National Medical Products Administration: Sodium Aescinate Liniment Converted from Prescription to Over the Counter

2024-03-26

The National Medical Products Administration recently announced that according to the "Classification Management Measures for Prescription Drugs and Non prescription Drugs (Trial)" (formerly Order No. 10 of the National Medical Products Administration), after organizational verification and review, sodium saponin liniment has been converted from prescription drugs to over-the-counter drugs. The instruction manual of Sodium Aescinate Liniment shows that it is an over-the-counter analgesic drug. Used for acute closed soft tissue injuries, such as sprains, compression injuries, and bruising of tendons, ligaments, muscles, and joints. 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 December 20, 2024, 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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