Chương IV Thông tư 11/2018/TT-BYT: Quy định về thu hồi thuốc và xử lý thuốc vi phạm

Chapter IV

REGULATIONS ON RECALL AND HANDLING OF NONCONFORMABLE DRUGS

Article 12. Compulsory drug recall procedure

1. Receiving information on unconformable drugs:

The Ministry of Health (Drug Administration) receives information on unconformable drugs as follows:

a) Information on drugs that do not guarantee effective treatment or is unsafe from the drug registration advisory board or post-vaccination complication handling advisory board;

b) Information on drug quality criteria that are not met from drug testing facilities;

c) Information on discovered unconformable drugs from the Drug Administration, Health/Pharmaceutical inspection authority;

d) Unconformable foreign drug notices from manufacturers, pharmaceutical and drug quality inspection authorities;

dd) Information on unconformable drugs from public security, customs and market surveillance;

e) Drug information from pharmacy business establishments requesting voluntary drug recall.

2. Identification of the violation’s seriousness:

a) In 24 hours from the time the information on unconformable drugs mentioned in Points a, c, d, dd and e, Clause 1 of this Article, the Ministry of Health (Drug Administration) shall identify the violation’s seriousness and draw conclusions on drug recall, based on evaluation of consumer health's risks.

If the drug registration advisory board's opinion is requested for identification of the violation’s seriousness, as specified in Section IV, Appendix II issued together with this Circular, the time limit of identification of violation's seriousness will be 7 days.

b) The seriousness of a drug’s violation is specified in Appendix II issued together with this Circular;

c) For information on unconformable drugs mentioned in Point b, Clause 1 of this Article, the handling shall be carried out in accordance with Article 14 of this Circular.

3. Issuance of drug recall decision:

a) In 24 hours from the time the conclusion on drug recall is drawn, the Ministry of Health (Drug Administration) shall issue the drug recall decision in accordance with Clause 1, Article 65 of the Law on Pharmacy;

b) The drug recall decision must include the following information: drug name, circulation registration number or import permit number, name of active ingredient, concentration, content, form of preparation, batch number, expiry date, manufacturer, importer, recall level, the facility responsible for drug recall.

4. Notification of drug recall decision:

a) The drug recall decision of the Ministry of Health (Drug Administration) is announced by post, fax, email, telephone or the mass media. The scope of drug recall announcement is specified in Clause 3, Article 63 of the Law on Pharmacy;

b) Immediately after making the recall decision, the Ministry of Health (Drug Administration) announces the drug recall decision on websites of the Ministry of Health and the Drug Administration, and the Ministry of Health’s national pharmaceutical database;

Departments of Health announce drug recall decisions on their websites immediately after receiving those decisions.

Domestic drug manufacturers and importers must notify the information about recalled drugs to drug traders/users which purchased those drugs.

c) For recalling drugs with first-degree violations, besides carrying out the actions specified in Point b of this Clause, the Ministry of Health must announce the drug recall decision on Vietnam Television and Voice of Vietnam.

5. Recalling drugs:

a) The drug trader/user must discontinue provision and use of the recalled drugs; place inventory drugs in quarantine; make a list of drug traders/users and individuals (if any) that purchased those drugs, contact them and receive the returned drugs; return the drugs to the providers;

b) The manufacturer (of domestic drugs) and importer cooperate with the import entrustor or distribution hub (of imported drugs) in recalling unconformable drugs. The recall form follows Template No. 4 of Appendix III issued together with this Circular.

The drug trader/provider that fails to recall drugs or receiving returned drugs shall be notified by facilities and individuals purchasing those drugs to the local Department of Health and face actions.

c) Drug recall has to be completed within one of the time limits specified in Clause 3, Article 63 of the Law on Pharmacy.

6. Drug recall report, evaluation and additional measures:

a) In one day (for first-degree recalls) or three days (for second- and third-degree recalls) from the recall’s date of completion, the facility in charge of recalling must report the results to the Ministry of Health (Drug Administration) and the local Department of Health in writing. The report consists of the following documents:

- Summary drug recall report, which follows Template No. 5 of Appendix III issued together with this Circular.

- List of drug traders/users (including those receiving drugs from the facility in charge of recalling unconformable drugs, or from distributors) with their addresses, phone numbers, email addresses (if any), amount of drugs received, amount of drugs recalled;

- Delivery reports, receipts of return or other evidence of drug recall;

- Drug recall self-evaluation form;

- Investigation results, evaluation of causes, evaluation of risks in the unconformable drug's other batches and/or other drugs coming from the same production line.

b) The Ministry of Health (Drug Administration) consider the report mentioned in Point a of this Clause, evaluate it or send it to the Department of Health for evaluation. If the drug recall is evaluated to be insufficient and the product can still be circulated and used, posing a risk to the consumers' health, the Drug Administration cooperates with the Department of Health and other related authorities in coercive drug recall.

Article 13. Voluntary drug recall procedure

1. The pharmacy business establishment that carries out voluntary drug recall shall evaluate and identify the seriousness of the drug's violation and report on the unconformable drug, seriousness of violation, reason for recall and handling measure proposal to the Ministry of Health (Drug Administration) in writing, as specified in Clauses 3 and 4, Article 15 of this Circular.

2. In three days from the date the pharmacy business establishments’ report is received, the Ministry of Health (Drug Administration) consider the report and identify the seriousness of the drug's violation as specified in Appendix II issued together with this Circular.

a) If an agreement with the pharmacy business establishment’s proposal concerning the drug with third-degree violation is reached, the Ministry of Health (Drug Administration) shall send an document allowing the facility to voluntarily recall the drug.

b) In the case of drugs with first- or second-degree violations, the Ministry of Health (Drug Administration) shall follow the drug recall procedures mentioned in Clauses 3, 4, 5 and 6, Article 12 of this Circular;

c) If additional information or clarification of information in the pharmacy business establishment’s report is needed, the Ministry of Health (Drug Administration) shall request the establishment to provide additional information and explanations in writing. In five days from the day the Ministry of Health’s request is received, the establishment must provide additional information and explanations in writing.

3. In 24 hours from the time the Ministry of Health (Drug Administration ) issues the document allowing voluntary drug recall, the establishment can issue the drug recall decision, notify it to traders/users and carry out drug recall as specified in Clauses 5 and 6, Article 12 of this Circular.

Article 14. Handling of drugs not meeting quality standards by place of collection

1. In the case of unconformable drug samples collected from retailers, level-III and level-IV medical facilities:

a) In 24 hours from the time the testing facility’s test/analysis report is received, the Department of Health shall seal the unconformable drug at the sample’s facility of origin.

b) In 48 hours from the time the testing facility’s test/analysis report is received, the Ministry of Health (Drug Administration) shall request the responsible drug registrant/manufacturer/importer to:

- Report its drug distribution to the Ministry of Health (Drug Administration);

- Request the quality inspection authorities to collect additional samples from domestic drug manufacturers or importers, and from at least two wholesalers, with one of them already supplied drugs to the facility where the samples are collected from;

- Send samples to central testing facilities in order to have the unfulfilled criteria tested.

c) If at least one of the additional sample does not meet the quality standards, the Ministry of Health (Drug Administration) shall identify the violation’s seriousness and draw the conclusion on recalling the unconformable drug as specified in Appendix II issued together with this Circular, and issue the drug recall decision as specified in Clause 3, Article 12 of this Circular. The recall's scope and time limit is specified in Clause 3, Article 63 of the Law on Pharmacy;

d) If all of the additional samples meet the quality standards, the Ministry of Health (Drug Administration) shall only carry out the steps of identifying the violation’s seriousness, drawing the conclusion on recalling the unconformable drug, issuing the drug recall decision and drug handling to the drugs of the facility providing the initial samples.

2. In the case of unconformable drug samples collected from wholesalers, level-II or above medical facilities:

a) In 24 hours from the time the testing facility’s test/analysis report is received, the Department of Health shall seal the unconformable drug at the facility of origin.

b) In 48 hours from the time the testing facility’s test/analysis report is received, the Ministry of Health (Drug Administration) shall issue the drug recall decision applying to the province the facility of origin is based on and traders/users receiving the drug from that facility, as specified in Clause 3, Article 12 of this Article, and request the responsible trader/user/importer to:

- Report its drug distribution to the Ministry of Health (Drug Administration);

- Request the quality inspection authorities to collect at least two additional samples from other wholesale establishments, with one of them already supplied drugs to the facility where the samples are collected from;

- Send samples to central testing facilities in order to have the unfulfilled criteria tested.

c) If at least one of the additional sample does not meet the quality standards, the Ministry of Health (Drug Administration) shall identify the violation’s seriousness and draw the conclusion on recalling the unconformable drug as specified in Appendix II issued together with this Circular, and issue the drug recall decision as specified in Clause 3, Article 12 of this Circular. The recall's scope and time limit is specified in Clause 3, Article 63 of the Law on Pharmacy;

d) If all of the additional samples meet the quality standards, the Ministry of Health (Drug Administration) shall only carry out the process specified in Point b of this Clause.

3. If the sample is collected from manufacturers, importers and preservation service providers, or the sample's quality violation is identified to be caused by the production process, the Ministry of Health (Drug Administration) shall identify the violation’s seriousness and draw the conclusion on recalling the unconformable drug as specified in Appendix II issued together with this Circular, and issue the drug recall decision as specified in Clause 3, Article 12 of this Circular. The recall's scope and time limit is specified in Clause 3, Article 63 of the Law on Pharmacy.

Article 15. Handling of recalled drugs

1. The recalled drug can either be rectified or re-exported if it has third-degree violation and does not fall into the type of drug mentioned in  Point b, Clause 2 of this Article.

2. The recalled drug must be destroyed if it has:

First- or second-degree violation;

b) Third-degree violation, considered by the Ministry of Health (Drug Administration) to be neither rectifiable nor re-exportable, as specified by Clauses 3 and 4 of this Article;

c) Third-degree violation, considered by the Ministry of Health (Drug Administration) to be rectifiable or re-exportable, but the facility fails to rectify or re-export that drug.

3. Procedure for proposing rectification of recalled drugs:

a) The facility that has recalled drugs shall send the Ministry of Health (Drug Administration) a document stating the rectification process, drug quality and stability risk assessment, the program for monitoring and surveillance of the drug’s quality, safety and efficacy during circulation.

b) In 60 days from the date the facility’s rectification proposal is received, the Ministry of Health (Drug Administration) must consider the proposal and reply their agreement or disagreement in writing The reason for disagreement must be specified;

c) If additional information or clarification of the rectification's information is required, in 60 days from the date the Ministry of Health’s (Drug Administration) document is received, the facility must provide documents additional information and explanations. Failure to do so within the aforementioned time limit will result in invalidation of the rectification proposal.

4. Procedure for proposing re-export of recalled drugs:

a) The facility that has recalled drugs shall send the Ministry of Health (Drug Administration) a document with the re-export plan, stating the time and re-export country;

b) In 15 days from the date the facility’s proposal is received, the Ministry of Health (Drug Administration) shall reply their agreement or disagreement on the re-export in writing; the reason for disagreement must be specified.

5. The rectification and re-export of recalled drug shall only be carried out after the written agreement of the Ministry of Health (Drug Administration) is issued.

6. Drug destruction:

a) The head of the facility that has drugs to be destroyed shall decide to form the drug destruction council. The council shall have at least three persons, with one representative having professional responsibility;

b) Drug destruction must be safe for both humans and animals, does not pollute the environment in accordance with the rules of law in environmental protection;

c) Drug destruction that requires special control must be carried out as specified in Article 48 of Decree No. 54/2017/ND-CP;

d) The facility carrying out drug destruction must notify the Department of Health, and send the Department a drug destruction form that follows Template No. 6 in Appendix III issued together with this Circular.

7. The recalled drug handling period shall not exceed 12 months from the recall’s date of completion, as specified in Points a, b and c, Clause 3, Article 63 of the Law on Pharmacy.

Article 16. Responsibilities for drug recall

1. Responsibilities of pharmacy business establishments, medical facilities and drug users:

a) Comply with the regulations in Clauses 1, 2 and 3, Article 64 of the Law on Pharmacy;

b) Regularly review and update information on drug recall from websites of the Ministry of Health, the Drug Administration, and Departments of Health.

2. Responsibilities of the Drug Administration:

a) Receive information, identify seriousness of drug’s violations and issue drug recall decisions;

b) Announce drug recall decisions as specified in Point a, Clause 4, Article 12 of this Circular, publish information about recalled drugs on websites of the Ministry of Health and the Drug Administration after those decisions are issued. Cooperate with Vietnam Television and Voice of Vietnam in announcing recall of drugs with first-degree violations;

c) Consider the evaluation reports and reply to the pharmacy business establishments’ proposals for voluntary drug recall, rectification or re-export of recalled drugs;

d) Cooperate with related units (Ministerial Inspector, Department of Health, health divisions of other agencies) in inspection of organization and execution of drug recall; take actions against violating facilities in accordance with the regulations of law;

dd) Produce documents providing detailed guidelines for the processes of drug recall and handling, evaluation of drug recall in drug manufacturers and pharmacy business establishments.

3. Responsibilities of Departments of Health:

a) Publish drug recall decisions on websites of the Departments of Health;

b) Organize announcement and dissemination of drug recall information to local drug manufacturers, pharmacy business establishments and medical facilities;

c) Cooperate with facilities having drugs with quality violations in collecting additional drug samples as specified in Point b, Clause 1 or Point b, Clause 2, Article 14 of this Circular, or direct the testing facilities to do so;

d) Organize surveillance of drug recall in the Departments’ jurisdictions; take actions against and penalize facilities violating drug recall regulations within their competence;

dd) Participate in or carry out evaluations of pharmacy business establishments’ drug recall in the Departments’ jurisdictions, under the Ministry of Health’s (Drug Administration’s) direction. Report any drug manufacturer, importer, wholesalers which are distribution hubs that fail to, or insufficiently, recall drugs to the Ministry of Health (Drug Administration)

e) Organize and participate in coercive drug recall.