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On May 12, the State Food and Drug Administration issued an announcement, deciding to uniformly revise the [Adverse Reactions], [Contraindications] and [Precautions] items in the instructions of the anti-inflammatory analgesic ointment.
The marketing authorization holders of the above-mentioned drugs should report to the provincial drug regulatory authority for record before August 9, 2021, in accordance with the "Administrative Measures for Drug Registration" and other relevant regulations, in accordance with the requirements for revision of the instructions (see attachment).
If the revised content involves the label of a drug, it shall be revised together; the instructions and other content of the label shall be consistent with the original approved content.
The provincial drug supervision and administration department shall promptly urge the drug marketing license holders of the above-mentioned drugs in the administrative area to do the corresponding instructions revision and label and instruction replacement work as required, and severely investigate and punish violations of laws and regulations in accordance with the law.
Attachment: Revision requirements for the instructions of anti-inflammatory analgesic ointment
