Regulations on handling complaints about drug quality in the medical field

Article 10 of Decision 44/2005/QD-BYT stipulates the settlement of complaints about drug quality in the medical field as follows:

1. Verification

1.1. For the complainant:

- Verify the content of the complaint;

- Request to provide evidence: Drug purchase invoice, drug sample; name and address of drug selling facility.

1.2. Verification at relevant units and individuals:

1.2.1. Check at drug retail establishments:

- Legal basis;

- Human resources;

- Invoice for purchase and sale of drugs;

- Physical conditions of retail establishments;

- Implementation of drug quality management regulations;

- Take drug samples for testing (if necessary).

1.2.2. Check at distributor:

- Legal basis;

- Human resources;

- Invoice for purchase and sale of drugs;

- Drug batch testing certificate;

- Implementation of drug quality management regulations;

- Drug storage;

- Take drug samples for testing (if necessary).

1.2.3. Check at manufacturer:

- Legal basis;

- Human resources;

- Drug registration dossier;

- Production batch records;

- Check at the production facility;

- Implementation of drug quality management regulations;

- Quality of stored drug samples;

- Take drug samples for testing (if necessary).

1.2.4. Check at importer:

- Legal basis;

- Human resources;

- Import registration documents;

- Foreign contracts;

- Drug test certificate;

- Implementation of drug quality management regulations;

- Take drug samples for testing (if necessary).

1.3. Request for drug quality inspection (if necessary):

- At the local level, the agencies requested for testing are the pharmaceutical and cosmetic testing centers of the provinces and centrally run cities.

- At the central level, the agencies requested for testing are the Testing Institute and the Ho Chi Minh City Testing Sub-Institute. In which, the testing conclusion of the Testing Institute is the final conclusion.

- Drug sampling for testing must be carried out according to correct procedures and must be performed by a competent authority.

1.4. Testing fees are implemented according to current regulations.

2. Conclusion

Based on the verification results, drug quality testing results, and legal regulations, it is concluded that:

- Medicines meet quality standards;

- The drug does not meet quality standards, if the criteria are clearly stated and the standards for reference.

- Responsibilities of agencies, organizations and individuals related to drugs that do not meet quality standards.

3. Recommendations

Based on the verified results, conclude the incident to make recommendations to the competent authority to resolve the complaint:

- If the complaint is correct (medicine is of poor quality), propose to handle the violating agencies, organizations and individuals according to the provisions of Decree 45/CP dated June 4, 2004 of the Government on administrative sanctions for violations in the state sector of health and other relevant legal provisions; propose to handle the exhibits according to regulations. In case the violation shows signs of constituting a crime, the file must be transferred to the investigation agency according to regulations.

- If the complaint content is incorrect (the drug meets quality standards according to regulations), we recommend rejecting the complaint.

4. The competent authority issues a decision to resolve the complaint.