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Japan PMDA: Guidelines for Labeling of Codes on Containers to Identify Prescription Drugs & Med. Dev

Recently Japan's the Ministry of Health, Welfare and Labour (MHLW) - Pharmaceuticals and Medical Devices Agency issued a Notification mentioning an update and implementation on “Labeling of Codes on Containers to Identify Prescription Drugs”.

The labeling of codes on containers, etc., is to identify prescription drugs. The implementation of this guidance will prevent accidents resulting from improper handling of pharmaceuticals in medical care, to ensure traceability, and promote the effective distribution of pharmaceuticals.


The labeling shall be applied to prescription drugs (excluding in vitro diagnostics), and the product code, expiration date manufacturing number or manufacturing code, and quantity shall be labeled according to the unit of packaging and the type of prescription drug.


The guidance details topics such as Exceptions to the labeling of identification codes on containers, etc, Product codes, Changing Global Trade Item Numbers (GTIN), Barcode symbol system, Order of notation of the data elements and GS1 application identifier, Applicable period etc.



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