China Regulatory Compliance

General Overview

Standards in “Guidelines for Drug Traceability Information System Construction” and “Encoding Requirements for Drug Traceability” must be implemented from the date of publication (April, 2019). Per the guidance, all drugs will be in the traceability system in 1st January 2022.

Barcode Requirements

Proprietary Chinise eCode: 20-digit code (7-digit product ID + 9-digit SN + 4-digit check digits) in a linear barcode

 

  GS1 standards using a GTIN as product code with the relevant application identifiers in a 2D Data Matrix Code.

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