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29 September 2016 EMA/382258/2015 Human Medicines Evaluation Divisions of nationally authorized medicinal productsActive substance: lorazepamProcedure no.: PS USA/00001909/20160130 Churchill Place
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The list of nationally authorised is a list of products or substances that have been approved by the national regulatory authorities for use or distribution within a specific country.
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Manufacturers, distributors, or importers of products or substances are typically required to file a list of nationally authorised.
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The purpose of the list of nationally authorised is to ensure that only approved products or substances are used or distributed within a specific country, in compliance with regulations.
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The information typically required on a list of nationally authorised includes details of the product or substance, its approval status, and any specific conditions for use or distribution.
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