On The Packaging Of Chinese Herbal Medicine Treatment Of Non
2003 12 18, the State Food Drugs Authority issued a “package on the strengthening of Chinese Herbal Medicine Regulatory Notice” (State Food and Drug Administration [2003] No. 358), called for July 1, 2004 after the Chinese Herbal Medicine is still not consistent with the behavior of packaging requirements to investigate and punish according to law . However, in the “Drug Administration Law,” “Drug Administration Law Implementing Regulations” and other related Laws and regulations China is no “visual” penalties, practice, law enforcement officers to deal with this problem inconvenienced. By combining experience, the following two points about this issue.
A correct understanding of “Chinese Herbal Medicine packaging” means. “Drug Administration Law” at 54 provides that Pharmaceutical Packaging Must follow the regulations printed on or affixed Label Accompanied by a prospectus. Label or must indicate the drugs General Name, ingredients, specifications, manufacturers, license number, production batch number, production date, valid, indications or functions, usage, usage, contraindications, side effects and precautions. “Drug Administration Law Implementing Regulations,” the 45th article, producing herbs and herbal medicines should be used and adapted to the nature of the packaging materials and containers; packaging does not meet the requirements of Chinese Herbal Medicine, not Sell . Chinese Herbal Medicine packaging must be printed or labeled. Chinese Herbal Medicine of the label must indicate the name, specification, origin, manufacturer, product batch number, production date, implementation of the approval number of Chinese Herbal Medicine must also indicate the drug approval number. The author believes that under the above provisions, Chinese Herbal Medicine packaging shall consist of two elements: First, drug packaging materials; second labeling, the labels on Chinese Herbal Medicine.
Second, Chinese Herbal Medicine packaging of non-compliance situation should be sub-case.
First, the labels do not meet regulations. 1. On the implementation of approval number of Chinese Herbal Medicine, such as gelatin, Dragon’s blood and so, if the labels are not marked approval number and should be regarded as a license number, law-enforcement officers may determine that a violation of the “Drug Administration Law” at 48, paragraphs (b) of this article, based on “Drug Administration Law” article by the 74th Fake Punished. 2. Failure to implement the approval number of the Chinese Herbal Medicine without a label or tag content does not indicate the production batch number, and may be of inferior quality punished. Is a violation of the “Drug Management Law” fourth 19, paragraphs (b) requirements, according to “Drug Control Act,” the 75th section shall be punished. 3. Labels are not labeled except license number, batch number other than the content, that is not labeled specifications, place of origin, manufacturer, production date, the violation of the “Drug Administration Law” at 54, “Drug Administration Law Bill “the 45th article, should be based on” Drug Administration Law, “the 86th article,” Drug Administration Law Implementing Regulations, “the 73rd article, the production company ordered to make corrections (asking them to complete marking labels), warning; circumstances are serious, on the implementation of approval number of Chinese Herbal Medicine impose revocation of the approval documents. On drugs Operate The use of units ordered to make corrections (required to immediately stop sales of its use, and pharmaceutical companies to return the original supplier), given a warning.
Second, the packaging materials do not meet regulations. The author believes that the production company on the Chinese Herbal Medicine can be found a violation of the “Drug Administration Law” at 54, “Drug Administration Law Implementing Regulations,” the 45th article, should be based on “Drug Administration Law,” the 86th Article “Drug Administration Law Implementing Regulations,” the 73rd section shall be punished. On medicines management, and use units, packaging materials should not meet the required Chinese Herbal Medicine for testing, to determine whether non-compliance due to packaging materials lead to drugs deterioration, mold, insects or pollution, Test Failed directly by fake, the penalty imposed, order the return of the original supply of qualified units, given a warning.
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