Conversion of bismuth potassium citrate capsules to over-the-counter drugs

2024-04-09

The National Medical Products Administration recently issued a notice that, in accordance with the "Classification Management Measures for Prescription Drugs and Non prescription Drugs (Trial)" (formerly Order No. 10 of the National Medical Products Administration), after being organized by the National Medical Products Administration for verification and review, bismuth potassium citrate capsules have been converted from prescription drugs to over-the-counter drugs. The instructions for bismuth potassium citrate capsules indicate that the product is a gastric mucosal protective drug, used for chronic gastritis and to alleviate stomach pain, heartburn, and acid reflux caused by excessive stomach acid. The announcement states that relevant drug marketing license holders are required to submit revised instructions to the provincial drug regulatory department for filing in accordance with relevant regulations such as the Drug Registration Management Measures before January 6, 2025, and promptly notify relevant medical institutions, drug trading enterprises, and other units of the revised content of the instructions. Other contents of the instructions for over-the-counter drugs beyond those specified in the template shall be executed in accordance with the original approval certificate. If the drug label involves relevant content, it should be revised together. Drugs produced by the holder of the drug marketing license from the date of filing shall not continue to use the original drug instructions. (Lai Xin She)

Edit:GuoGuo    Responsible editor:FangZhiYou

Source:people.cn

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