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Batch Numbers Shall be Correctly Declared for Imported Medicinal Products

To strengthen the source tracing and flow tracking of imported medicinal products, including drug substance, the Taiwan Food and Drug Administration(TFDA) requires importers to declare "batch number" on "Specification" column of import declarations. Keelung Customs urges all importers and customs brokers to comply with the above-mentioned regulation and make sure all information provided is correct.

Keelung Customs further explains that, in recent years, the TFDA has been actively promoting the policies of drug management and establishing the “Trace and Track System” to assure the quality, safety, and efficacy of drug substance or products, in case some fake drug events occur. Hence, in addition to carrying out the customs clearance procedures in accordance with the import regulations coded as “501”, “503” or “506”, importers of medicinal products shall correctly fill out batch numbers on the “Specification” column of their import declarations.

Keelung Customs also reminds that at present  "batch numbesr "are neither required to be declared nor to be checked during cargo examination by Customs. If importers apply with Customs for amendments to batch numbers after cargo release, while the validity of the batch numbers can not be verified, the application will be rejected or not as the case may be. Therefore, importers and customs brokers are called on to confirm the correctness of information on customs declarations before making entry.


Drug Product, Drug Substance, Batch Number, Amendment Made after Release

  • Publish Date:2019-01-18
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