Understand the two major drug traceability code specification documents in one article

On June 21, 2021, the official website of the State Food and Drug Administration issued two information standards, the "Specifications for the Printing of Drug Traceability Codes" and the "Specifications for the Display of Consumer Inquiry Results of Drug Traceability Codes", which are now open to the public for comments.

1.

1) Printing >

The printing examples of "Pharmaceutical Traceability Code Printing Specification" can be divided into one-dimensional barcodes and two-dimensional barcodes, as shown in the figure below:

One-dimensional code form to identify the printing >

An example of the printing >

The printing of drug traceability code should include 4 parts:

(1) "Drug Traceability Code": The words "Drug Traceability Code" should be printed above the symbols read by the drug traceability code device, and the handwriting should be clear and easy to read

(2) The characters that can be read by the human eye of the drug traceability code: should be printed from left to right or from top to bottom, and the handwriting should be clear and easy to read

(3) Symbols read by the drug traceability code equipment:

(4) Reading method of traceability code for identifiable drugs:

Note: When the maximum surface area of ​​the drug package is less than 10cm2, only the words "drug traceability code" and the symbols that can be read by the drug traceability code device can be marked

2) Printing position

Example of printing position of drug traceability code on large packaging

(1) The drug traceability code should be printed on the obvious visible place of the drug packaging, and should not be printed with other barcodes such as commodity barcodes, custom logistics codes, etc.

(2) When printing drug traceability codes on large drug packages, print at least two copies of the same drug traceability code label and stick them horizontally on two mutually perpendicular planes of the outer package to facilitate the scanning operation when the product is stacked

(3) The place where the drug traceability code label is attached should be eye-catching, and it must not cover the key information of the drug description such as the trademark, drug name, approval number, production date, production batch number, and expiration date on the drug package, and must not communicate with the country on the drug package.

(4) The printing of drug traceability codes should try to avoid perforations, punching cuts, openings, staples, drawing strips, seams, folds, folds, overlaps, ripples, ridges, wrinkles, other graphics and rough textures.

The drug traceability code should be printed on the drug sales packaging at all levels (including transparent packaging such as strapping and plastic packaging, unless otherwise specified)

3) Printing quality

Second, the highlights of the "Specifications for the Display of Consumer Inquiry Results of Drug Traceability Codes"

The "Specifications for the Display of Consumer Query Results of Drug Traceability Codes" is applicable to regulate the display of query results for consumers to query drug traceability codes on drug packaging through the drug traceability system, and stipulates the display of drug traceability information query results that consumers can query through drug traceability codes Request

Display example of consumer query result of domestic drug traceability code

Display example of consumer query results of imported drug traceability codes

(1) Domestic drugs: Including the name of the information providing platform and 30 drug-related information

1) Drug traceability code: ××××

2) Drug status: ××××

3) National drug identification code: ××××

4) Generic name of the drug: ××××

5) Drug standard code: ××××

6) Dosage form: ××××

7) Preparation specifications: ××××

8) Packing specification: ××××

9) Packaging conversion ratio: ××××

10) Validity period of the drug: ××××

11) Unit of drug validity period: ××××

12) Drug approval number: ××××

13) Validity period of drug approval number: ××××

14) Classification of drug registration: ××××

15) National Essential Medicine Labeling: ××××

16) Special drug management classification: ××××

17) Prescription drug identification: ××××

18) Name of the holder of the domestic drug marketing authorization: ××××

19) Uniform Social Credit Code (Domestic drug marketing license holder): ××××

20) The name of the domestic pharmaceutical manufacturer: ××××

21) Unified social credit code (domestic drug manufacturing enterprises): ××××

22) Name of sub-packaging factory: ××××

23) Unified social credit code (sub-packaging factory): ××××

24) Drug production date: ××××-××-××

25) The expiry date of the drug: ××××

26) Drug production batch number: ××××

27) Name of drug user unit: ××××

28) Health institution code: ××××

29) Unified social credit code of the drug user unit: ××××

30) Retail pharmacy name: ××××

(2) Imported drugs: Including the name of the information providing platform and 41 drug-related information

1) Drug traceability code: ××××

2) Drug status: ××××

3) National drug identification code: ××××

4) Generic name of the drug: ××××

5) English name of the drug; ××××

6) Chinese translation of imported drugs: ××××

7) Drug standard code: ××××

8) Dosage form: ××××

9) Preparation specifications: ××××

10) Packing specification: ××××

11) Packaging conversion ratio: ××××

12) Validity period of the drug: ××××

13) Unit of drug validity period: ××××

14) Drug approval number: ××××

15) Validity period of drug approval number: ××××

16) Imported drug registration certificate number: ××××

17) Validity Period of Imported Drug Registration Certificate: ××××

18) Imported drug batch number: ××××

19) Validity period of import drug approval documents: ××××

20) Classification of drug registration: ××××

21) National Essential Drug Label: ××××

22) Special drug management classification: ××××

23) Prescription drug identification: ××××

24) Name of the holder of the overseas drug marketing license (English): ××××

25) Overseas drug marketing authorization holder code: ××××

26) The name of the domestic pharmaceutical manufacturer: ××××

27) Unified social credit code (domestic drug manufacturing enterprises): ××××

28) Name of overseas drug manufacturer (English): ××××

29) Code of overseas drug manufacturer: ××××

30) Name of sub-packaging factory: ××××

31) Unified social credit code (sub-packaging factory): ××××

32) Name of imported drug agency: ××××

33) Unified social credit code (imported drug agency): ××××

34) Drug production date: ××××-××-××

35) The expiration date of the drug expiration date: ××××

36) Drug production batch number: ××××

37) Name of drug user unit: ××××

38) Code of health institution: ××××

39) Unified social credit code of the drug user unit: ××××

40) Retail pharmacy name: ××××

41) Unified social credit code (retail drugstore): ××××

(3) Consumers should directly display the drug traceability results after inquiring through the drug traceability code, and may not obtain the query results by setting irrelevant operations (such as clicking on advertisements)

(4) The consumer's query result of the drug traceability code should be prominently notified to the information provider of the query result

references

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