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Do I need to submit a supplementary application after the information in the package approval certificate has changed?
Medical Devices
Jul. 25th, 2023
If the approved information of pharmaceutical packaging materials and pharmaceutical excipients has changed, the supplementary application shall not be reviewed and approved separately, and the supplementary application for approval shall not be issued. Pharmaceutical packaging materials, pharmaceutical excipients manufacturers should take the initiati

If the approved information of pharmaceutical packaging materials and pharmaceutical excipients has changed, the supplementary application shall not be reviewed and approved separately, and the supplementary application shall not be issued. Pharmaceutical packaging materials, pharmaceutical excipients manufacturers should take the initiative to carry out the corresponding research work, timely inform the relevant drug manufacturers. The drug manufacturer shall conduct research on the alteration of the drugs involved to ensure the quality of the drugs. The Drug Administration is organizing the formulation of relevant regulations on the change management of pharmaceutical packaging materials and pharmaceutical excipients.

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