Circular No. 47/2018/TT-BYT stipulates the application of conditions regarding diplomas, certificates, and practical experience for issuing traditional medicine practice certificates.

CIRCULAR

Regulations on the application of qualifications, certificates, and certificates of practice for issuing traditional medicine practitioner licenses

The Minister of Health issues this Circular to regulate the application of conditions regarding qualifications, certificates, and certificates of practice related to traditional medicine for issuing traditional medicine practitioner licenses.

traditional herbal pharmacy practice certificate

Pursuant to the Drug Law No. 105/2016/QH13 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,

Article 1. Scope of Regulation and Application

1. This Circular stipulates the application of conditions regarding qualifications, certificates, and certificates of practice related to traditional medicine issued before the effective date of the Medicine Law No. 105/2016/QH13 (before January 1, 2017), in accordance with economic and social development needs and the demand for medical examination and treatment at each locality during different periods, the content and basis of specialized practice for obtaining a traditional medicine practitioner license.

2. Individuals holding qualifications, certificates, and certificates regulated by this Circular who have already been granted a practice license according to the Medical Examination and Treatment Law shall not be subject to the provisions of this Circular.

2. Individuals who hold certificates, diplomas, or certificates as prescribed in this Circular and have already been issued a practice certificate in accordance with the Law on Medical Examination and Treatment shall not be subject to the provisions of this Circular.

Article 2. Types of Qualifications, Certificates, and Certificates Related to Traditional Medicine

1. Certificate of being a traditional physician issued by the Ministry of Health or the Department of Health.

2. Certificate of being a traditional pharmacist issued by the Ministry of Health or the Department of Health.

3. Certificate of having sufficient professional qualifications in traditional pharmacy issued by the Department of Health prior to the effective date of Circular No. 13/1999/TT-BYT dated July 6, 1999, of the Ministry of Health guiding the implementation of the Private Practice of Medicine and Pharmacy Act (hereinafter referred to as Circular No. 13/1999/TT-BYT).

4. Certificate of meeting the conditions for practicing traditional pharmacy issued by the Department of Health from July 21, 1999, to January 21, 2004.

5. Certificate or certificate of traditional medicine issued by an institution authorized to train before the effective date of the Medicine Law No. 105/2016/QH13 and has been granted a traditional pharmacy practice permit by the Department of Health according to Circular No. 02/2007/TT-BYT dated January 24, 2007, of the Minister of Health detailing the implementation of certain provisions of the Medicine Law and Decree No. 79/2006/NĐ-CP dated August 9, 2006, of the Government detailing the implementation of certain provisions of the Medicine Law.

Article 3. Practice Organizations

Article 3. Practice Organizations

1. Practice Requirements

a) Individuals holding a certificate of being a traditional physician must undergo practice before obtaining a traditional medicine practitioner license as stipulated in Clause 2 and Clause 3 of this Article;

b) Individuals holding certificates specified in Clauses 2, 3, 4, and 5 of Article 2 of this Circular who have been granted a traditional pharmacy practice permit by the Department of Health do not need to undergo practice when applying for a traditional medicine practitioner license.

2. Duration of Practice for Individuals Holding a Certificate of Being a Traditional Physician:

a) The duration of practice for individuals responsible for pharmaceutical matters in wholesale and retail traditional medicine establishments is one year;

b) The duration of practice for individuals responsible for pharmaceutical matters in wholesale and retail herbal medicine establishments is six months;

c) The duration of practice for individuals responsible for pharmaceutical matters or quality assurance in households or cooperatives producing herbal medicines is one year.

3. Content and Basis of Practice for Individuals Holding a Certificate of Being a Traditional Physician:

a) Individuals responsible for pharmaceutical matters in wholesale herbal medicine and traditional medicine establishments and individuals responsible for pharmaceutical matters or quality assurance in households or cooperatives producing herbal medicines must follow the regulations set forth in Articles 19 and 20 of Decree No. 54/2017/NĐ-CP dated May 8, 2017, of the Government detailing certain provisions and measures to implement the Medicine Law;

Article 4. Principles for applying qualifications, certificates, and certification related to traditional medicine in accordance with economic and social conditions and the healthcare needs of the people in each locality during each period.

1. Persons holding a certificate as a Traditional Medicine Practitioner as stipulated in Clause 1, Article 2 of this Circular are permitted to register to operate traditional medicine businesses nationwide.

2. Based on the economic and social conditions of each locality and the healthcare needs of the people in each locality during each period, the Director of the Provincial Department of Health shall decide to issue a practice certificate for traditional medicine to persons holding certificates or certificates as stipulated in Clauses 2, 3, 4, and 5 of Article 2 of this Circular, and such persons may only practice in that locality.

Article 5. Scope of Practice for Traditional Medicine with respect to persons holding certificates or certificates regarding Traditional Medicine.

1. Persons holding a certificate as a Traditional Medicine Practitioner as stipulated in Clause 1, Article 2 of this Circular are responsible for the professional aspects of traditional medicine at wholesale and retail establishments dealing in medicinal herbs and traditional medicines, and are responsible for the professional aspects of traditional medicine or for ensuring quality at households, cooperatives engaged in the production of medicinal herbs.

2. Persons holding a certificate as a Traditional Medicine Pharmacist as stipulated in Clause 2, Article 2 of this Circular are responsible for the professional aspects of traditional medicine at wholesale and retail establishments dealing in medicinal herbs and traditional medicinal ingredients.

3. Persons holding other certificates or certificates regarding Traditional Medicine as stipulated in Clauses 3, 4, and 5, Article 2 of this Circular are responsible for the professional aspects of traditional medicine at wholesale and retail establishments within the scope of practice already granted by the Department of Health.

Article 6. Effectiveness

1. This Circular takes effect from March 1, 2019.

2. The Circular number 02/2007/TT-BYT dated January 24, 2007 of the Minister of Health guiding detailed implementation of certain provisions on drug business conditions under the Drug Law and Decree number 79/2006/NĐ-CP dated August 9, 2006 of the Government detailing implementation of certain provisions of the Drug Law shall be abolished from the date this Circular takes effect.

Article 7. Reference Provisions

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

Article 8. Responsibility for Implementation

Gentlemen, Ladies: Heads of the Ministry's Office, Directors of the Traditional Medicine and Pharmaceutical Management Bureau; Director of the Pharmaceutical Management Bureau; Head of the Ministry's Inspectorate; Directors of all Bureaus; Heads of all Departments under the Ministry of Health; Directors of Provincial Departments of Health directly under the Central Government are responsible for organizing the implementation of this Circular. In the course of implementation, if there are difficulties or obstacles, please promptly report them to the Ministry of Health (Traditional Medicine and Pharmaceutical Management Bureau) for consideration and resolution.

During the implementation process, if difficulties or obstacles arise, relevant agencies, organizations, and individuals are requested to promptly report to the Ministry of Health (Traditional Medicine Management Department) for consideration and resolution.