Chương V Thông tư 11/2018/TT-BYT: Điều khoản thi hành

Chapter V

IMPLEMENTATION PROVISIONS

Article 17. Effect

1. This Circular is in effect from June 20, 2018.

2. The following documents shall be annulled on the date this Circular comes into effect:

a) The Minister of Health’s Circular No. 09/2010/TT-BYT dated April 28, 2010 providing guidance on drug quality management;

b) The Minister of Health’s Circular No. 04/2010/TT-BYT dated February 12, 2010 providing guidance on sample collection for quality identification.

Article 18. Implementation

1. The Drug Administration has the responsibility to:

a) Preside over and cooperate with related units in organizing propagation, dissemination and implementation of this Circular;

b) Preside over and cooperate with the National Institute of Drug Quality Control, the Institute of Drug Quality Control Ho Chi Minh City, the National Institute for Control of Vaccines and Biologicals in formulating plans to collect drug samples for quality inspection and present those plans to the Ministry of Health for consideration, approval and allocate budget for plan implementation within the Ministry’s competence.

Collect drug samples for quality inspection and update the Ministry of Health’s drug quality inspection database with information on collected drug/drug ingredient samples (including: name of drug/drug ingredient, concentration, content, type of preparation, batch number, expiry date, circulation registration number or import permit number, manufacturer, importer, sample collector) and the drug/drug ingredient’s quality inspection results;

c) Provide scientific and technical information on ensuring drug/drug ingredient quality.

Provide the National Institute of Drug Quality Control and the Institute of Drug Quality Control Ho Chi Minh City with label templates and the quality standard of the drug/drug ingredient that is issued circulation registration certificate or import permit (the updated standard if any changes occur). In the case of vaccines and biological, the label template and quality standard shall be sent to the National Institute for Control of Vaccines and Biologicals;

d) Organize quality inspections on drug/drug ingredients manufactured, prepared, circulated and used nationwide. Direct and survey the drug testing system nationwide. Draw conclusions on drug quality, based on the test results from state-owned drug testing facilities’ and relevant records;

dd) Preside over or participate in carrying out state inspections, inspect and take action against violations against the law in drug quality within the Administration's competence.

2. Departments of Health have the responsibility to:

a) Organize drug quality inspections within their jurisdictions and take actions against violations in accordance with the law;

b) Formulate plans to collect drug samples for quality inspection and present those plans to the provincial People’s Committees for consideration, approval and allocate budget for plan implementation within the Committees’ competence;

c) Update the Ministry of Health’s drug quality inspection database with information on collected drug/drug ingredient samples (including: name of drug/drug ingredient, concentration, content, type of preparation, batch number, expiry date, circulation registration number or import permit number, manufacturer, importer, sample collector) and the drug/drug ingredient’s quality inspection results.

3. Responsibilities of the drug testing system:

a) Central drug testing facilities (National Institute of Drug Quality Control, Institute of Drug Quality Control Ho Chi Minh City, National Institute for Control of Vaccines and Biologicals):

- Analyze and test samples to identify the quality of manufactured, circulated and used drugs/drug ingredients; report the test results to the Ministry of Health (Drug Administration) and the local Department of Health;

- Research, establish and publish on websites of the institute and the Drug Administration the list of reference materials (including those of impurities) for analyses and tests on manufactured, imported, circulated and used in Vietnam;

- The National Institute of Drug Quality Control and the Institute of Drug Quality Control Ho Chi Minh City have the responsibility to provide drug testing centers in assigned provinces with physical and electronic copies of drug/drug ingredient quality standards;

- The National Institute for Control of Vaccines and Biologicals, on an annual basis, review and evaluate vaccine/biological quality trends and present the evaluation to the Ministry of Health for consideration, and formation of guidelines for testing finished vaccines, biologicals which are antisera, derivatives of human blood and plasma (including reviewing vaccine/biological batch quality certificate’s test criteria).

Update information about quality certificate issuance for vaccines, biologicals which are antisera, derivatives of human blood and plasma on websites of the institute and the Drug Administration.

b) Provincial testing facilities:

- Analyze and test samples to identify the quality of manufactured, circulated and used drugs/drug ingredients;

- Report the test results to the Department of Health and the Ministry of Health (Drug Administration).

4. Traders have the responsibility to:

a) Organize researches and carry out implementation of the regulations of law on drug/drug ingredient quality promulgated by this Circular;

b) Implement regulations on inspection, control of drugs/drug ingredients’ source and quality. Carry out quality control in order to ensure drug/drug ingredient quality throughout the facility's operation;

c) Establish a system of records and documents in order to monitor circulation of drugs/drug ingredients. Carry out monitoring and surveillance of the quality of drugs/drug ingredients produced by the facility; timely discover and handle unconformable drugs, report those drugs to the pharmaceutical and drug quality inspection authorities.

5. When the drug quality inspection force has not yet been established at all levels, the Ministry of Health shall assign:

a) The National Institute of Drug Quality Control, the Institute of Drug Quality Control Ho Chi Minh City, the National Institute for Control of Vaccines and Biologicals, by their functions, tasks and jurisdictions, to:

- Formulate plans to collect drug samples for testing and surveillance of drug/drug ingredient quality; reserve, receive and use the annual budget for sample collection and tests on drug/drug ingredient samples;

- Collect drug/drug ingredient samples in accordance with the approved plans at establishments doing pharmacy business and using drugs;

- Update the Ministry of Health’s drug quality inspection database with information on drug/drug ingredient samples collected for quality inspection and those samples’ test results;

- Report the test results to the Ministry of Health (Drug Administration) and the local Department of Health if the drug/drug ingredient samples do not meet the quality standards as specified in Clause 3, Article 7 of this Circular.

- The National Institute of Drug Quality Control shall the drug quality inspection database for the Ministry of Health;

b) Provincial testing facilities:

- Formulate plans to collect drug samples for testing and surveillance of drug/drug ingredient quality; reserve, receive and use the annual budget for sample collection and tests on drug/drug ingredient samples;

- Collect drug/drug ingredient samples for quality inspection in accordance with the approved plans at establishments doing pharmacy business and using drugs;

- Update the Ministry of Health’s drug quality inspection database with information on drug/drug ingredient samples collected for quality inspection and those samples’ test results;

- Report the test results to the Ministry of Health (Drug Administration) and the Department of Health if the drug/drug ingredient samples do not meet the quality standards as specified in Clause 3, Article 7 of this Circular.

Article 19. Implementation responsibilities

The Director General of the Drug Administration, Chief of the Ministry Office, Chief Ministerial Inspector, heads of units affiliated with the Ministry of Health, provincial Departments of Health, pharmacy business establishments, other related authorities, organizations and individuals have the responsibility to implement this Circular.

If any complication arises during implementation, the authorities, organizations and individuals are advised to notify the Ministry of Health (Drug Administration) for consideration and solution.