Circular No. 09/2002/TT-BYT guiding the implementation of Decision No. 71/2002/QĐ-TTg dated June 7, 2002 of the Government Chairman on the management of medicines for human treatment through non-trade export and import.

CIRCULAR

Guidelines for Implementing Decision No. 71/2002/QĐ-TTg

dated June 7, 2002, of the Government Prime Minister on the management of medicines for human treatment through non-commercial export and import

Pursuant to the Law on Prevention and Control of Narcotics dated December 22, 2000;

Pursuant to the Law on Health Care for the People dated July 11, 1989;

Pursuant to Decision No. 71/2002/QĐ-TTg dated June 7, 2002, of the Government Prime Minister on the management of medicines for human treatment through non-commercial export and import, the Ministry of Health guides the management of medicines for human treatment through non-commercial export and import as follows:

I. General Provisions:

1. This Circular regulates activities related to the export and import of medicines and raw materials for medicines through non-commercial channels. For medicines exported through non-commercial channels, in addition to complying with the provisions of this Circular, they must also comply with the regulations of the importing country.

2. Medicines for human treatment brought into Vietnam by overseas Vietnamese residents, Vietnamese citizens working abroad, experts, officials, students, tourists, or sent from abroad legally entering Vietnam, or sent out of Vietnam or taken out of Vietnam by individuals are referred to as non-commercial imported or exported medicines.

3. Non-commercially exported and imported medicines are only for personal and family treatment purposes and may not be sold on the market or used for any other purpose.

4. Non-commercially exported and imported medicines must have labels clearly indicating the name of the medicine, active ingredient, concentration, and quantity.

II. List of Medicines and Raw Materials for Medicines Prohibited from Export and Import Through Non-Commercial Channels:

1. Raw materials and auxiliary materials for medicines.

2. Medicines listed in the Catalogue of Medicines for Human Treatment Prohibited from Non-Commercial Export and Import attached hereto.

III. Specific Regulations on Quantity and List of Medicines Permitted for Export and Import Through Non-Commercial Channels:

1. Addictive Medicines:

1.1. Addictive medicines as specified in the Catalogue of Addictive Medicines issued together with the Regulation on Management of Addictive Medicines promulgated by the Minister of Health are permitted for non-commercial export and import.

1.2 Addictive medicines exported and imported through non-commercial channels can only be carried by individuals upon entry or exit if accompanied by a prescription from a specialist physician prescribing such medicines.

1.3 Upon entry or exit, individuals carrying these medicines must declare fully and accurately the name of the medicine and the quantity of each medicine and present the prescription for the customs authorities to examine and process.

1.4 The quantity of addictive medicines carried by individuals upon entry or exit shall not exceed the amount prescribed for seven days and the value of each transaction shall not exceed 30 USD, with each type of medicine not exceeding 10 USD. In cases where the value exceeds the prescribed limit, approval from the Ministry of Health (Vietnam Drug Administration) is required.

2. Other Finished Medicines:

Other finished medicines, the value of each transaction for non-commercial export and import shall not exceed 30 USD, with each type of medicine not exceeding 10 USD. The maximum number of times an individual can receive and send medicines in a year is three. For specialized mental health medicines and medicines containing precursors used as medicines, prescriptions from specialist physicians of the exporting country for individuals entering Vietnam and from Vietnamese specialist physicians for individuals receiving and sending medicines are required.

In cases where the value of specialized therapeutic medicines exceeds the prescribed limit or the number of times medicines are received for necessary treatment exceeds the prescribed limit, opinions from the local Department of Health at the port of export and import of non-commercial medicines must be obtained based on compliance with medical technical regulations and pharmaceutical regulations.

IV. Implementation Regulations and Handling of Violations:

1. Medicines for human treatment exported and imported through non-commercial channels contrary to the provisions of this Circular will be treated as illegally exported and imported medicines and subject to confiscation and destruction.

2. Units and individuals transporting and trading in medicines exported and imported through non-commercial channels contrary to the provisions of this Circular will be considered as illegally transporting and trading in medicines and will be subject to legal penalties according to the degree of violation.

This Circular takes effect from the date of issuance and replaces Circular No. 14/BYT-TT dated August 1, 1994, of the Minister of Health. Any difficulties encountered during implementation should be reported to the Ministry of Health (Vietnam Drug Administration) for study and resolution.

V. Implementation Provisions

This Circular takes effect from the date of issuance and replaces Circular No. 14/BYT-TT dated August 1, 1994, issued by the Minister of Health. Any difficulties encountered during implementation should be reported to the Ministry of Health (Vietnam National Pharmaceutical Administration) for study and resolution.