On November 30, 2023, the Ministry of Health issued Circular No. 23/2023/TT-BYT ("Circular 23") amending and supplementing certain provisions of Circular No. 01/2018/TT-BYT regarding drug labeling, raw materials for drug production, and drug use instructions. Accordingly, ATA has updated some noteworthy contents as follows:
1. Supplementing some cases regarding the position of drug labels and drug use instructions
As per regulations, all drug labels must be displayed on the drug and its packaging. The drug use instructions are an inseparable part of the drug label, contained within the outer packaging of the drug. However, Circular 23 allows the relocation of drug labels and drug use instructions in certain cases:
- For radiopharmaceuticals: Labels and drug use instructions are not required to be attached to the commercial packaging but may be provided to the treatment facility along with the drug delivery records or affixed to the packaging used for drug storage, transportation, and preservation.
- For imported drugs with registration certificates urgently issued for national defense, security, epidemic prevention, and disaster relief: Drug use instructions may be attached to the outer packaging.
2. Principles for supplementing or replacing drug use instructions in Vietnam
a. Cases, where drug use instructions in Vietnamese, are supplemented or replaced after customs clearance:
- Imported drugs with a registration certificate for circulation in Vietnam that already have Vietnamese drug use instructions on the packaging but have not updated the content according to the Ministry of Health's requirements, except for cases where drug use instructions are not required.
- Imported drugs without a registration certificate for circulation in Vietnam, and the packaging does not have drug use instructions in Vietnamese, except for cases where drug use instructions are not required.
- Imported drugs already granted a registration certificate by the Ministry of Health in urgent cases for national defense, security, epidemic prevention, and disaster relief, and the packaging does not have drug use instructions in Vietnamese.
b. Implementation location:
According to previous regulations, supplementing or replacing drug use instructions in Vietnamese was carried out at the secondary packaging department (secondary packaging) of the facility complying with Good Manufacturing Practice (GMP) principles within the scope of the Certificate of Pharmaceutical Business Conditions. Circular 23 clarifies this as follows:
- The supplementation or replacement of drug use instructions in Vietnamese only needs to be performed at the secondary packaging department (secondary packaging) of the facility that meets GMP principles (meaning facilities only need to have GMP criteria) within the scope of the Certificate of Pharmaceutical Business Conditions.
- For drug use instructions attached to the direct-contact packaging of the drug in the above cases, the supplementation/replacement of drug use instructions must be carried out at the packaging department of the facility that meets GMP principles (i.e., facilities that have been granted a GMP certificate) or the drug storage warehouse, raw material warehouse meeting the principles, GSP standards before releasing the drug to the market.
3. Supplementing barcode information displayed on drug labels
According to Circular 23, in addition to the mandatory information displayed on drug labels before the drug is released to the market, organizations and individuals responsible for the drug are allowed to add other contents on the drug label, including barcode, QR code, DataMatrix Code (DMC), or suitable code on the drug label to implement electronic drug usage guidance retrieval. This additional provision facilitates users in easily accessing information about the purpose and usage of the drug.
Circular 23 takes effect from January 15, 2024.
For drug labels and drug use instructions in the application, extension, modification, and supplementation of registration certificates submitted before the effective date of Circular 23 but still, in the process of being resolved, they will follow the regulations at the time of submission. However, no later than January 1, 2025, drug labels and drug use instructions must comply with the provisions of Circular 23 before the drug is released to the market.
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