units of drugs sold and used in China.
4. What are the main contents of the "Drug Traceability Consumer Inquiry Results Display Specification? Apply to what situation?
" Drug traceability consumer query results display specification "stipulates the overall requirements, display method requirements and display content requirements of drug traceability information results queried in the drug traceability system through drug traceability codes, and is applicable to standardizing and guiding drug marketing license holders and manufacturers to provide drug traceability information query results to consumers through the drug traceability system.
3. Description of relevant contents
5. What is the identification of drug traceability code?
The identification of drug traceability code is the identification of drug traceability code and related information on drug packaging by printing, pasting and other methods, which is composed of numbers, letters, characters and bar codes.
6. What contents should be included in the identification of the drug traceability code?
The contents of the identification of the drug traceability code should include the words "drug traceability code", the characters recognized by the human eye of the drug traceability code and the symbols recognized by the drug traceability code equipment (generally including one-dimensional bar code or two-dimensional code).
7. What are the principles of drug traceability code identification?
The principles of drug traceability code identification include: First, easy identification. Drug traceability code identification should ensure that it can be easily and accurately read by users and related equipment. Second, clarity, drug traceability code identification should ensure that the image is clear, color and background color contrast. Third, the significance, drug traceability code should be marked in the obvious visible place, easy for users to quickly find and locate.
8. What are the general requirements for drug traceability code identification?
The general requirements for drug traceability code identification include: First, the drug traceability code identification should comply with the requirements of relevant national laws, regulations and standards. Second, the drug traceability code identification should be clear and readable, and can be read by scanning equipment and human eyes.
9. How to mark the drug traceability code in large drug packages?
In order to facilitate the scanning operation when large drug packages are stacked, when marking the drug traceability code in large drug packages, it should be marked on two or more planes. Enterprises can choose different planes to mark the drug traceability code according to the specific storage and transportation conditions.
10. What should be paid attention to when marking drug traceability codes on special packaging materials such as reflective materials and heat shrinkable films?
When marking drug traceability codes on special packaging materials, the influence of packaging materials on the recognition of drug traceability codes should be fully considered to ensure that the drug traceability codes can be read. If the drug traceability code is marked on the package made of reflective material, corresponding measures shall be taken to eliminate the influence of reflection on the recognition of drug traceability code (including human eye and equipment recognition); When marking the one-dimensional bar code on the heat shrinkable film, the influence of deformation on the recognition of one-dimensional bar code (including human eye and equipment recognition) shall be fully measured and overcome, and the strip direction of one-dimensional bar code shall be consistent with the direction with the direction with the maximum shrinkage rate of heat shrinkable film.
11. What are the general requirements for the results of drug traceability consumer inquiries?
The general requirements for the results of drug traceability consumer inquiries include: First, the results of drug traceability information inquired in the drug traceability system through the drug traceability code should comply with the requirements of relevant national laws, regulations and standards. Second, the drug traceability information found in the drug traceability system through the drug traceability code should be consistent with the actual situation of the drug.
12. What are the requirements for the display of drug traceability consumer query results?
In order to facilitate consumer inquiries and avoid misleading, the query results provided by the drug traceability system should directly display drug traceability information, including the words "drug traceability information", and the drug traceability information provider of the query results should be notified in a prominent position. It is recommended to use the words "this traceability information is provided by the traceability system authorized by ××× (marketing license holder).