Medicines must be destroyed when they expire, are damaged during production, storage, transportation...
This Circular provides detailed guidance on the application of drug quality standards (chemical drugs, herbal drugs, vaccines, biological products), drug ingredients (except herbal drugs, traditional medicines); testing of drugs, herbal ingredients, packaging in direct contact with drugs and procedures for recalling and handling violating drugs.
Mandatory drug recall process
The Circular stipulates the procedure for mandatory drug recall as follows:
1- Receiving information about drug violations from the Ministry of Health (Department of Drug Administration)
Information on drug evaluation does not guarantee treatment effectiveness and safety from the Drug Registration Advisory Council or the Advisory Council on handling post-vaccination adverse events. Information on drug quality failure from drug testing facilities.
Information on drug violations detected by the Drug Administration and Inspection Agency. Notification of drug violations by manufacturing facilities, management agencies, and foreign state drug quality inspection agencies.
Information on illegal drugs (including counterfeit drugs and drugs of unknown origin) discovered by police, customs, and market management agencies.
2- Receiving information about drug violations from the Department of Health of provinces and centrally-run cities
Information about substandard drugs from drug testing facilities.
Information on drug violations detected by the Drug Administration and Inspection Agencies in the area.
Information on illegal drugs (including counterfeit drugs and drugs of unknown origin) discovered by police, customs, and market management agencies in the province or city.
3- Determine the level of violation
Within 24 hours from the time of receiving information about the violating drug, the Ministry of Health (Department of Drug Administration) and the Department of Health shall determine the level of violation of the drug and conclude on the recall of the violating drug based on the assessment of the risk to the health of the user, including in the case of complaints about the test results.
4- Handling of drugs in violation of the Department of Health in the area
Within 24 hours from the time of receiving information about the violating drug, the Department of Health shall compare the level of violation of the drug as prescribed in Appendix II issued with this Circular and issue a document to handle and recall the drug in the area for level 2 or level 3 violating drugs as prescribed in Article 14 of this Circular.
Check, monitor drug recall and sample collection to check drug quality in the area.
5- Handling of the Ministry of Health (Department of Drug Administration) for violating drugs:
Within no more than 24 hours from the time of conclusion on drug recall for violations as prescribed in Clause 1, Article 65 of the Law on Pharmacy, the Ministry of Health (Department of Drug Administration) shall issue a decision to recall the drug.
The recall decision must include the following information (if any): drug name, circulation registration number or import license number, active ingredient name, concentration, content, dosage form, batch number, expiry date, manufacturing facility, importing facility, recall level, facility responsible for recalling the drug.
Drugs recalled according to the recall decision issued by the Ministry of Health (Department of Drug Administration) are identified as a drug batch or multiple drug batches or all drug batches of one or more drugs.
6- Notice of drug recall decision.
7- Implement drug recall.
Handling of illegal drugs
According to the Circular, violating drugs are allowed to be remedied or re-exported in the following cases:
- Drugs that violate level 3 and are not subject to the provisions of Points d and e, Clause 1, Article 17 of this Circular (Drugs that are recalled due to level 3 violations, are reviewed by the Ministry of Health (Department of Drug Administration) according to regulations and conclude that they cannot be remedied or re-exported; drugs that are recalled due to level 3 violations are permitted by the Ministry of Health (Department of Drug Administration) to be remedied or re-exported but the facility cannot remediate or re-export).
- Drugs that violate regulations on labeling and instructions for use.
- Medicines packaged in outer packaging from component medicines packaged in different direct packaging (kits) in which one or more component medicines do not meet quality standards. Based on the level of violation of the component medicine, this component medicine is allowed to be recycled, re-exported or destroyed according to regulations. Other components that meet quality standards are allowed to be recycled and repackaged appropriately.
The facility whose drug is recalled must submit a written request to the Ministry of Health (Department of Drug Administration) with a procedure for remedying the problem, an assessment of the risks to the quality and stability of the drug, and a program to monitor and supervise the quality, safety and effectiveness of the drug during circulation.
Within a maximum of 60 days from the date of receipt of the facility's request for correction, the Ministry of Health (Department of Drug Administration) must review and respond in writing with approval or disapproval of the correction. In case of disapproval, the reasons must be clearly stated.
In case of need to supplement or clarify information related to the correction, within a maximum period of 60 days from the date of receipt of the document from the Ministry of Health (Department of Drug Administration), the facility must submit additional documents and explanations. After the above period, if the facility does not submit additional documents and explanations, the request for correction is no longer valid.
Facilities with recalled drugs or drugs in violation must send a document to the Ministry of Health (Department of Drug Administration) with a re-export plan clearly stating the time and country of re-export.
Within a maximum period of 15 days from the date of receipt of the facility's request, the Ministry of Health (Department of Drug Administration) shall respond in writing agreeing or disagreeing with re-export; in case of disagreement, the reason must be clearly stated.
The remediation and re-export of recalled drugs can only be carried out after receiving written consent from the Ministry of Health (Department of Drug Administration).
Discard the medicine
1- Medicines must be destroyed in one of the following cases:
a) Expired drugs; b) Drugs damaged during production, storage, or transportation; c) Drugs whose storage period has expired according to regulations; d) Drugs recalled due to level 1 or level 2 violations; e) Drugs recalled due to level 3 violations, reviewed by the Ministry of Health (Department of Drug Administration) according to regulations and concluded that they cannot be remedied or re-exported;
e) Drugs recalled due to level 3 violations are permitted by the Ministry of Health (Department of Drug Administration) to be remedied or re-exported but the facility fails to remedy or re-export; g) Counterfeit drugs, smuggled drugs, drugs of unknown origin, drugs containing banned substances; h) Drugs that must be destroyed according to the provisions of the Decree on administrative sanctions in the health sector; i) Drugs produced from raw materials that do not meet quality standards, except in cases where the failure to meet the standards is handled during the production process and does not affect the production process and drug quality.
2- Destroying drugs at manufacturing, importing, wholesaling facilities, drug testing facilities, hospitals, and institutes with beds:
The head of the drug manufacturing, importing, wholesaling, testing facility, hospital, or institute with beds containing drugs to be destroyed shall decide to establish a Drug Destruction Council to organize the destruction of drugs, decide on the destruction method, and supervise the destruction of drugs. The Council shall have at least 03 members, of which 01 representative must be the professional in charge of the facility.
Drug disposal must ensure safety for people and animals and avoid environmental pollution according to regulations of law on environmental protection.
The facility whose drugs are destroyed must take full responsibility for the destruction of the drugs. A report with a record of drug destruction must be sent to the local Department of Health for cases of drug destruction. The record of drug destruction must comply with the regulations in Form No. 06 of Appendix III issued with this Circular.
3- Regulations on vaccine cancellation
At least 07 working days before destroying vaccines, the facility whose vaccines are to be destroyed must send a written notice of the destruction plan to the local Department of Health, which must include information on the name, quantity, concentration or content of each vaccine to be destroyed, the reason for destruction, the time of destruction, the location of destruction and the method of destruction. The Department of Health is responsible for supervising the destruction of vaccines.
The procedure for destroying vaccines and the destruction of vaccines must be carried out in accordance with current regulations on medical waste management and hazardous waste management. The facility whose vaccines are destroyed must report in writing the destruction of vaccines along with the destruction record to the local Department of Health and the Drug Administration. The vaccine destruction record is in accordance with Form No. 06, Appendix III, issued with this Circular.
4- The destruction of drugs subject to special control must comply with the provisions of Article 37 of Decree No. 163/2025/ND-CP.
5- Drug destruction at retail establishments and medical clinics: Drug destruction is carried out according to a contract with a facility that is responsible for industrial waste treatment.
The person in charge of the retail establishment's professional activities and the head of the medical clinic are responsible for drug destruction, supervising drug destruction, and storing documents on drug destruction.
6- The time limit for handling recalled drugs shall not exceed 12 months from the time of completion of the recall as prescribed in points a, b and c, Clause 3, Article 63 of the Law on Pharmacy.
Minh Hien
Source: https://baochinhphu.vn/huong-dan-thu-hoi-xu-ly-thuoc-vi-pham-102250703152836291.htm
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