As China's pharmaceutical products management, separation of the social medical insurance system as well as medical, pharmaceutical and a series of policy formulation and implementation, at present, the distribution of pharmaceutical products from pharmaceutical companies to hospitals to consumers in the past such a one-way, closed circulation pattern, into the open market circulation loop. Information and automatically scan sales need to be standardized and normalized application of bar code. At the same time, pharmaceutical products directly related to consumer health, circulation of the whole process of tracking management of pharmaceutical products,More need to correct application of bar code.
Pharmaceutical products as a special commodity, by the manufacturer in the country of origin to its identity with the symbol indicates that the code correctly, not only can increase the efficiency of information flow throughout the supply chain, ensuring the consistency of information in the supply chain process, more important is you can avoid the intermediate links in circulation result from packaging, identifying again the error or health and safety issues. 70% pharmaceutical products have been manufacturing enterprises in China joined the bar code system and start using product bar codes on pharmaceutical products. To help companies correct use of the product the barcode, the preparation of this guide.
Second, pharmaceutical product overview of commodity bar code
Pharmaceutical product bar code is in the process of product and distribution of medicine national code (or encoding) and bar code symbol represents collectively, is the article numbering Center of China in accordance with the General rules of international (EAN · UCC system) implementation, and linked to the unity of standardized pharmaceutical product identification system, world wide. Including the medicine product codes and automatic identification of bar code symbols, part two.
2.1 medicine product codes
2.1.1 pharmaceutical composition of product code
Pharmaceutical product code code identified by the medicinal products and medicinal products an additional attribute code consists of two parts.
2.1.1.1 pharmaceutical product identification code
Pharmaceutical product identification codes, for a specific pharmaceutical products in circulation to remain stable throughout the life cycle of the project, standardization of "identity" encoding. Has a fixed structure, the world's only, digital, meaning no characteristics, is a pharmaceutical product keywords of the project flow the whole process of information exchange.
2.1.1.2 medicinal products attached property code
Pharmaceutical products additional attribute code is for presenting medical product circulation unit of additional property information related to the specific encoding, such as describing the specific medical product circulation unit production lot number, expiration date, size of the code.
2.1.2 pharmaceutical products identification code structure
Pharmaceutical product identification code structure aligned with the global trade item codes, EAN/UCC-14, UCC-12, EAN/UCC-13 and EAN/UCC-8 four, see below:
Description:
Indicator used only within EAN/UCC-14 identify the code structure. Interval for 1~9 assignment of indicator, quantitative trading projects which 1~8 used in pharmaceutical products, such as distribution of pharmaceutical products package; 9 for variable trade projects. The simplest method is assigned in sequence indicator figures, 1,2,3 ... Were assigned to the pharmaceutical product trading items in each combination.
Manufacturers identification code 7-9-numbers, by the article numbering Center of China unified registration, distribution, and management. Manufacturers identification code is the only code manufacturers in the world. Manufacturers identify the first three digits of the code (that is, N1 N2 N3) is the prefix code, is an international Article Numbering Association (EAN) code assigned to the Member organizations that represent countries or regions are responsible for assigning article numbering organization of manufacturers identification code. Current prefix code that represents the article numbering Center of China are 690, 691, 692, 693, 694, and 695.
Pharmaceutical product item code 5-3-numbers, registered by the article numbering Center of China's pharmaceutical enterprises discretionary management system members, project code distribution of pharmaceutical products see section 5.2 of these guidelines
Check code by 1-digit numbers, used to check other coding of true or false. It is based on the previous code values calculated according to certain mathematical methods. Please refer to the GB12904 or GB/T16986 of the bar of the EAN · UCC application identifier
EAN/UCC-8 identification code assigned by the article numbering Center of China unified registration. Have become members of the barcode system for Chinese goods enterprises to apply for the use of EAN/UCC-8 identification code.
UCC-12 identification code of the data structure is used in North America. To export pharmaceutical products to the Chinese manufacturers in North America, if you need to, you can apply to the article numbering Center of China UCC prefix.
China's pharmaceutical product identification code and EAN · UCC global trade item codes (GTIN) consistent structure. Called global trade item refers to information that can be defined in advance, and can be priced at any point in the supply chain, ordered or invoiced products or services. Global trade item codes is to provide the only global trade item identification codes. Visible, our pharmaceutical product identification code in line with globalization of medical product circulation among trading partners, and industry requirements for pharmaceutical products uniform logos standard.
2.1.3 selection of pharmaceutical product identification code
Pharmaceutical product identification code should generally chosen depending on the application environment (retail and non-retail), pharmaceutical product packaging type and other factors, determine the use one of the three structures, the basic principle see below.
In the database, pharmaceutical product identification codes are stored in the 14-digit structure, EAN/UCC-13, UCC-12, and EAN/UCC-8 identification code, can be preceded by a zero-padded to 14 bits, to meet the needs of storage formats. As shown in the following table.
Number structures 14-trade in pharmaceutical products project identification code
T1 T2 T3 T4 T5 T6 T7 T8 T9 T10 T11 T12 T13 T14
EAN/UCC-14 N1 N2 N3 N4 N5 N6 N7 N8 N9 N10 N11 N12 N13 N14
EAN/UCC-13 0 N1 N2 N3 N4 N5 N6 N7 N8 N9 N10 N11 N12 N13
EAN/UCC-8 0 0 0 0 0 0 N1 N2 N3 N4 N5 N6 N7 N8
2.1.4 medicinal products attached property code structure
Additional attribute code of pharmaceutical products in China, the use of application identifiers (AI) + additional property describes the coding structure of the code.
Application identifier is made up of 2~4 digit character, used to identify the meaning and format of the data. The meaning as described in the national standard GB/t 16,986 EAN application identifier · UCC application identifier. Typically, our pharmaceutical products attached property codes include batch number, date of production, date of packaging, shelf-life, duration and variable number of trade items, and so on. The composition and structure of the code
in the following table:
Application identifier (AI) data format notes
17 date of validity period
With six-digit
For the necessary elements
N1 N2 N3N4 N5 N6
30 total (package) volume
Only used for variable trade project
Length is variable, up to 8-bit
N1 ······ N8
10 lot number batch number
Variable length
Up to 20-bit
X1 ······ X20
11 validity of expression with the production date year month day
N1 N2 N3N4 N5 N6
13 validity of expression with the packaging date year month day
N1 N2 N3N4 N5 N6
Shelf life of 15 years, said the same validity period
N1 N2 N3N4 N5 N6
(Special Note: additional attribute code of pharmaceutical products must be used together with pharmaceutical product identification codes, applied separately makes no sense. ）
2.2 pharmaceutical product code bar code symbol
In accordance with common international rules, adopt a standardized bar code symbol indicates that the medicine product codes, for circulation in the pharmaceutical product code automatic identification and automatic data acquisition to provide technical support. Pharmaceutical product code symbol represents a EAN/UPC bar, IIF-14 bar and UCC/EAN-128 bar code three.
2.2.1 EAN/UPC Barcode
EAN/UPC bar code identification of the symbols used in the retail pharmaceutical products, including EAN-13,EAN-8, as shown in Figure 1 (a)-(b).
(a) (b)
2.2.2 EUR-barcode
ITF-14 barcode is used only in the non-retail channel sales, storage and transport of pharmaceutical products trade item identification. The bar code more suitable for direct printing on the corrugated cardboard or fibreboard. Symbolic representation as shown in Figure 2-a.
Packaging indicator
Figure 2-a
ITF-14 barcode symbol 14-digit code that corresponds to the number of structures. If you are identified with the ITF-14 bar code EAN/UCC-13 code, you need to add a zero before a 13-bit code, complete 14-bit. Here, 0 is not a packaging indicator. As shown in Figure 2-b.
Figure 2-b
2.2.3 UCC/EAN-128 barcode
UCC/EAN-128 the bar code symbol is a subset of Code128 code, EAN and UCC dedicated the genus. It is EAN · UCC bar code symbol used to represent the additional information in the system, are often used for non-retail trade item identification. 3-a the following figure is the validity period of a medical product, quantity and lot numbers UCC/EAN-128 bar code, Figure 3-b represents pharmaceutical product identification code UCC/EAN-128-only bar code.
Map 3-a map 3-b
Usually as follows select the bar code symbol of the pharmaceutical product identification code, specific application to participate in the relevant sections of the guidelines:
Identifies the code bar code symbol example
2.3 code of pharmaceutical products and medical products
Code as a process of pharmaceutical products and distribution of pharmaceutical products a unified coding system, is the process of pharmaceutical products and distribution of pharmaceutical products code.
Pharmaceutical products can be divided into two types of fixed and variable information information.
So-called fixed information, information that is associated with the trade in pharmaceutical products project. Same of medicine products trade project, description same of information, including determine the medicine products trade project of basic features information (as: medicine products of name, and dosage form, and specifications, and packaging specifications,) and related of management information (as: medicine products of manufacturer name, and price, and medicine products management classification,), due to its in determine of management system in the relative Yu specific medicine products project all unit of description fixed not changed, so said fixed information.
Different management systems, fixed information data sets are not the same, in particular management of information, in the different links in the circulation of medicinal products as a result of major management differ depending on the content, with no means of identification codes and the corresponding bar code symbol represents a link, access to information in the electronic directory is the best solution.
So-called variable information, refers to the trade of pharmaceutical products, vary with the specific units of different information, such as: medical validity period of the product, lot number, size, and so on. Variable information related only to specific pharmaceutical products unit, not the information systems of general data should be used in additional attribute code and UCC/EAN-128 bar code identification of pharmaceutical products, together with the cell flow.
Code of pharmaceutical products and pharmaceutical product information, see the following figure:
2.4 characteristics of pharmaceutical product bar code
Bar is the unity process of pharmaceutical products and distribution of pharmaceutical products pharmaceutical product code and bar code symbol represents collectively, with the following features
(1) scientific
Pharmaceutical product identification code a fixed-length, structure clear, hierarchical management, operability, and scientific.
(2) the global oneness
Pharmaceutical product bar code uniform item identification system in international (EAN · UCC system), its management into the global goods identification code system, with global consistency.
Pharmaceutical products as a special commodity, has been incorporated into EAN · UCC System. 2000 International EAN coding of medical products organization to its Member States according to a survey, in the 53 countries surveyed, including the United States, and Japan in 49 countries, and most of the European countries in the medical field using EAN · UCC System. Only the use of a uniform bar of pharmaceutical products, pharmaceutical products global trade flows can be realized, realization of pharmaceutical products from manufacturers, wholesalers, retail distribution, efficient supply chain management up to the consumer.
(3) encoding and uniqueness
Pharmaceutical product identification code using international EAN · UCC system two-part structure, segmented labeling (that is: prefix codes, manufacturer identification code and project code of pharmaceutical products by international article numbering, the article numbering Center of China as well as enterprise allocation management of pharmaceutical products), the uniform application. Ensure that medical coding and uniqueness of product identification codes on a global scale.
(4) information sharing
Commodity bar code system of pharmaceutical products to international identification codes as the core with no meaning, is the common language for all aspects of medical product circulation information exchange and keywords, with information sharing.
(5) can be automatically recognized
Pharmaceutical products product barcode with standardized, universal bar code symbol represents, enables pharmaceutical product code automatic identification. Through the application of bar code scanning technology, can significantly improve the speed of data collection and data processing. For medical product manufacturers, medical product circulation enterprises to achieve real-time data delivery, provided an effective tool for tracking of pharmaceutical products.
(6) the completeness
Pharmaceutical products the bar not only provides medical product circulation a unified identification code systems and bar code symbol represents, and also has a lifetime, the lot number and other properties of pharmaceutical products necessary for the circulation of information coding and bar code representation of the programme, with a complete.
C code and bar code symbols, retailing of pharmaceutical products
3 retail pharmaceutical product code and bar code symbol
Retailing of pharmaceutical products code relating to manufacturers, wholesalers, distributors, retailers and consumers, all sectors of the supply chain of pharmaceutical products, pharmaceutical products in the circulation of the most important and most basic encoding system. Retail pharmaceutical product code in this chapter for details.
3.1 code structure of retail pharmaceutical products
Typically, retailing of pharmaceutical products only identification codes and the corresponding bar code symbol indicates that you can meet the demands of retail scanning settlement. Have special requirements when the retail end, attached property code may be prepared.
3.1.1 structure of the retail pharmaceutical product identification code
Identification code of the retail pharmaceutical products only two structures can be EAN/UCC-13 or EAN/UCC-8.
3.1.1.1 EAN/UCC-13 code structure
EAN/UCC-13 is a 13-bit fixed-length digital structure of the code, by the manufacturer identification code, the item code and calibration code: three-part of pharmaceutical products, see below.
Manufacturers identification code EAN/UCC-13 data structure project of pharmaceutical products code check code
N1 N2 N3 N4 N5 N6 N7 N8 N9 N10 N11 N12 N13
Manufacturers identification code, the meaning of the medicine product codes, check code see above.
In our country, currently EAN/UCC-13 specific code structure has the following two types:
Type of construction project code prefix codes manufacturer code medicine product parity-check codes
Structure of a X13X12X11 X10X9X8X7 X6X5X4X3X2 X1
Structures II X13X12X11 X10X9X8X7X6 X5X4X3X2 X1
Note: Xi (I=1~13) says I digit code from right to left
When the prefix code is 690, 691, structure, prefix code: to 692, 693, 694, adopts the structure II.
3.1.1.1 EAN/UCC-8 code structure
EAN/UCC-8 is a 8-bit fixed-length digital structure of the code, its structure is as follows:
EAN EAN/UCC-8 data structures. UCC-8 prefix code pharmaceutical product code checksum
N1 N2 N3 N4 N5 N6 N7 N8
EAN/UCC-8 code assigned by the unified registration article numbering Center of China. Article numbering Center of China members are empowered, by virtue of system EAN Code use the principle applied to the article numbering Center of China using the code. The code prefix code, verification code and EAN/UCC-13 of the same meaning.
Only in the following circumstances, only members of the system to the article numbering Center of China submitted an application for using the EAN/UCC-8 code:
Ø EAN-13 more than printing barcode labels of maximum surface area 25% or all of the printable area, at 12.5%.
Ø printing labels the maximum surface area of less than 40 square centimeters or all of the printable area is less than 80 cm.
Ø medical product itself is less than 3 cm in diameter cylinder.
3.1.2 additional attribute code structure of retail pharmaceutical products
When the retail pharmaceutical products need the additional property information, should be expressed as the application identifier + additional attribute code, and simultaneously with the identification code identification. Usually additional property information including medical validity period of the product, lot number, etc. Specific code is structured as follows:
Application identifier (AI) data format notes
Pharmaceutical EAN product identification code. UCC-13 encoding
17 date of validity period
With six-digit
For the necessary elements
N1 N2 N3N4 N5 N6
10 lot number, lot number, variable length, maximum 20. For the necessary elements
X1 ······ X20
11 date of manufacture date with validity period
N1 N2 N3N4 N5 N6
Of which:
17 application identifier, indicating data representation is valid, if you do not need to indicate specific dates, the N5 N6 with "00".
Application identifier 10, indicates that the data represents production lot number.
11 application identifier, indicating data to represent the production date.
3.2 retail pharmaceutical product code bar code symbol
3.2.1 retail pharmaceutical product identification code symbologies
Retail pharmaceutical product identification code EAN/UPC bar code representation, identification code corresponding to EAN/UCC-13 and EAN/UCC-8, respectively EAN-13 and EAN-8 barcode, the sign structure see below. See GB 12904-2003 of the bar code.
Bar code symbol on the retail pharmaceutical products application examples are shown in the following figure:
3.2.2 additional retail pharmaceutical products property code symbology
When you need additional property information, express retail pharmaceutical products, by UCC/EAN-128 bar code attached properties and the code, and placed EAN/UPC under the bar code. See the following figure:
Description:
Note: additional attribute code must be used together with the identification code. As shown in the following figure.
Four, non-retail pharmaceutical product code and bar code symbol
4.1 non-retail pharmaceutical product code structure
Non-retail pharmaceutical product code code identified by the medicinal products and medicinal products an additional attribute code through the application identifier is connected to.
Non-retail pharmaceutical product identification code EAN/UCC-14 code structure. EAN/UCC-14 code is a fixed-length all-digital-type data structure, as shown below.
EAN/UCC-14 structure
Indicator
Inside retail pharmaceutical product identification code (not including the check digit)
Check digit
N1
N2N3N4N5N6N7N8N9N10N11N12N13
N14
Description:
Indicator assignment interval for 1~9. Among them, 1~8 for interior products determines the number and identity of the non-retail pharmaceutical product packaging stability and 9 per cent for variable number of packs the product of non-identification of retail pharmaceutical products.
When non-retail packaging of pharmaceutical products containing a single product, the identification code for the non-retail pharmaceutical products containing pharmaceutical products 14-digit code that identifies the code zero form. See the following table.
Data structure
Non-retail pharmaceutical product identification codes (14)
T1
T2
T3
T4
T5
T6
T7
T8
T9
T10
T11
T12
T13
T14
EAN/UCC-13
0
N1
N2
N3
N4
N5
N6
N7
N8