Instructions for recalling and handling violating drugs

Instructions for recalling and handling violating drugs - Photo 1.

Medicines must be destroyed when they have expired or are damaged during production, storage, transportation, etc.

This Circular provides detailed guidance on the application of drug quality standards (chemical drugs, herbal drugs, vaccines, biological products), drug ingredients (except herbal drugs and traditional medicines); testing of drugs, pharmaceutical ingredients, packaging in direct contact with drugs and procedures for recalling and handling violating drugs.

Compulsory drug recall process

The Circular stipulates the procedure for compulsory drug recall as follows:

1- Receiving information about drug violations from the Ministry of Health (Drug Administration Department)

Information on drug evaluation does not guarantee treatment effectiveness and safety from the Drug Registration Advisory Council or the Advisory Council on handling adverse events after vaccination. Information on drug quality does not meet standards from drug testing facilities.

Information on drug violations discovered by the Drug Administration and Inspection Agencies. Notification of drug violations by manufacturing facilities, regulatory 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 on substandard drugs from drug testing facilities.

Information on drug violations discovered 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 the Department of Health for drug violations 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 sampling 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 concluding the 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, and 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 many 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 do not fall under 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 (Drug Administration) according to regulations and concluded that they cannot be remedied or re-exported; drugs that are recalled due to level 3 violations are permitted by the Ministry of Health (Drug Administration) to be remedied or re-exported but the facility cannot remedy 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) for correction, along with a procedure for correction, assessment of 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 period of 60 days from the date of receipt of the facility's written 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 needing 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 will no longer be 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 with approval or disapproval of re-export; in case of disapproval, the reasons 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 medication

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 person in charge of the facility's expertise.

Drug disposal must ensure safety for people and animals and avoid environmental pollution according to environmental protection laws.

The facility whose drugs are destroyed must take full responsibility for the destruction of the drugs. A report with a drug destruction record must be sent to the local Department of Health for cases of drug destruction. The drug destruction record 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 the 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 the 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 vaccine destruction process and vaccine destruction 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 the vaccine destruction in writing, 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 facility's professional duties 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 date 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