Chương VII Thông tư 38/2021/TT-BYT: Điều khoản thi hành

Chapter VII

IMPLEMENTATION CLAUSES

Article 23. Effect

1. This Circular comes into force from February 15, 2022.

2. Circular No. 13/2018/TT-BYT dated May 15, 2018 of the Ministry of Health of Vietnam on quality of herbal materials and traditional medicines is no longer valid from the date on which this Circular takes effect.

Article 24. Terms of reference

If legislative documents referred to herein are superseded or amended, the new ones shall be applied.

Article 25. Transitional provisions

Before May 15, 2022, establishments trading in herbal materials must publish the quality standards as prescribed in this Circular.

Article 26. Responsibilities for organizing implementation

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:

Annually formulating the plan for sampling of herbal materials, prepared traditional medicinal materials and traditional medicines 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 materials, prepared traditional medicinal materials and traditional medicines for testing their quality;

c) Provide the National Institute of Drug Quality Control and the Institute of Drug Quality Control of Ho Chi Minh city with samples of labels and standards for quality of herbal materials, prepared traditional medicinal materials and traditional medicines published or granted certificate of free sale;

d) Conduct inspection of quality of herbal materials, prepared traditional medicinal materials and traditional medicines imported, farmed, harvested, manufactured, prepared and sold nationwide; instruct and supervise testing facilities taking charge of testing herbal materials, prepared traditional medicinal materials and traditional medicines nationwide; reach conclusions about quality of  herbal materials, prepared traditional medicinal materials and traditional medicines based on testing reports given by state-owned testing facilities and relevant documents;

dd) Take charge or cooperate in performing state inspection and handling violations against regulations on quality of herbal materials,  prepared traditional medicinal materials and traditional medicines intra vires;

e) Update its website with the list of establishments making commitments to sites where herbal materials are cultivated and harvested within 30 days after receiving the commitments to sites where herbal materials are cultivated and harvested of such establishments;

g) Consolidate quantity of types and volumes of herbal materials imported annually;

h) Consolidate reports on use of herbal materials, prepared traditional materials and traditional medicines nationwide by December 31 of every year;

i) Formulate systems of tracing origins of herbal materials, prepared traditional medicinal materials and traditional medicines.

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

a) Organize implementation of quality control of herbal materials, prepared traditional medicinal materials and traditional medicines in the province and handle violation as prescribed by law;

b) Direct the qualified testing center of province to develop plans on taking samples of herbal materials, prepared traditional medicinal materials and traditional medicines for annual quality inspection and  cost estimates and send them to the Department of Health for consideration and allocation of budgets;

c) Update information about samples of herbal materials, prepared traditional medicinal materials and traditional medicines taken (including names of herbal materials, prepared traditional medicinal materials and traditional medicines; origins; active elements; dosage forms; quality standards; numbers of sales registration forms; numbers of licenses for import; numbers of batches; expiry dates; names, addresses of importers, manufacturers and establishments taking samples);  

d) Organize collection of information and update lists of establishments and locations of farming and cultivating herbal materials in the province on the website of the Provincial Department of Health.

3. Responsibilities of medicine testing facilities:

a) Central testing facilities (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 materials, prepared traditional medicinal materials and traditional medicines imported; farmed, cultivated; manufactured, processed; sold and used. Send testing reports to the Ministry of Health (via TMA) and the Department of Health of province where samples are taken;

- Do research, establish and publish on their websites and the website the list of reference standards, reference substances and impurity reference substances used for analysis and testing of samples of herbal materials, prepared traditional medicinal materials and traditional medicines imported; farmed and cultivated; manufactured and processed; sold and used in the territory of Vietnam;

- Provide qualified testing centers of provinces and central-affiliated cities as assigned with the copies or electronic files of quality standards of herbal materials, prepared traditional medicinal materials and traditional medicines.

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

- Carry out analysis and testing of samples so as to determine the quality of herbal materials, prepared traditional medicinal materials and traditional medicines imported; farmed, cultivated; manufactured, processed; sold and used.

- Notify the Ministry of Health (via TMA) and the National Institute of Drug Quality Control of the list of qualified testing criteria and issuance of Certificates as prescribed.

- Report the testing results of samples of herbal materials, prepared traditional medicinal materials and traditional medicines to the Departments of Health of the province where the samples are taken and the Ministry of Health (via TMA).

4. Establishments trading in herbal materials, prepared traditional medicinal materials and traditional medicines shall:

a) Comply with regulations on quality control of herbal materials, prepared traditional medicinal materials and traditional medicines herein;

b) Ensure quality of their herbal materials, prepared traditional medicinal materials and traditional medicines during their operation (farming, cultivating; exporting, importing; processing, manufacturing; preserving; transporting; distributing) and manage quality thereof according to the licensed scope of business and in compliance with law regulations;

c) Periodically report the situation of farming and cultivating herbal materials; situation of domestically trading in herbal materials, prepared traditional medicinal materials according to Form 11 of Appendix I issued together with this Circular;

d) Participate in the origin tracing system for updating written proofs of origins of herbal materials, prepared traditional medicinal materials and traditional medicines;

dd) Immediately trace origins and notify state regulatory authorities and other traders when discovering counterfeit or substandard herbal materials, prepared traditional medicinal materials and traditional medicines;

e) Store documents and information related to the import, sales, export and distribution of herbal materials, prepared traditional medicinal materials and traditional medicines in a manner that origins thereof are able to be traced, and quality thereof during the period of farming, cultivating; exporting, importing; processing, manufacturing; preserving; transporting; distributing is able to inspect and control;

g) Pay for testing and providing reference standards and reference substances for testing facilities in case the testing facilities do not have any reference standard or reference substance or do not find out reference standards and reference substances for the samples of herbal materials, prepared traditional medicinal materials and traditional medicines whose testing results are sent by trading establishments;

h) Comply with regulations of law on pharmacy to maintain quality of herbal materials, prepared traditional medicinal materials and traditional medicines during their business, sales and use.

5. Health facilities shall:

a) Use and apply herbal materials, prepared traditional medicinal materials and traditional medicines that have clear origins as prescribed in Article 13 herein and are supplied by trading establishments granted certificate of eligibility for pharmaceutical trading;

b) Periodically or ad hoc inspect quality of herbal materials, prepared traditional medicinal materials and traditional medicines that they use. Separately store and trace origins to carry out the next steps as per regulation when discovering counterfeit or substandard herbal materials, prepared traditional medicinal materials and traditional medicines. Herbal materials, prepared traditional medicinal materials and traditional medicines used in these facilities must be inspected via Board of import inspection of hospitals as prescribed in Circular No. 22/2011/TT-BYT dated June 10, 2011 of the Ministry of Health on organization and operation of the Faculty of Pharmacy of hospitals or the registration department of other health facilities;

c) With regard to traditional medicines produced by health facilities as prescribed in Article 70 of the Law on Pharmacy and prepared traditional medicinal materials processed by other health facilities as prescribed in Clause 2, Article 70 of the Law on Pharmacy, health facilities must carry out the quality control at state testing facilities achieving GLP or testing service providers that have been granted certificates of eligibility for pharmaceutical business. In case health facilities have laboratories achieving GLP certificate, the quality testing of herbal materials, prepared traditional medicinal materials and traditional medicines shall be done at laboratories of such health facilities;

d) In case prepared traditional medicinal materials are processed at a health facility and only used at such facility, the facility must inspect the quality processing, manufacture and control process;

dd) Heads of health facilities shall be responsible for organizing periodic inspection for at least once every 03 month or ad hoc inspection if necessary of the process for processing, manufacturing and controlling herbal materials, prepared traditional medicinal materials and traditional medicines at such health facilities. Results of the inspection must be recorded in writing and stored as prescribed;

e) If there is a risk affecting the quality of herbal materials, prepared traditional medicinal materials and traditional medicines, health facilities must send a sample to state testing facilities achieving GLP certificate or testing service providers which have been granted certificates of eligibility for pharmaceutical business.

6. Responsibilities of management agencies in control and prevention of unknown, counterfeit and substandard herbal materials, prepared traditional medicinal materials and traditional medicines:

a)  Receive feedbacks from organizations and individuals;

b) Disseminate signs to prevent unknown, counterfeit and substandard herbal materials, prepared traditional medicinal materials and traditional medicines for pharmaceutical trading establishments; methods for notifying state management agencies of suspicious cases of unknown, counterfeit and substandard herbal materials, prepared traditional medicinal materials and traditional medicines;

c) Inform publicly on websites or e-portals of such agencies and mass media about cases of unknown, counterfeit and substandard herbal materials, prepared traditional medicinal materials and traditional medicines detected on the market and results of handling such cases;

d) Carry out or cooperate with relative functional agencies in inspecting, monitoring and promptly detecting unknown, counterfeit and substandard herbal materials, prepared traditional medicinal materials and traditional medicines sold on the market;

dd) Offer cooperation with and support to functional agencies in tracing origins of counterfeit and substandard herbal materials, prepared traditional medicinal materials and traditional medicines;

e) Handle as prescribed violation cases of trading in unknown and unapproved herbal materials, prepared traditional medicinal materials and traditional medicines;

g) TMA is the focal agency to cooperate, contact and exchange information about unknown, counterfeit and substandard herbal materials, prepared traditional medicinal materials and traditional medicines with relative international organizations and pharmaceutical management agencies of other countries.

Article 27. Responsibility for implementation

Chief of the Ministry Office, Chief Inspector of the Ministry, Director General of TMA, heads of units affiliated to the Ministry of Health, Departments of Health of provinces and central-affiliated cities, pharmaceutical trading establishments, relevant agencies, organizations and individuals are responsible for the implementation of this Circular.

Agencies, organizations and individuals should report difficulties that arise during the period of implementation of this Circular to the TMA of the Ministry of Health for consideration and settlement./.

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