Ministry of Health [MoH] is proposing amendment to Form 45 and Form 46 to make it mandatory that ‘each saleable unit of new drug should be accompanied by package insert for providing to the consumer’. Draft notification has been issued for comments.a458ee36-ee9c-4659-8b7a-c718b42fe197-original

Each saleable unit of the new drug shall accompany by the package insert

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