This standard specifies the terms and definitions, encoding principles, encoding objects, basic requirements, and code composition requirements for drug traceability codes. It also states the basic requirements for carriers, encoding insitutions, drug marketing authorization holders (MAHs) as well as manufacturers.

This standard applies to participants in drug treaceability activities, such as drug MAHs, manufacturers, suppliers, medicine-using institutions, and encoding institutions, to select or use drug traceability codes that comply with this standard for drugs sold and used in China.