On February 19, The Ministry of Health, Labor and Welfare (MHLW) issued a notice requesting marketing authorization holders to make necessary preparations for the digitization of package inserts of prescription drugs, etc., to be started in August, such as writing codes on product containers, etc., that allow access to information on the web. It also requires that information linked to a product code and a package insert number be registered on the website of Pharmaceuticals and Medical Devices Agency (PMDA), etc.
The revised Pharmaceuticals, Medical Devices and Other Therapeutic Products Act (PMD Act) stipulates that the digitization of package inserts will begin on August 1 to inform medical institutions and pharmacies of the package’s latest information inserts and to avoid wasting paper.
The notice, positioning the content of the information contained in paper package inserts as “precautions and other information,” required the marketing authorization holders to make it available via the Internet.
Specifically, GS1 codes are to be written on the product containers, etc., for pharmaceuticals other than pharmaceuticals requiring guidance and OTC pharmaceuticals, medical devices other than specific items, and products for regenerative medical products. The container, etc. to be written on is the minimum packaging unit sold from wholesale distributors to medical institutions.
However, for pharmaceutical products with a small area of container, etc., the notice did not require the code be written on the container, etc. if a document with the code is included in the product package.
The information linked to the product code and the package insert number will be registered in the “Safety Information Posting System” on the PMDA website so that the latest information on the PMDA website can be accessed by reading the code with an application.
When the manufacture and sale of a product is terminated, the publication of information will be closed after considering the expiration date and the status of use in medical institutions.
When a product is purchased for the first time, paper package inserts should be, in principle, provided by MRs. When revisions are made, the method of provisions, such as sending a paper package insert or electronic data can be selected.
As a transitional measure, the notice allowed a paper package insert to be included in the package of products that will be manufactured and sold by the end of July 2023.
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