Circular No. 30/2017/TT-BYT guides the processing methods for traditional herbal medicines

CIRCULAR

GUIDANCE ON THE METHODS OF PREPARING TRADITIONAL MEDICINE FORMULAE

Pursuant to the Drug Law No. 105/2016/QH13 dated April 6, 2016;

Pursuant to Decree No. 75/2017/NĐ-CP dated June 20, 2017 of the Government 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 guide the methods of preparing traditional medicine formulae.

Article 1. Scope of Regulation and Applicability

1. This Circular guides the general methods for preparing traditional medicine formulae and the specific methods for preparing certain traditional medicine formulae.

2. This Circular applies to medical examination and treatment facilities, herbal medicine trading establishments, traditional medicine trading establishments, and medicinal herb trading establishments that engage in the preparation of traditional medicine formulae (hereinafter referred to as "facilities") and related organizations and individuals.

Article 2. Interpretation of Terms

In this Circular, the following terms shall be understood as follows:

1. Traditional method of preparing traditional medicine formulae is the process of changing the quality and quantity of medicinal herbs into prepared traditional medicines according to the theories and methods of traditional medicine or folk experience (commonly referred to as the principles of traditional medicine).

2. Preliminary processing includes soaking, fermenting, washing, drying, and slicing.

3. Slicing is the process of dividing medicinal herbs into appropriate sizes.

4. Complex processing is the complex processing according to the principles of traditional medicine, using fire, water, or a combination of water and fire, or other auxiliary materials depending on the requirements of each medicinal herb to meet the specific requirements of each traditional medicine in treatment.

5. Auxiliary materials used in preparing traditional medicine formulae are raw materials used at various stages of the processing to enhance therapeutic effects, limit unwanted side effects, and unpleasant tastes of the medicine.

Article 3. Issuance of Methods for Preparing Traditional Medicine Formulae

1. The general methods for preparing traditional medicine formulae are specified in Appendix I attached to this Circular.

2. The methods for preparing 103 traditional medicine formulae are specified in Appendix II attached to this Circular.

Article 4. Guidance on Implementation

1. The general methods for preparing traditional medicine formulae and the specific methods for preparing 103 traditional medicine formulae specified in Appendices I and II attached to this Circular shall be used by facilities to establish their processing and production procedures for traditional medicine formulae.

2. In cases where facilities use different preparation methods for traditional medicine formulae currently circulating in Vietnam but not specified in Appendix II attached to this Circular, they must apply the preparation methods printed in officially published textbooks for training pharmacists and physicians specializing in traditional medicine by the Medical Publishing House.

Article 5. Effective Date

1. This Circular takes effect from August 28, 2017.

2. This Circular replaces and terminates the effectiveness of the following documents: Decision No. 39/2008/QĐ-BYT dated December 15, 2008 of the Minister of Health on issuing General Methods for Preparing Traditional Medicine Formulae According to Traditional Methods; Decision No. 3759/QĐ-BYT dated October 8, 2010 of the Minister of Health on issuing Quality Assurance Methods for Preparing 85 Traditional Chinese Medicines; and Decision No. 3635/QĐ-BYT dated September 16, 2014 of the Minister of Health on issuing Quality Assurance Methods for Preparing 18 Traditional Chinese Medicines.

Article 6. Implementation Organization

1. The Department of Traditional Medicine Management is responsible for directing and coordinating with Provincial Health Departments to implement, supervise the implementation of this Circular, and inspect the processing procedures and equipment of facilities engaged in preparing traditional medicine formulae nationwide.

2. Facilities must establish processing procedures for traditional medicine formulae and use appropriate equipment for their processing activities in accordance with this Circular.

3. The Director of the Ministry's Office, the Inspectorate Chief, the Director of the Department of Traditional Medicine Management under the Ministry of Health, the Directors of Provincial Health Departments, and the Heads of relevant units are responsible for implementing this Circular. Any issues encountered during implementation should be promptly reported to the Department of Traditional Medicine Management, Ministry of Health for consideration and resolution.

Any issues encountered during implementation should be promptly reported to the Department of Traditional Medicine Management, Ministry of Health for consideration and resolution./.