Chương VI Thông tư 13/2018/TT-BYT: Điều khoản thi hành

Chapter VI

IMPLEMENTATION PROVISIONS

Article 21. Entry into force

1. This Circular comes into force from June 30, 2018.

2. The following documents shall be abrogated from the date of entry into force of this Circular:

a) Regulations on quality of herbal ingredients and traditional drugs of the Circular No. 09/2010/TT-BYT dated April 28, 2010 by Minister of Health providing guidelines for management of drug quality;

b) The Circular No. 05/2014/TT-BYT dated February 14, 2014 by Minister of Health on application of herbal ingredients and traditional ingredients in health facilities.

Article 22. Terms of reference

If legislative documents referred to herein are superseded or amended, the new ones shall apply.

Article 23. Implementation organization

1. The Traditional Medicine Administration of Vietnam has the responsibility to:

a) Take charge and cooperate with relevant agencies to disseminate and organize the implementation of this Circular;

b) Take charge and cooperate with the National Institute of Drug Quality Control and the Institute of Drug Quality Control of Ho Chi Minh City in:

- Formulating the plan for sampling of herbal ingredients and traditional drugs for testing their quality, submitting the plan to the Ministry of Health for considering giving approval, and allocating budget for implementing the plan intra vires;

- Organizing sampling of herbal ingredients and traditional drugs for testing their quality and updating the drug quality information system of the Ministry of Health with information concerning samples taken (including name of traditional drug, name of herbal ingredient, concentration/ content, dosage form, batch number, expiry date, registration number or import license number, manufacturer, importer or establishment where samples are taken) and quality testing results;

c) Provide the National Institute of Drug Quality Control and the Institute of Drug Quality Control of Ho Chi Minh city with specimens of labels and standards for quality of herbal ingredients/ traditional drugs granted certificate of free sale or import license, and adjusted ones, if any.

d) Conduct inspection of quality of herbal ingredients and traditional drugs manufactured, prepared and sold nationwide; instruct and supervise testing facilities taking charge of testing herbal ingredients and traditional drugs nationwide; reach conclusions about quality of herbal ingredients and traditional drugs based on testing reports given by state-owned testing facilities and relevant documents; organize recall of herbal ingredients failing to meet quality standards in accordance with regulations in Article 102 of the Government's Decree No. 54/2017/ND-CP dated May 08, 2017;

dd) Take charge or cooperate in performing state inspection and handling violations against regulations on quality of herbal ingredients and traditional drugs intra vires;

e) Consolidate reports on use of herbal ingredients and traditional drugs nationwide by December 30 of every year;

g) Update its website with the list of establishments making commitments to sites where herbal ingredients are cultivated and harvested.

2. Each Provincial Department of Health has the responsibility to:

a) Conduct inspection of quality of herbal ingredients and traditional drugs in the province and take actions against violations according to law regulations;

b) Formulate the plan for sampling of herbal ingredients and traditional drugs for testing their quality, submitting the plan to the Provincial People’s Committee for considering giving approval, and allocating budget for implementing the plan intra vires;

c) Update the drug quality information system of the Ministry of Health with information concerning samples of herbal ingredients and traditional drugs taken (including name of traditional drug, name of herbal ingredient, concentration/ content, dosage form, batch number, expiry date, registration number or import license number, manufacturer, importer or establishment where samples are taken) and quality testing results.

d) Collect information and update its website with the list of locations and establishments growing, harvesting and extracting herbs in the province.

3. Responsibility of herbal ingredient and traditional drug testing facilities:

a) Central-level testing facilities (including the National Institute of Drug Quality Control and the Institute of Drug Quality Control of Ho Chi Minh city) shall:

- Carry out analysis and testing of samples so as to determine the quality of herbal ingredients and traditional drugs manufactured, sold and used; send testing reports to the Ministry of Health (via the Traditional Medicine Administration of Vietnam) and the Department of Health of province where samples are taken if samples of herbal ingredients and traditional drugs fail to meet quality standards under the provisions of Article 10 herein;

- Do research, establish and publish on their websites and the website of the Traditional Medicine Administration of Vietnam the list of reference standards, reference substances and impurity reference substances used for analysis and testing of samples of herbal ingredients and traditional drugs manufactured, imported, sold and used in the territory of Vietnam;

- Provide testing centers of provinces and central-affiliated cities as assigned with the copies or electronic files of quality standards of herbal ingredients and traditional drugs.

b) Testing centers of provinces and central-affiliated cities shall:

- Conduct analysis and testing of samples so as to determine the quality of herbal ingredients and traditional drugs manufactured, sold and used;

- Send testing reports to the Provincial Department of Health and the Ministry of Health (via the Traditional Medicine Administration of Vietnam) if samples of herbal ingredients and traditional drugs fail to meet quality standards under the provisions of Article 10 herein.

4. Establishments trading in herbal ingredients and traditional drugs shall:

a) Comply with regulations on quality of herbal ingredients and traditional drugs herein;

b) Ensure quality of their herbal ingredients and traditional drugs; manage quality of herbal ingredients and traditional drugs according to the licensed scope of business and in compliance with law regulations;

c) Preserve imported herbal ingredients and traditional drugs at warehouses meeting Good Storage Practice requirements after being granted customs clearance;

d) Regularly report and provide documents proving the origins of herbal ingredients to the Traditional Medicine Administration of Vietnam for publishing on its website;

dd) Separately store counterfeit herbal ingredients/ traditional drugs when discovering, trace back to their origins and inform competent quality inspection agencies and other traders.

5. While herbal ingredient/ traditional drug quality controllers are not assigned at all levels, the Ministry of Health shall:

a) Assign the National Institute of Drug Quality Control and the Institute of Drug Quality Control of Ho Chi Minh city, within the ambit of assigned functions, duties and scope of operation, to:

- Formulate the plan for sampling of herbal ingredients and traditional drugs for testing quality; estimate and receive annual budget allocated for cover testing expenses;

- Take samples of herbal ingredients and traditional drugs according to the approved plan;

- Establish and develop the herbal ingredient and traditional drug quality information system of the Ministry of Health. Update their websites with information concerning samples of herbal ingredients and traditional drugs taken for quality testing and testing results;

- Send testing reports to the Ministry of Health (via the Traditional Medicine Administration of Vietnam) and the Department of Health of province where samples are taken if samples of herbal ingredients and traditional drugs fail to meet quality standards under the provisions of Article 10 herein.

b) Assign testing centers of provinces and central-affiliated cities to:

- Formulate the plan for sampling of herbal ingredients and traditional drugs for testing quality; estimate and receive annual budget allocated for cover testing expenses;

- Take samples of herbal ingredients and traditional drugs for testing their quality according to the approved plan;

- Update their websites with information concerning samples of herbal ingredients and traditional drugs taken for quality testing and testing results;

- Send testing reports to the Ministry of Health (via the Traditional Medicine Administration of Vietnam) and Provincial Departments of Health if samples of herbal ingredients and traditional drugs fail to meet quality standards under the provisions of Article 10 herein.

6. Health facilities have the responsibility to:

a) Use and apply herbal ingredients and traditional drugs that have clear origins as prescribed in Article 14 herein and are supplied by establishments granted certificate of eligibility to trade herbal ingredients and traditional drugs;

b) Carry out periodic inspection or unexpected inspection of quality of herbal ingredients and traditional drugs used in health facilities according to quality standards applicable to selected herbal ingredients and traditional drugs. Separately store herbal ingredients and traditional drugs when finding that they fail to meet quality standards, and immediately trace to their origins.

7. Drug quality inspections agencies shall assume the responsibility to prevent and control counterfeit herbal ingredients and traditional drugs. To be specific:

a) Receive information and proposals given by relevant organizations and individuals, and publicly announce contact information (including telephone number, email and fax, etc.);

b) Disseminate adverse effects of counterfeit herbal ingredients and traditional drugs, signs for indentifying and measures for avoiding buying counterfeit herbal ingredients and traditional drugs, and ways to report regulatory authorities on suspected herbal ingredients and traditional drugs;

c) Publish on their websites and other appropriate means of mass media information concerning counterfeit herbal ingredients and traditional drugs discovered and handling results;

d) Directly carry out or cooperate with relevant agencies to carry out market surveillance so as to discover and handle counterfeit herbal ingredients and traditional drugs sold on the market in a timely manner;

dd) Cooperate and assist relevant authorities to investigate and trace back to the origins of counterfeit herbal ingredients and traditional drugs;

e) Take actions against the manufacture and trading in herbal ingredients and traditional drugs which are counterfeit, illegally imported or have unknown origins;

g) The Traditional Medicine Administration of Vietnam shall take charge of cooperating, communicating and exchanging information concerning counterfeit herbal ingredients and traditional drugs with relevant international organizations (such as WHO) and foreign pharmaceutical agencies.

8. Social security agencies shall:

a) Regularly update information concerning the origins of herbal ingredients published on the website of the Traditional Medicine Administration of Vietnam so as to manage the payment of costs covered by health insurance fund;

b) Suspend payment for covered services in case the origins of herbal ingredients/ traditional drugs are unidentified.

Article 24. Responsibility for implementation

The Director of Traditional Medicine Administration of Vietnam, Chief of the Ministry’s Office, the Ministry’s Chief Inspector, heads of departments and affiliates of the Ministry of Health, the Provincial Departments of Health, establishments trading in herbal ingredients and traditional drugs, and other relevant authorities, organizations and individuals shall implement this Circular.

Difficulties that arise during the implementation of this Circular should be promptly reported to the Traditional Medicine Administration of Vietnam affiliated to the Ministry of Health for consideration./.