Chapter VI

Control over Drug Packaging

Article 44 Immediate packaging materials and containers used by drug manufacturers shall fulfill the requirements for medicinal use and the standards for ensuring human health and safety, and be subject to registration upon approval by the drug regulatory department under the State Council.

The drug regulatory department under the State Council shall be responsible for working out and issuing the measures for control over immediate packaging materials and containers, the product directories and the requirements and standards for medicinal use.

Article 45 Packaging materials and containers selected for production of prepared slices of a Chinese crude drug shall accommodate to drug properties. No prepared slices of a Chinese crude drug may be marketed whose package fails to conform to regulations. A label shall be printed on or attached to the package of prepared slices of a Chinese crude drug.

On the label of prepared slices of a Chinese crude drug shall be indicated the name of the drug, specifications, origin or production, manufacturer, product batch number and production date; if the said drug is controlled by approval number, the drug approval number shall also be indicated.

Article 46 The package, label and insert sheet of a drug shall be printed in accordance with the provisions in Article 54 of the Drug Administration Law and those formulated by the drug regulatory department under the State Council.

The trade name of a drug shall conform to the provisions of the drug regulatory department under the State Council.

Article 47 The immediate packaging materials and containers, used by medical institutions for dispensing pharmaceutical preparations, as well as the labels and insert sheets thereof, shall conform to the provisions in Chapter VI of the Drug Administration Law and the relevant provisions in the Regulations, and be subject to approval by the drug regulatory department of the people’s government of the province, autonomous region or municipality directly under the Central Government.