On July 4, the Ministry of Health issued Circular No. 30/2025/TT-BYT detailing the application of quality standards, testing and the process of recalling, treating and destroying violating drugs. The Circular updates many regulations related to the management of drug quality, pharmaceutical ingredients and ensuring safety in handling violating drugs.
According to the instructions, drugs will be destroyed in the following cases: expired, damaged in production, transportation, and storage; circulating samples have expired; drugs recalled due to violations at levels 1 and 2 and level 3 drugs but cannot be remedied or re-issued; counterfeit, smuggled drugs, drugs of unknown origin, drugs containing banned substances; drugs subject to destruction according to administrative sanctions; drugs produced from materials that do not meet standards but cannot be treated to ensure quality.
The decision to cancel the drug at the drug manufacturing, importing, wholesale, testing facilities, and hospitals will be decided by the head of the facility to establish a Drug Cancellation Council. This council has at least three members, including a professional representative and will decide on the method of canceling and supervising the entire destruction process. The cancellation of drugs must ensure the safety of people and animals and not cause environmental pollution, complying with legal regulations on environmental protection. After destruction, the facility is responsible for preparing a report with a record and sending it to the local Department of Health according to the prescribed form.
For vaccines, the cancellation process is more strictly controlled. At least 7 working days before the destruction, the facility must have a written notice of the cancellation plan sent to the local Department of Health, clearly stating the name, quantity, concentration or content of each vaccine, reason, time, location and method of cancellation. The cancellation of vaccines must comply with regulations on the management of medical waste and hazardous waste and be supervised by the Department of Health. After completion, the facility must prepare a report with a destruction report to the Department of Health and the Department of Drug Administration.
For drugs that must be subject to special control, the cancellation process will be carried out according to Article 37 of Decree 163/2025/ND-CP. At drug retail facilities and treatment clinics, the cancellation of drugs must sign a contract with a unit with the function of treating industrial waste. The person responsible for the expertise at these facilities must supervise and maintain complete records of destruction.
The Circular also stipulates that the processing period for recalled drugs must not exceed 12 months from the date of completion of the recall, ensuring the provisions of the Pharmacy Law.
With detailed instructions, the Ministry of Health hopes to strengthen control of drug quality, ensure safety for the community and prevent the situation of fake drugs and poor quality drugs circulating on the market.
