Decision No. 577/BYT-QĐ Issuing the Interim Regulation on Importing Traditional Medicine Drugs

Pursuant to …;

Issuing the "Provisional Regulation on Importing Traditional Medicine Drugs"

THE MINISTER OF HEALTH

At the proposal of the Director of the Department of Ethnic Medicine and the Director of the Drug Management Department.

Pursuant to …;

Article 1: Now hereby issuing with this decision the "Provisional Regulation on Importing Traditional Medicine Drugs".

Article 2: This Decision takes effect from the date of issuance.

Article 3: The Heads of the Office, Directors of the Drug Management Department, Directors of the Department of Ethnic Medicine, Heads of Departments, units under direct management, and Directors of Health Services of provinces and centrally governed cities shall be responsible for implementing this Decision.

INTERIM REGULATION

ON IMPORTING TRADITIONAL MEDICINE DRUGS
(Issued together with Decision No. 577 dated July 8, 1993)

PART I
GENERAL PROVISIONS

Article 1: Traditional medicine drugs (YHCT) referred to in this regulation are understood as follows:

Traditional medicine preparations are forms of traditional medicine drugs produced from medicinal materials processed according to the theory and methods of preparation of traditional medicine used for disease prevention, treatment, and health maintenance.

Raw drugs (living drugs) used in traditional medicine are herbs, some animal products, and natural metal compounds used to prepare cooked drugs (processed drugs) and traditional medicine preparations for medical diagnosis, prescription, and drug dispensing by doctors.

Article 2: All traditional medicine preparations imported into Vietnam must be registered and granted registration numbers and import permits by the Ministry of Health according to the provisions of Circular No. 25/BYT-TT dated December 19, 1990, guiding the implementation of the regulation on registering foreign drugs imported into the Socialist Republic of Vietnam issued pursuant to Decision No. 249/BYT-QĐ dated May 15, 1989, and Circular No. 07/BYT-TT dated March 30, 1991 of the Ministry of Health on "Guidelines for Registration by Foreign Companies Permitted to Import Drugs - Raw Materials for Drugs with Organizations and Companies of the Socialist Republic of Vietnam."

Raw drugs imported into Vietnam must meet the specifications and quality standards stipulated in the Vietnamese Pharmacopoeia or those of the country from which the raw drugs are imported.

Article 3: Domestic production or trading establishments that have been granted import permits for drugs (according to Joint Circular No. 09/TT-LB dated July 17, 1992 of the Ministry of Health, Ministry of Trade, and Ministry of Tourism) may import traditional medicine drugs.

PART II
PROCEDURES FOR APPLYING FOR PERMITS TO IMPORT TRADITIONAL MEDICINE DRUGS

Article 4: Traditional medicine preparations wishing to be imported into Vietnam must satisfy the following conditions:

1. Possess a production and circulation permit from the Ministry of Health or an authorized agency of the relevant health authority of the exporting country.

2. Not currently circulating in Vietnam.

3. Ensure quality and safety for users.

4. Be consistent with Vietnam's policies on the development of traditional medicine and pharmaceuticals.

Article 5: Organizations, companies within and outside Vietnam, and individuals wishing to apply for registration numbers for importing traditional medicine drugs should submit their applications to the Ministry of Health (Drug Management Department). The application package includes:

1. Application form for registration.

2. Technical dossier of the drug for which a registration number is requested.

Finished product formula of the preparation

Toxicity test dossier of the preparation (LD50)

Technical standards, testing, and inspection methods for the preparation.

Origin dossier of the preparation.

3. For traditional medicine preparations originating from ancient prescriptions or modified ancient prescriptions, it is not necessary to provide experimental pharmacological test dossiers and clinical trial dossiers. For new traditional medicine preparations (New Formulas), additional experimental pharmacological test dossiers and clinical trial dossiers must be provided in accordance with the regulations on registering foreign drugs imported into the Socialist Republic of Vietnam issued together with Decision No. 249/BYT-QĐ dated May 15, 1989 of the Ministry of Health.

Article 6: Traditional medicine products imported through non-tariff channels must also meet all conditions stipulated in Article 4 of this regulation. The quantity of gifts received must comply with the prescribed regulations.

Article 7: The Drug Review Board of the Ministry of Health shall be tasked with advising the Ministry of Health on the following matters:

Reviewing applications for registration and technical documentation.

Organizing testing and inspection for products suspected of quality issues.

Issuing registration numbers, revoking issued registration numbers.

Article 8: Units or individuals applying to import and circulate traditional medicine drugs must bear the responsibility for paying administrative fees and licensing fees as prescribed in Circular No. 25/ BYT-TT dated December 19, 1990 on "Guidelines for Implementing the Regulation on Registration of Foreign Drugs Imported into the Socialist Republic of Vietnam," issued together with Decision No. 249/BYT-QD dated May 15, 1989 of the Ministry of Health.

CHAPTER III:
AUTHORITY TO ISSUE IMPORT LICENSES
TRADITIONAL MEDICINE DRUGS

Article 9: The Ministry of Health entrusts the Department of Pharmaceutical Management to coordinate with the Department of Ethnic Medicine to organize the review process to submit to the leadership of the Ministry for signing and issuing registration numbers and permits for importing traditional medicine drugs.

The Ministry of Health will issue formal or temporary registration numbers for each type of traditional medicine product applying for importation into Vietnam, simultaneously withdrawing registration numbers and import permits when there are violations of the regulations.

One year from the date of issuance of the registration number, if the drug has not been brought into Vietnam, the issued registration number will be deemed to have automatically expired.

PART IV
IMPLEMENTING PROVISIONS

Article 10: This regulation applies to all entities applying to import drugs into Vietnam.

Article 11: Organizations or individuals violating this regulation will be subject to legal action according to the degree of violation as prescribed by law./.