China E-Coding Information

AS OF 09/2014
LYNX-CAPA China E-Coding Information
 Introducing
From May 1, 2013, pharmaceuticals on the essential drug list published by China’s Ministry of Health require serialisation. All levels of packaging need to be printed with the China National Drug Code and a serial number. The
serial number is a 20 digits number that includes manufacturer code, serial number and check digits and is a GS1 barcode.
In order to obtain that number, manufacturers use the China Product Identification and Tracking System (PIATS) to register their drugs. For products too small for the barcode, a solution will be found in cooperation with the Provincial Food and
Drug Administration. For imports, a local manufacturer, wholesaler or other office needs to be chosen as a local agent to
deal with the CFDA on the importer’s behalf.
All manufacturers need to follow good manufacturing practice for quality control and electronic drug monitoring etc.
By 2015, an e-Pedigree including product information, batch, serialization data, transaction information needs to be made
for all products. (Source: China: CFDA Order of Ministry of Health No. 90)
 Highlights
Tool-free adjustment on folding box and case sizes
Serialisation and aggregation implemented
Supports GS1, IFA, CIP 13, ITS, Bollino IPZS, Royal Vignette Belge
Integration of all major printer systems and China E-Coding
 Code Requirements
Code Specification
Barcode type
Code 128C according to ISO/IEC 15417
Barcode density
> 8 mils
Barcode size
X > 0.17 mm per module, recommended X > 0.25mm
Maximum is not specified, 0.5 mm suggestion
Data type
Numerical only
Data length
20 digits
Barcode height
> 8 mm
Maximum not specified, 30 mm suggestion
Barcode Quality Grade ANSI Grade C or 2 according to ISO/IEC 15416
Data Structure
Allowed numbers
Assigned by
Mark digit
Product code (NDC)
Serial number
Check digit
Calculated, algorithm unknown
Stop trigger
Check digit
10 Code words
(11 Modules per code word)
110 modules
Quiet zone (left)
Quiet zone (right)
165 modules
Given minimum module width of > 0.17 mm x 165 = 28.05 mm minimal code length
 scanware Track & Trace Solutions
The systems of the product family
LYNX-CAPA are designed for the packaging process in regard to Track &
Trace requirements.
Single and multiple units are marked
or labeled and verified. The processing of serialised data is handled by the
scanware DataHandler.
 The scanware Benefits
▪ Modular built for a multitude of
installation options
▪ Real-time operating system QNX®
for security and speed
▪ Uniform graphical interface and
easy-to-follow menu structure
▪ Fully 21 CFR Part 11 compliant
▪ Hard- and software are expandable
and upgradable
▪ Wear-free, electronically controllable scanware W-LED illumination
▪ Easy to install on all common
packaging machinery
▪ Communication with machine via a
VDMA-XML protocol
▪ Simultaneous use of numerous
inspection parameters
▪ Variety of statistical tools
LYNX-SPECTRA Product Inspection
Code Inspection
Pore Inspection
Track & Trace Solutions
scanware electronic GmbH
Darmstädter Straße 9-11
D-64404 Bickenbach
Telephon +49 6257 9352-0 Fax -22
[email protected]
▪ Development of special tasks and
requirements on your request
▪ Availability of all parts guaranteed
for 10 years
▪ Service offering solutions and
support within 24 hours
Quality is visible.
International Distributors:
Algeria | Brazil | Canada | Denmark | France | Ireland
Italy | Jordan | Mexico | Morocco | Norway | Puerto Rico
South Korea | Spain | Sweden | Switzerland | Tunisia
United Kingdom | United States
© scanware electronic GmbH 2014
Start trigger
This brochure contains information on legislation concerning Track & Trace regulations in a number of countries. This information was correct at
the date of publication. However, it does not constitute a legal guideline and the information is subject to change. Although we have taken pains
to provide you with accurate information, scanware electronic GmbH disclaims all responsibility for errors and omissions in this information.
Calculation of China E-Code Length