What is intermediate packaging?
In the medical and pharmaceutical fields, intermediate packaging plays an essential role. According to Clause 2, Article 2 of Circular 01/2018/TT-BYT, intermediate packaging is packaging used to package one or several drug units with direct packaging and located in the outer packaging of the drug.

So, what is the purpose of intermediate packaging? Its core function is to protect and maintain the quality of the drug. By enclosing the drug discreetly, this packaging prevents adverse effects from external factors such as light, humidity, temperature, thereby ensuring the safety, quality and effectiveness of the drug. Moreover, intermediate packaging is also a source of important information for users, including drug name, ingredients, instructions for use, dosage, date of manufacture and expiry date, supporting the proper and safe use of the drug.

In addition, intermediate packaging also contributes to the process of controlling and managing pharmaceuticals, allowing for the tracking and inspection of drug units during transportation and storage, ensuring product integrity and traceability. To meet the requirements for intermediate packaging, pharmaceutical manufacturers must strictly comply with the regulations and standards issued by health management agencies to ensure the quality, safety and accuracy of information on the packaging.

What minimum contents must the intermediate packaging label of a drug have?
The intermediate packaging label of a drug must have at least the contents specified in Clause 1, Article 8 of Circular 01/2018/TT-BYT on intermediate packaging labels of drugs as follows:

Drug name: The intermediate packaging label must clearly state the name of the drug. This information helps users to accurately identify and distinguish the drug product. The drug name must be clearly stated, not causing misunderstanding or confusion with other products.
Batch number: The intermediate packaging label must clearly state the batch number of the drug. The batch number is an important piece of information to track and check the origin, quality and expiry date of the drug. Through the batch number, we can identify the origin of the product and monitor the production and distribution process.
Expiry date: The intermediate packaging label must clearly state the expiry date of the drug. Information on the expiry date helps users know the last time the drug can be used safely and effectively. Compliance with the expiry date helps ensure that the drug does not lose its properties and does not cause harm to users after the prescribed time.

In addition, according to Clause 2, Article 8 of the above Circular, in cases where the intermediate packaging is a transparent material and the information printed on the packaging label in direct contact with the drug can be seen, it is not required to write the contents on the intermediate packaging label.

In summary, according to the provisions of Circular 01/2018/TT-BYT on intermediate packaging labels of drugs, intermediate packaging labels must include at least information on the drug name, production batch number and expiry date. This information helps users to identify, use and monitor drug products safely and effectively.

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Content that must be shown on the label of packaging in direct contact with drugs and pharmaceutical ingredients
According to the provisions of Article 9 of Circular 01/2018/TT-BYT on labels of packaging in direct contact with drugs and pharmaceutical ingredients, the mandatory contents that must be shown on the label of packaging are as follows:

Drug name: The label of packaging in direct contact with drugs must clearly state the name of the drug. This information helps users to identify and distinguish drug products accurately.
Quantitative composition, content, concentration or mass of pharmaceutical substances and medicinal herbs in the drug formula: The packaging label must clearly state the ingredients and data related to the quantification, content, concentration or mass of pharmaceutical substances and medicinal herbs in the drug formula. This information helps users understand the composition and dosage of the drug.
Batch number: The packaging label must clearly state the batch number of the drug. The batch number is important information for tracking and checking the origin, quality and expiry date of the drug.
Expiry date: The packaging label must clearly state the expiry date of the drug. Information about the expiry date helps users know the last time the drug can be used safely and effectively.
Name of the drug manufacturer: The packaging label must clearly state the name of the drug manufacturer. This information helps users know the origin and address of the drug manufacturer.
Labels of packaging in direct contact with medicinal ingredients
According to the provisions of Clause 2 of Article 9, in case the medicinal ingredients have outer packaging and have fully stated the contents as prescribed in Clauses 2 and 3 of Article 7, if they are not opened for retail sale, there is no requirement to label the direct packaging.

If the medicine or medicinal ingredient does not have outer packaging, according to Clause 3 of Article 9, the packaging in direct contact with the medicine or medicinal ingredient must fully state the contents of the outer packaging label as prescribed in Article 7 of this Circular.

What contents must be stated on the outer packaging label of traditional medicines?
The outer packaging label of traditional medicines must state the contents prescribed in Point a, Clause 1, Article 11 of Circular 01/2018/