LEXICON
No.69 July 11, 2011

Application for partial changes
(承認事項)一部変更承認申請
Minor change notice
軽微変更届
Application for a substitute product
代替新規申請

In principle, new applications for approval are required for changes in the brand name, active ingredients or their content or dosage form, while applications for partial changes (一部変更承認申請) are accepted for changes in ingredients other than the active ingredients, their...

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