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The packaging of medicines includes three aspects: the packaging materials and containers of medicines, the labels and instructions of medicines, and the packaging of medicines.The packaging of medicines should be made in strict accordance with the quality and safety requirements to ensure the health and safety of the users of medicines. The use of pharmaceutical packaging materials should also be checked for quality, and access procedures should be set up for the packaging of imported medicinal materials.
Chapter VI Management of Pharmaceutical Packaging
Article 52 The packaging materials and containers that come into direct contact with drugs must meet the requirements for medicinal use and meet the standards for ensuring human health and safety, and shall be approved by the drug supervision and administration department when approving drugs.
Pharmaceutical production enterprises shall not use unapproved packaging materials and containers that come into direct contact with drugs.
For unqualified packaging materials and containers that come into direct contact with drugs, the drug supervision and administration department shall order them to stop using them.
Article 53 The packaging of medicines must be suitable for the requirements of the quality of medicines and facilitate storage, transportation and medical use.
Chinese herbal medicines must be packaged for shipment.On each piece of packaging, the product name, place of origin, date, and transfer unit must be indicated, and a mark of qualified quality must be attached.
Article 54 The packaging of medicines must be printed or affixed with labels and instructions in accordance with regulations.
The label or manual must indicate the common name, ingredients, specifications, production enterprise, approval number, product batch number, production date, expiration date, indications or functional indications, usage, dosage, contraindications, adverse reactions and precautions of the drug.
The labels of narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, topical drugs and over-the-counter drugs must be printed with prescribed signs.
We all know that when we usually buy medicines, we often understand the indications, usage, production period and validity period of the medicines based on the relevant information on the outer packaging of the medicines. There are also detailed instructions for use, contraindications and adverse reactions in the packaging of the medicines. Legally, these contents must be present in the packaging of the medicines to help the users take the medicines in a timely and accurate manner.