Circular No. 32/2020/TT-BYT stipulates the standards for processing and compounding traditional medicine in healthcare facilities practicing traditional medicine.

CIRCULAR

Regulations on the standards for processing and compounding traditional medicine in healthcare facilities practicing traditional medicine

____________________

BASED ON THE PHARMACEUTICAL LAW dated April 6, 2016;

Pursuant to the Government's Decree No. 75/2017/NĐ-CP dated June 20, 2017 stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Traditional Medicine Management Department;

The Minister of Health issues this Circular to stipulate the standards for processing and compounding traditional medicine in healthcare facilities practicing traditional medicine as follows:

Article 1. Scope of Regulation

1. This Circular stipulates the standards and the declaration of compliance with the standards for processing and compounding traditional medicine in healthcare facilities practicing traditional medicine that have organizations for processing and compounding traditional medicine.

2. This Circular does not apply to the compounding of traditional medicine in the form of decoctions or boiled medicines for patients at healthcare facilities practicing traditional medicine. The method of boiling medicine shall be carried out in accordance with Decision No. 26/2008/QĐ-BYT dated July 22, 2008 of the Minister of Health on the issuance of traditional medical technical procedures.

Article 2. Interpretation of Terms

1. Processing of traditional herbal medicine according to traditional methods is the process of changing the quality and quantity of medicinal materials into traditional herbal medicine according to the theory and methods of traditional medicine or based on folk experience including preliminary processing, slicing, and complex processing.

2. Compounding traditional medicine is the process of combining or transforming medicinal materials and traditional herbal medicine into traditional medicine in traditional dosage forms and modern dosage forms.

a) Traditional dosage form is the finished product in the form of extract, hard pills, soft pills, powder medicine, tea medicine, medicinal alcohol, medicinal spirit.

b) Modern dosage form is the finished product in the form of tablets, soluble powder, soluble granules, drop pills, syrup, hard capsules, soft capsules, mist inhalation medicine, and other forms not mentioned above.

Article 3. Standards for processing and compounding traditional medicine

1. Healthcare facilities practicing traditional medicine that organize the processing of medicinal materials and traditional herbal medicine shall implement the standards prescribed in Appendix I attached to this Circular.

2. Healthcare facilities practicing traditional medicine that organize the compounding of traditional medicine in traditional dosage forms shall implement the standards prescribed in Appendix II attached to this Circular.

3. Healthcare facilities practicing traditional medicine that organize the compounding of traditional medicine in modern dosage forms shall implement the standards prescribed in Appendix III attached to this Circular.

4. In the case where a provincial or centrally-administered municipal Traditional Medicine Hospital has an organization for processing and compounding traditional medicine for sale to other healthcare facilities practicing traditional medicine within the same province or centrally-administered municipality, it must implement the provisions in Appendices VI and VII of Circular No. 35/2018/TT-BYT dated November 22, 2018 of the Minister of Health on Good Manufacturing Practices for Medicines and Active Pharmaceutical Ingredients and must be evaluated in accordance with the provisions of this Circular.

Article 4. Documents for declaring compliance with the standards for processing and compounding traditional medicine

1. A copy of the license for operation of the healthcare facility practicing traditional medicine;

2. A declaration of compliance with the conditions for processing and compounding traditional medicine as prescribed in Form No. 01 of Appendix IV attached to this Circular;

3. A report on compounding and processing activities of traditional medicine as prescribed in Form No. 02 of Appendix IV attached to this Circular.

Article 5. Procedure for Announcing Compliance with Standards for Processing and Preparing Traditional Medicine

1. Medical facilities providing traditional medicine services shall submit the announcement compliance with processing and preparing traditional medicine standards through the online public service system or via postal service or directly to the receiving agency (Ministry of Health or Department of Health) according to the following regulations:

a) The Ministry of Health (Traditional Medicine Management Agency) for medical facilities under the management of the Ministry of Health and health departments.

b) The Department of Health for medical facilities under the management of the Department of Health.

2. Within thirty days from the date recorded on the Application Form for Announcement Submission according to Model No. 3 attached as Appendix IV of this Circular, the receiving agency specified in Clause 1 of this Article shall be responsible for reviewing the application:

a) In case the application of the medical facility meets the requirements, the receiving agency shall announce on its electronic information website (website) according to Model No. 06 attached as Appendix IV of this Circular.

b) In case the application does not meet the requirements, the receiving agency must issue a written response to the facility and clearly state the reasons for requesting amendments and supplements.

Within sixty days from the date recorded on the document requesting amendments and supplements, the medical facility must complete the amendments and supplements and resubmit the application to the receiving agency.

Within seven working days from the date of receipt of the amended and supplemented application, the receiving agency shall evaluate the application and announce on its electronic information website if it meets the requirements. If the application does not meet the requirements, the agency will issue a written response stating the reasons and requesting amendments and supplements. After sixty days from the date recorded on the document requesting amendments and supplements, if the organization or individual does not make amendments and supplements, the application will lose its validity.

3. In case there is a change in the person in charge of the specialized field, the processing and preparing area; or the processing and preparing equipment, the medical facility must notify the receiving agency specified in Clause 1 of this Article in writing about the changes. The facility can process and prepare traditional medicine immediately after submitting the notification. The receiving agency will conduct post-inspection on these contents.

Article 6. Inspection and Evaluation of Compliance with Standards for Processing and Preparing Traditional Medicine

1. Every year in November, the receiving agency shall announce on its electronic information website the plan for inspecting and evaluating the maintenance of compliance with standards for processing and preparing traditional medicine and send this plan to the facilities listed in the plan.

2. At least thirty days before the inspection and evaluation date according to the plan announced by the receiving agency, the facility must submit a report on its processing and preparing activities of traditional medicine to the receiving agency according to Model No. 2 attached as Appendix IV of this Circular.

Example: If the scheduled periodic evaluation at Facility A is October 28, 2021, then Facility A must submit the report on its processing and preparing activities of traditional medicine to the receiving agency before September 28, 2021.

3. In case the facility fails to submit the report on its processing and preparing activities of traditional medicine within the time limit stipulated in Clause 2 of this Article, the receiving agency will conduct an unannounced inspection of the medical facility's processing and preparing activities of traditional medicine.

4. The inspection and evaluation record shall be documented in writing according to Model No. 4 attached as Appendix IV of this Circular.

5. Handling of Inspection and Evaluation Results:

a) In case the inspection and evaluation results conclude that the medical facility complies with the standard at Level 1 as prescribed in Appendix V of this Circular, the facility may continue processing and preparing.

b) In case the inspection and evaluation results conclude that the medical facility complies with the standard at Level 2 but has serious issues as prescribed in Appendix V of this Circular, the receiving agency shall issue a written notice requesting rectification and correction of the issues to the inspected facility.

- Within forty-five days from the date the receiving agency issues the notice requesting rectification and correction of serious issues, the inspected facility must complete the rectification and correction and submit a written report accompanied by evidence (documents, images, videos, certificates, and other materials) proving completion of the rectification and correction mentioned in the notice.

- Within ten days from the date of receipt of the facility's report and supporting evidence (documents, images, videos, certificates, and other materials), the receiving agency shall assess the rectification results and conclude on the compliance status of the facility's processing and preparing activities.

+ In case the rectification meets the requirements: The receiving agency shall issue a notice agreeing with the rectification and correction content.

+ In case the rectification and correction do not meet the requirements: The receiving agency shall withdraw the previously published announcement on its electronic information website and handle the situation according to the Government Decree No. 117/2020/NĐ-CP dated September 28, 2020 on administrative violations in the healthcare sector.

c) In case the inspection and evaluation results conclude that the medical facility complies with the standard at Level 3 but has severe issues as prescribed in Appendix V of this Circular, the receiving agency shall withdraw the previously published announcement on its electronic information website and handle the situation according to the Government Decree No. 117/2020/NĐ-CP dated September 28, 2020 on administrative violations in the healthcare sector.

Article 7. Implementation Organization

1. The Traditional Medicine Management Department shall be responsible for:

a) Guidance, organization, implementation, inspection, and evaluation of the implementation of this Circular nationwide.

b) Inspect and evaluate traditional medicine healthcare facilities directly under the central level and Ministries.

c) Direct provincial health departments and centrally-administered city health departments to implement this Circular.

d) Publicize and regularly update on the Traditional Medicine Management Department's electronic information website a list of facilities that meet the criteria for processing and compounding traditional medicines at traditional medicine healthcare facilities as prescribed in this Circular.

2. Provincial health departments and health agencies of Ministries and Departments shall be responsible for:

a) Directing and organizing the implementation of this Circular within their respective jurisdictions and managed units.

b) Inspecting and evaluating the results of implementing this Circular within their respective jurisdictions and managed units.

c) Publicizing and regularly updating on the provincial health department's electronic information website a list of traditional medicine healthcare facilities that meet the criteria for processing and compounding traditional medicines according to Model No. 5 of Appendix IV issued together with this Circular.

d) Reporting according to Model No. 6 of Appendix IV issued together with this Circular to the Ministry of Health (Traditional Medicine Management Department) before December 31 each year to update the Ministry of Health's (Traditional Medicine Management Department) information system with information about traditional medicine healthcare facilities that meet the criteria for processing and compounding traditional medicines.

3. Traditional medicine healthcare facilities shall be responsible for:

a) Implementing the provisions of this Circular.

b) Conducting self-assessment of the processing and compounding standards for medicines processed and compounded by the facility as prescribed in this Circular and bearing responsibility for the information published.

c) Reporting according to Model No. 02 of Appendix IV issued together with this Circular to the receiving agency specified in Clause 1, Article 5 of this Circular upon receipt of inspection plans and reporting periodically before December 31 each year.

Article 8. Transitional Provisions

For medicines compounded by traditional medicine healthcare facilities that fall within the scope of payment by the Health Insurance Fund as stipulated in Circular No. 05/2015/TT-BYT dated March 17, 2015, issued by the Minister of Health on the List of Traditional Chinese Medicine, Medicines from Herbal Materials, and Traditional Medicine Ingredients within the Scope of Payment by the Health Insurance Fund, and Circular No. 50/2017/TT-BYT dated December 29, 2017, issued by the Minister of Health amending and supplementing relevant regulations related to payment for medical examination and treatment costs, if such medicines were compounded before December 31, 2022 for traditional medicine ingredients and before December 31, 2023 for traditional medicines, they will continue to be reimbursed by the Health Insurance Fund until the expiration date of the medicines.

Article 9. Cross-References

In cases where referenced documents in this Circular are replaced or amended, the replacement or amended documents shall apply.

Article 10. Implementation Timeline

1. Traditional medicine healthcare facilities that organize the processing of traditional medicine ingredients must announce compliance with the processing standards for traditional medicine ingredients as prescribed in this Circular before December 31, 2022.

2. Traditional medicine healthcare facilities that organize the compounding of traditional medicines must announce compliance with the compounding standards for traditional medicines as prescribed in this Circular before December 31, 2023.

3. Encourage traditional medicine healthcare facilities to apply this Circular prior to the mandatory application date as stipulated in Clauses 1 and 2 of this Article.

Article 11. Effective Date

This Circular takes effect from February 17, 2021.

During the process of implementation, if there are difficulties or obstacles, please promptly reflect them to the Ministry of Health (Traditional Medicine Management Department) for consideration and guidance./.