Circular No. 01/2007/TT-BYT guiding the management of medicines for human treatment through non-trade export and import.

CIRCULAR

Guidelines for managing medicines for human use through export and import channels outside of trade.

for persons through non-trade export and import routes.

                                                                          _________________________

Pursuant to the Law on Prevention and Control of Narcotics No. 23/2000/QH10 dated December 9, 2000;

Pursuant to the Medicine Law No. 34/2005/QH11 dated June 14, 2005;

Pursuant to the Government Decree No. 49/2003/NĐ-CP dated May 15, 2003 stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to the Government Decree No. 58/2003/NĐ-CP dated May 29, 2003 stipulating the control of import, export, and transit of narcotics, precursor substances, addictive drugs, and psychotropic substances through Vietnam;

Pursuant to the Prime Minister's Decision No. 71/2002/QĐ-TTg dated June 7, 2002 on the management of medicines for human use through export and import channels outside of trade;

The Ministry of Health hereby provides guidelines for managing medicines for human use through export and import channels outside of trade as follows:

This technical regulation sets out technical requirements, testing methods, sampling procedures; management requirements; responsibilities of organizations and individuals producing, trading, and importing cigarettes.

Article 1. This Circular regulates activities related to the export and import of medicines for human use (hereinafter referred to as medicines) through non-trade channels.

Article 2. Medicines imported from abroad by Vietnamese citizens residing overseas, Vietnamese citizens traveling abroad for work, study, tourism, or legally entering Vietnam, or sent back to Vietnam for personal and family use are called non-trade imported medicines. Medicines sent out of Vietnam or carried out of Vietnam by individuals for personal and family use are called non-trade exported medicines.

Article 3. Non-trade exported and imported medicines are solely for treating oneself and one’s family and may not be sold on the market or used for any other illegal purposes.

Article 4. Non-trade exported and imported medicines must bear labels clearly stating the name of the medicine, active ingredient, concentration, quantity, and expiration date.

Article 5. Prescriptions issued by Vietnamese doctors must comply with the format prescribed in the Prescription and Dispensing Regulations (Annex I).

Article 6. Prescriptions issued by foreign doctors must minimally include the following information:

a) Name and age of the patient;

b) Name of the medicine, dosage or concentration, and volume;

c) Quantity of medicine (or number of days of use);

d) Dosage instructions;

e) Name and signature of the doctor;

f) Address of the doctor (address of the place where the doctor practices: hospital, clinic...).

Article 7. For non-trade exported and imported medicines, prescriptions from specialized doctors as stipulated in point a, b, clause 1, Section III of this Circular must accompany the medicines. Individuals handling the export and import procedures for these medicines must declare fully and present the prescription to Customs.

II. MEDICINES PROHIBITED FROM EXPORT AND IMPORT THROUGH NON-TRADE CHANNELS

1. Raw materials and auxiliary materials for medicines.

2. Medicines containing active ingredients listed in the Prohibited Export and Import Active Ingredients List attached to this Circular (Annex II).

III. SPECIFIC REGULATIONS ON THE LIST AND QUANTITY OF MEDICINES PERMITTED FOR EXPORT AND IMPORT THROUGH NON-TRADE CHANNELS

1. List of medicines permitted for non-trade export and import

a) Finished narcotic medicines as specified in the Narcotic Medicine List issued together with the Narcotic Medicine Management Regulation promulgated by the Minister of Health can only be brought into or out of the country accompanied by a prescription from a specialized doctor as stipulated in Article 5 or 6, Section I of this Circular.

b) Finished psychotropic medicines and medicines containing precursors as specified in the Psychotropic Medicine and Precursor Medicine List issued together with the Psychotropic Medicine Management Regulation promulgated by the Minister of Health are permitted for non-trade export and import accompanied by a prescription from a specialized doctor as stipulated in Article 5 or 6, Section I of this Circular.

c) Other finished medicines not included in the prohibited non-trade export and import list specified in Section II of this Circular are permitted for non-trade export and import.

2. Quantity of medicines permitted for non-trade export

a) The quantity of narcotic medicines carried when exiting the country must not exceed the quantity stated in the accompanying prescription and must not exceed the amount prescribed for seven days. In cases where the quantity exceeds the prescribed limit, approval from the Ministry of Health (Vietnam Drug Administration) is required. In addition to complying with these regulations, the person exiting the country must also comply with the regulations of the destination country.

b) Finished psychotropic medicines, medicines containing precursors, and other finished medicines permitted for non-trade export are not subject to quantity limits or frequency restrictions, but must not contravene the regulations of the importing country.

3. Quantity of medicines permitted for non-trade import

a) The quantity of narcotic medicines carried when entering the country must not exceed the quantity stated in the accompanying prescription and must not exceed the amount prescribed for seven days. In cases where the quantity exceeds the prescribed limit, approval from the Ministry of Health (Vietnam Drug Administration) is required.

b) The quantity of psychotropic medicines and medicines containing precursors imported through non-trade channels must not exceed the quantity stated in the accompanying prescription and must not exceed the amount prescribed for ten days.

c) The quantity of each other finished medicine permitted for non-trade import must not exceed 30 USD per transaction. If there are multiple types of medicines, the total value must not exceed 100 USD per transaction. The maximum number of transactions per year for an individual is three.

d) In cases where the value or number of transactions for psychotropic medicines, medicines containing precursors, and other finished medicines imported through non-trade channels exceeds the limits set forth in points b and c of this clause, based on relevant medical regulations and pharmaceutical regulations, the local Department of Health will consider allowing the importation of specialty and rare medicines as follows:

- For medicines brought into Vietnam by individuals legally entering the country, the local Department of Health at the entry port is the authority responsible for approving the importation of such medicines.

- For medicines received from abroad by individuals, the Health Department where the patient resides or has lawful temporary residence shall be the authority to consider and grant permission for receiving such medicines.

IV. ENFORCEMENT OF VIOLATIONS

1. Medicines exported or imported non-commercially contrary to the provisions of this Circular shall be treated as illegally exported or imported medicines, subject to confiscation and cancellation.

2. Organizations and individuals transporting or trading in medicines exported or imported non-commercially contrary to the provisions of this Circular shall be deemed to be engaging in illegal transportation or trade in medicines and shall be dealt with according to the law.

V. PROVISIONS ON IMPLEMENTATION

This Circular takes effect fifteen days from the date of publication in the Official Gazette, replacing Circular No. 09/2002/TT-BYT dated July 2, 2002 of the Ministry of Health guiding the implementation of Decision No. 71/2002/QĐ-TTg dated June 7, 2002 of the Prime Minister on the management of medicines for treatment purposes through non-commercial export and import channels./.