Announcement of the State Food and Drug Administration on Revising the Instructions for Haloperidol Preparations (No. 40 of 2021)

In order to further protect the safety of public medication, the State Drug Administration has decided to revise the instructions for haloperidol preparations
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1.
The marketing authorization holder of this product shall submit a supplementary application for the revision of the label in accordance with the "Administrative Measures for Drug Registration" and other relevant regulations and in accordance with the requirements for the revision of the label of haloperidol preparations (see attachment), before June 14, 2021 Report to the Drug Evaluation Center of the State Drug Administration or the provincial drug regulatory authority for the record
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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
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2.
The drug marketing license holder shall conduct in-depth research on the mechanism of new adverse reactions, take effective measures to conduct publicity and training on the use and safety issues, and immediately notify the drug business and use of changes in the content of drug safety.
The unit, instructs physicians and pharmacists to use drugs rationally
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3.
Clinicians and pharmacists should carefully read the revised content of the haloperidol preparation instructions, and when choosing medications, they should conduct a sufficient benefit/risk analysis based on the newly revised instructions
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4.
The patient should read the instructions carefully before taking the medicine, and strictly follow the doctor's advice
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5.
The provincial drug supervision and administration department shall supervise and urge the drug marketing license holders of this product in the administrative area to do the corresponding manual revision and label and manual replacement work as required, and severely investigate and punish violations of laws and regulations in accordance with the law
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Hereby announce
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Attachment: 1.

2.
Requirements for revision of the instructions for haloperidol injection

State Food and Drug Administration

March 15 2021

Annex to Announcement No.