"Regulations on the Management of Chinese Medicine Drinking Packaging Labels (Draft for Soliciting Opinions)" released

Henan Market Supervision Week reporter Yang Lu

The packaging label of Chinese medicine drinks is closely related to the quality and safety of Chinese medicine drinks, which is one of the requirements for ensuring the production, circulation and use of drinks. In order to further regulate the management of packaging labels of traditional Chinese medicine, on July 8, the State Drug Administration issued the "Regulations on the Management of Packaging Tags of Chinese Medicine Package (Draft for Opinions)" (hereinafter referred to as the "Regulations").

Background: Tags of Chinese Medicine Drinking Pieces are chaotic

In order to regulate the management of pharmaceuticals and labels, in 2006, the original State Food and Drug Administration formulated and implemented the "Regulations on the Management of Drugs and Labels" (Original State Food and Drug Administration Order No. 24). Due to the particularity of Chinese medicine drinks, the provisions of this regulation clarify the management regulations of the packaging labels of Chinese medicine slices.

At present, there are various forms of packaging labels circulating in the market. Some varieties are difficult to distinguish the management attributes of products (medicinal materials and slices, food and drugs, etc.) only by packaging labels, resulting in difficulty in grass -roots regulatory law enforcement. With the inclusion of traditional Chinese medicine drinks into the national basic drug catalog and the national medical insurance and drug directory, regulatory agencies have paid more attention to the management of traditional Chinese medicine beverage packaging labels. Some provinces have begun to explore the management of Chinese medicine drinking slices packaging labels. "Packaging Management Requirements" provides a practical reference for further regulating the management of the packaging label of Chinese medicine.

Based on the actual supervision of traditional Chinese medicine drinks and the development of the development of the Chinese medicine decoction industry, in order to strengthen the standardized management of Chinese medicine drinks, the State Drug Administration drafted the "Regulations".

Regulations: Tags of Chinese medicine drinking tablets should be marked with the shelf life

According to the current "Drug Management Law" and "Regulations on the Implementation of the Drug Management Law", the content of the labeling of traditional Chinese medicine decoction slices should include product names, specifications, origin, production enterprises, product batch numbers, and production date. Indicate the approval number of the drug. Considering the needs of regulatory needs and ensuring the safe use of drinks, the "Regulations" increased the product attributes, installations, quality shelf life, and execution standards for the content of the label of Chinese medicine.

If the label in the Chinese medicine tablet cannot be marked with the above content because the packaging size cannot be marked, at least the product attributes, names, specifications, volume, production batch numbers and shelf life shall be marked. If the national drug standards or the provincial traditional Chinese medicine decoction specifications do not specify the specifications, the product specifications are not marked.

Production enterprises can mark the source of the medicinal materials of traditional Chinese medicine, the source of the Chinese medicine drinking slices, the production accessories, the storage, the address of the production enterprise, the production license number, the traceability code in the pharmaceutical information traceability system Wait. There is no information that has nothing to do with medicines.

Chinese medicine slices with special requirements for storage should be indicated at the eye -catching position of the label.

The "Regulations" also mentioned that Chinese medicine beverage films must be packaged during the transportation process. The label for packaging and storage packaging should be at least indicated that product attributes, names, specifications, storage, production date, product batch number, shelf life, production enterprise, can also indicate the number of packaging, transport precautions or other marks, etc. Necessary content.

Punishment: The content of the function of function and the excess of the specified scope shall be investigated and punished in accordance with the law

How to deal with Chinese medicine beverage packaging labels in compliance? The "Regulations" mentioned that if the packaging and labels of Chinese medicine are not in compliance with this regulation, the production and operation enterprises shall bear responsibility in accordance with the law. The drug supervision and management department shall be in accordance with the "People's Republic of China Drug Administration Law" and "Implementation Regulations of the People's Republic of China Drug Administration Law" and " Pharmaceuticals and label management regulations "and other relevant regulations were punished.

In addition, the content of the functional attendance indicated on the label of traditional Chinese medicine should comply with the standards of national drug standards or provincial traditional Chinese medicine decoction tablets. Those who exceed the scope of the regulations belong to Article 98 of the "Drug Administration Law of the People's Republic of China" in Article 98 of the "Indications or Functional Indications indicated by drugs" stipulated in Article 98 shall be investigated and punished in accordance with the law.

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