Electronic Regulatory Code

2022-09-14 14:38

The electronic supervision code is a mark given to each product by the Chinese government for electronic supervision of products. The electronic supervision code of each product is unique, that is, "one code for one item", just like the ID card of the product, referred to as the supervision code.
[Targeted] The drug electronic supervision code management system is aimed at supervising the state of drugs in the production and circulation process, realizing the product traceability and management of supervision departments and production enterprises, and safeguarding the legitimate rights and interests of drug manufacturers and consumers.
[Purpose] Relying on the national drug administration network platform covering the whole country to complete product status inquiry, traceability and management
(1) The whole process from production, distribution, transportation, storage to distribution to medical institutions is under the supervision of the drug regulatory department.
(2) Inquire about the production, operation, inventory and flow of each box, box, and batch of key drugs in real time. If there is a problem, you can quickly trace and recall the enterprise to accurately register it.
(3) Information warning
(4) Terminal mobile law enforcement. Drug supervision and inspection personnel can conduct timely inspections on the spot conveniently through mobile law enforcement systems, such as through the Internet, or through mobile phones.
[Scope of application] Some drugs have been implemented since April 2010
policy introduction
On December 4, 2007, the General Administration of Quality Supervision, Inspection and Quarantine issued a notice in the "Notice on Implementing the "Special Provisions of the State Council on Strengthening the Safety Supervision and Administration of Food and Other Products" and Implementing Electronic Supervision of Product Quality" (AQSIQ [2007] No. 582) , decided to implement electronic supervision of key products included in the management of industrial product production licenses and compulsory product certification (CCC). 69 key products in 9 categories, including cosmetics, will be fully electronically supervised by the end of June 2008, and all products can only be listed with an electronic supervision code.
At present, the electronic supervision code has been upgraded from 16 digits to 20 digits. After enterprises accurately register the commodity code of their products, the electronic supervision code can establish a corresponding relationship with the commodity code and complete the settlement and pricing function in the retail field.
The production enterprise transmits the source information such as the production and quality of the product to the supervision network database through the electronic supervision code, and the distribution enterprise conducts the purchase inspection and acceptance through the electronic supervision code and transmits the purchase information to the supervision network database, and transmits the sales information during the sale. In the supervision network database, these data information can be used for consumers to conduct authenticity and quality inquiries, for the government to conduct law enforcement crackdowns, quality traceability and product recall management, and for enterprises to understand market supply and demand, channel sales and fake information.
The 13-digit commodity barcode (currently mainly EAN-13/8) applied to retail commodities is a non-mandatory standard published by international organizations. Product circulation tracking cannot be achieved, and it is not applicable to complex prices such as jewelry and agricultural materials or products that are not sold in supermarkets.
The electronic supervision code is a product identification stipulated by the Chinese state. It is a code for one piece. It can realize the whole process supervision of product production, circulation and consumption, and realize the functions of product authenticity judgment, quality traceability, recall management and whole process tracking. Special products such as jewelry and agricultural materials are assigned codes.
Regulatory network
The supervision network assigns a unique electronic supervision code to each product, realizes "one code for one item" management, and collects the production, circulation, consumption and other dynamic information of the products corresponding to the electronic supervision code into the database in real time, through the seamless network covering the whole country. , Support millions of enterprises with thousands of trillions of products, super-large database and professional customer service center, establish electronic archives for the government to achieve quality supervision from the source, track and trace the market, request certificates and tickets, and implement incoming inspections Acceptance, establishment of electronic ledgers for purchases and sales, and recall of defective products provide information technology support. Finally, an electronic supervision chain for the whole process of industrial products from raw materials entering the factory, production and processing, factory sales to after-sales service was established, and an electronic supervision chain for the whole process of food from planting and breeding, production and processing, circulation and sales to catering consumption was established. The quality traceability and accountability system for quality and food safety provides an information technology platform and establishes a product quality electronic supervision network covering the whole society.
Policy Features
1) One piece one size.
Breaking through the traditional one-code-one-class mechanism, it can uniquely identify each product and track the whole process, and realize the unified function of government supervision, logistics application, merchant settlement, and consumer inquiry.
2) The database centrally stores dynamic information.
In order to break through the limitation that quality information and dynamic circulation information cannot be printed in advance, the supervision network centrally stores the dynamic information of products in a super large-scale supervision database in real time, and at the same time meets the needs of real-time dynamic information sharing and use of production, circulation, consumption and supervision.
3) National coverage.
Due to the characteristics of products being produced in one place and distributed and sold across the country, only a system network platform with unified and seamless coverage across the country can meet the requirements of the whole process of supervision.
4) Full tracking.
The supervision network collects the whole-process closed-loop information on the production source, circulation and consumption of products, and has the technical functions of information sharing and process linkage between relevant departments such as quality inspection, industry and commerce, commerce, drug administration, etc., in order to achieve product quality traceability and accountability. , problem recall and law enforcement anti-counterfeiting provided the necessary information support.
The role of the regulatory network
Through the supervision network, manufacturers and distributors can quickly understand product market conditions, protect intellectual property rights, realize brand promotion, and master logistics information; consumers can inquire about product authenticity and quality information by means of text messages, phone calls, networks, and terminal facilities; Supervision and law enforcement departments can timely grasp the information about product counterfeiting and illegal products and take enforcement actions quickly, carry out process traceability and accountability for quality problems, timely and accurate recall management of problem and defective products, and make government supervision, enterprise self-discipline and social supervision very important. A good combination has promoted the construction of a harmonious society.
The 13-digit commodity barcode (currently mainly EAN-13/8) applied to retail commodities is a non-mandatory standard published by international organizations. Product circulation tracking cannot be achieved, and it is not applicable to complex prices such as jewelry and agricultural materials or products that are not sold in supermarkets.
The electronic supervision code is a product identification stipulated by the Chinese state. It is a code for one piece. It can realize the whole process supervision of product production, circulation and consumption, and realize the functions of product authenticity judgment, quality traceability, recall management and whole process tracking. Special products such as jewelry and agricultural materials are assigned codes.
management requirements
The ultimate purpose of the use of electronic supervision codes is to manage the process and use of electronic supervision. The management method is realized through the data associated with the packaging supervision codes in the production process. The purpose of this management requirement is to standardize the operation process and ensure that the coding system can fully provide supervision codes. The requirements include: supervision code use management, barcode label design, personnel coding management, on-site operations, and circulation management requirements.
1. Supervision code usage management The electronic supervision code is uniformly issued by the electronic supervision and monitoring information network, and the number is limited. When the supervision code packaging or bar code is discarded, it can be reused through the system, so as to avoid excessive loss of supervision code and can not meet the subsequent production. need. If there is indeed a surplus of supervision codes, the discarded supervision codes do not need to be reused, but they need to be exported into prescribed files, and then logged in and uploaded to the monitoring information network system. After applying to obtain the supervision code, all coding must be realized by the coding system. In principle, no human intervention is allowed to ensure that the data of the coding system is consistent with the actual packaging situation.
2. Bar code label design
The regulatory code barcode adopts the CODE128C code system, the code length is 20 digits, the barcode density is greater than 7mil, the width is greater than 4cm, and the height is greater than 5mm. According to the management needs of the production enterprise, in addition to the supervision code, the barcode label can contain information such as product code, product name, production date, batch number, and expiration date.
3. Production line, workstation, personnel coding management
Production enterprises usually include multiple production lines, and the same production line may have multiple stations. In order to effectively manage on-site operations and strictly control the association of packaging data, it is necessary to code the production lines and stations, and collect data and information corresponding to each station. Feedback can be controlled and differentiated in sequence; different personnel in the operation process are assigned corresponding operation authority through personnel coding, so that each operator can perform their own duties according to the division of labor.
4. Job instruction barcode label
During the on-site packaging operation, there are normal packaging data collection and various abnormal processing. The operator needs to switch between different system functions. In order to facilitate the operation, the functional instructions are made into barcodes and pasted in a convenient location on the workstation (the specific location is at (determined during the project), when you need to perform a system function, you can scan and switch.
5. On-site operation requirements
The coding system converts the packaging supervision code data collected in the packaging process into associated data and then exports it into a specified format file for the monitoring of the circulation and use process. Therefore, the actual packaging must be consistent with the related data of the supervision code. If the actual packaging is inconsistent with the related data of the coding system due to human or other factors during the production process (for example, after the secondary packaging is completed, the first-level packaged The packaging is artificially replaced, but not systematically handled), there will be major problems in the process of circulation and use, and the coding system of this problem is difficult to detect and manage in the production process, and must be managed through management systems and administrative means. , performance appraisal and other auxiliary management to ensure the consistency of packaging and supervision codes.
6. Circulation management requirements
In the process of warehousing and circulation, the relevant management system needs to be able to support the management of supervision codes. For example, in warehouse management, when packaging changes are required, the changes in the associated data of the supervision codes need to be reflected, otherwise the original associated data has been Imported into the electronic supervision and monitoring information network system, the corresponding associated data will deviate from the actual packaging, which will bring trouble to the supervision of the circulation process.
Electronic supervision
Step 1: Regulatory Code Application Consulting Services
JWU can provide enterprises with free consultation on a series of processes such as application, registration, acquisition, code assignment, and activation of electronic supervision codes. Jiangwei has been engaged in the electronic supervision code assignment business for many years, and has accumulated rich experience in the supervision code assignment. We can choose the most suitable personalized solution for you in combination with the packaging appearance, production process, cost and many other factors of the company's products!
Step 2: Special code system for supervision code
Lianxin combines the experience of printing and assigning codes for supervision codes, and specially developed China's electronic supervision code system, which simplifies user operations and improves printing efficiency! Barcode type: UCC/EAN-128(Multi) Application identifier AI value is 21 Barcode structure: AI+20-digit supervision code Minimum barcode module width: ≥7mils (when the minimum module width is 7mils, the barcode width is 28mm)
Step 3: Electronic supervision code labeling, printing and coding
According to the regulations of the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, electronic supervision code labels must be printed and labeled according to certain specifications. Lianxin, combined with rich experience in coding, can provide enterprises with the best label selection scheme, that is, direct labeling, or Choose a printing solution that blends with your original logo!
Step 4: Supervision code quality traceability, anti-smuggling system
The supervision network assigns a unique electronic supervision code to each product, realizes "one code for one item" management, and collects the production, circulation, consumption and other dynamic information of the products corresponding to the electronic supervision code into the database in real time. For valuable products, raw material tracking, production and processing quality traceability, finished product maintenance, packaging and delivery tracking, and anti-smuggling management can be carried out through unique identification.
drug regulation
Drug electronic supervision collector, also known as drug electronic supervision handheld terminal.
On May 11, 2010, the State Food and Drug Administration (hereinafter referred to as the National Bureau) announced that the six major categories of drugs (mainly including high-risk drugs (narcotic drugs, first-class psychotropic drugs) and the four major categories of drugs (second-class psychotropic drugs) in the early stage On the basis of the successful implementation of the electronic supervision code, the State Food and Drug Administration Office [2010] No. 194 document was issued, which clearly required that all manufacturers producing drugs under the essential drug catalogue must register in 2011. Before March 31, 2019, the implementation of the electronic supervision code for the drugs under the essential drug list should be completed. At the same time, it is required that all distribution companies that wholesale and operate these essential drug catalogs must scan the storage and delivery of drugs with electronic supervision codes, so as to realize the full-process supervision of drug circulation.
Circulation enterprises that are included in the implementation of electronic supervision codes are mainly based on the work of in-warehouse scanning and out-of-warehouse scanning based on drugs with electronic supervision codes. Therefore, distribution enterprises only need to purchase handheld terminal (PDA) equipment that meets the corresponding interface documents of China's drug electronic supervision code to complete the implementation of electronic supervision code.
How do pharmaceutical wholesale enterprises choose handheld terminals?
First, look at the function and operation. After the drug supervision code data is collected by the dedicated handheld terminal for drug supervision, it needs to be uploaded to the China Drug Electronic Supervision Network in accordance with the requirements of the State Administration. According to the data upload form, the handheld terminal can be divided into three categories: the first type supports wireless upload, the collected data can be directly uploaded to the drug supervision platform through the handheld terminal, so that the verification and write-off can be completed in one step. It is the easiest to operate; the second type is that the handheld terminal wirelessly transmits the data to the PC, and then uploads the drug supervision code to the drug supervision platform through the PC. The operation is relatively simple, the workload is slightly larger, and it is beneficial for enterprises to import to the PC The third type is to import the supervision code collected by the handheld terminal into the PC through the data line, and upload it to the drug supervision platform through the client in the PC. The operation is relatively cumbersome and the workload is heavy, and the PC can be used. Backup or deepen the application of the drug supervision code.
Second, look at the configuration and price. A handheld terminal (PDA) is a high-tech product. Just like when we buy a mobile phone or a notebook, the selection of a handheld terminal also requires a comparison of product configurations, including processor, memory, operating system, communication method, reading accuracy, and whether it is a touch screen or not. All hardware parameters, etc., must be considered comprehensively. The prices of high, medium and low grade products generally range from 2,500 to 5,000 yuan. The price of products with convenient operation and high hardware configuration is higher. If you choose a low-end product, in view of the cumbersome operation of the product, you also need to consider the increased labor time cost. Enterprises choose products at the appropriate price according to their own financial budgets.
Third, look at scalability. For enterprises, in addition to completing the verification and write-off tasks of the State Bureau, the implementation of electronic supervision codes, and the supervision code adopts the technology of product digitization, and each drug (except special drugs) of the smallest sales unit has a similar ID card. The unique data of the number, the application of this technology will greatly enhance the application of enterprises in the field of product information management. If the existing collected electronic supervision code data can be effectively connected with other existing information systems (WMS, ERP, etc.) of the enterprise, the emergence of information islands can be avoided. The implementation of electronic surveillance codes can be transformed from a pure investment into a benefit. In addition, if enterprises consider developing their own software to run on the handheld terminal in the future, they also need to choose the operating system, external ports, and expansion ports of the handheld terminal.Fourth, look at after-sales service. Each drug administration PDA product includes drug administration software and hardware. Drug supervision software is developed by software companies authorized by the State Administration in accordance with the relevant policies and requirements of the State Administration, and the developed products can only complete the drug administration tasks of the State Administration after passing the interface test of the Drug Administration Network. Therefore, when purchasing equipment, drug supervision software is used as a part of the product and is checked by the national bureau, and enterprises can choose with confidence. And the software can even be installed on the machine by itself after purchasing lisence, which generally supports online updates. After the enterprise is familiar with the use of the product, there is less after-sales. The after-sales service of hardware is an important factor that we have to consider, because no matter how sturdy and durable hardware has been used for a long time, there will be different degrees of consumption or wear, or the operator's irregular use or accidental fall Broken, damaged, damaged, etc., all need to be resolved through after-sales. Therefore, it is particularly important to choose a supplier with hardware manufacturer maintenance qualifications, experienced maintenance experts, complete equipment, quick response, and comfort, flexibility and thoughtfulness. However, some developers who have obtained qualifications on the Drug Administration Online are only software companies. Hardware problems need to be returned to the original factory for maintenance, and the maintenance cycle is greatly prolonged, so the after-sales of hardware is another concern. Therefore, pharmaceutical companies should choose carefully when choosing PDA suppliers. Hardware requires after-sales more than software.


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