Thông tư 39/2013/TT-BYT Quản lý thuốc chữa bệnh cho người

OFFICIAL GAZETTE
Issue nos 06-08__March 2014

(Công Báo nos 303-326/2014)

Prescribing the management of curative medicines for human use which are imported and exported through the non-commercial channel¹

Pursuant to June 14, 2005 Pharmacy Law No. 34/2005/QH11;

Pursuant to December 9, 2000 Law No. 23/2000/QH10 on Drug Prevention and Fight;

Pursuant to the Government’s Decree No. 58/2003/ND-CP of May 29, 2003, on controlling the import, export and transit via the Vietnamese territory of narcotics, pre-substances, addictive drugs and psychotropic drugs;

Pursuant to the Government’s Decree No. 63/2012/ND-CP of August 31, 2012, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

Pursuant to the Prime Minister’s Decision No. 42/2013/QD-TTg of July 15, 2013, providing the management of drugs for human use which are imported and exported through the non-commercial channel, and amending and supplementing a number of articles of the Regulation on import of drugs without registration numbers in Vietnam, promulgated together with the Prime Minister’s Decision No. 151/2007/QD-TTg of September 12, 2007;

At the request of the director of the Drug Administration;

The Ministry of Health promulgates the Circular prescribing the management of curative medicines for human use which are imported or exported through the non-commercial channel.

Article 1. Scope of regulation

1. This Circular prescribes activities related to the import or export of medicines for human use (below referred to as medicines for short) through the non-commercial channel.

2. Curative medicines for human use which are imported and exported through the non-commercial channel stipulated in this Circular include:

a/ Medicines which are gifts or donation sent by organizations and individuals in Vietnam to overseas organizations and individuals, or vice versa;

b/ Medicines which pertain to goods of diplomatic representations and international organizations in Vietnam or Vietnamese diplomatic representations and organizations abroad and people working in such representations and organizations. Cases where medicines are exempted from customs procedures must comply with treaties to which Vietnam is a contracting party;

c/ Medicines in personal luggages of persons on entry or exist consigned with bills of lading, goods carried along by persons on entry or exist.

3. Medicines imported or exported through other non-commercial channels (medicines imported, exported for use as samples for registration, standard samples and substances for testing and research, or donated as aid or humanitarian aid) are not governed by this Circular.

Article 2. General provisions on non-commercial imported or exported medicines

1. Non-commercial imported or exported medicines shall be used only for treatment of diseases of individuals who request the non-commercial import or export of medicine and individuals working in organizations requesting the non-commercial import or export of medicines or their family members. Non-commercial imported medicines may neither be sold in the market nor used for any other illegal purposes.

2. Individuals and organizations requesting the non-commercial import or export of medicines shall take responsibility for the origin and quality of such medicines.

3. Non-commercial imported or exported medicines must have labels indicating their appellations, active ingredients, concentrations, contents and expiry date.

4. Apart from complying with this Circular, persons on exit shall also abide by the law of the countries which they enter.

Article 3. Medicine banned from non-commercial import or export

1. Medicine materials.

2. Medicines containing active ingredients on the list of active ingredients banned from import or export for use as medicines prescribed in the Minister of Health’s Circular No. 47/2010/TT-BYT of December 21, 2010, guiding medicine import and export, documents amending and supplementing this Circular, and official letters of the Ministry of Health on the suspension of medicine use and import.

Article 4. Quota quantity of medicines eligible for non-commercial import and export

1. The quantity of finished addictive medicines carried along by individuals upon their exit or entry must neither exceed the quantity written in the enclosed doctor prescriptions nor the quantity prescribed for 7 days.

2. The quantity of finished psychotropic drugs and pre-substances used as medicines that are imported through the non-commercial channel must neither exceed the quantity written in the enclosed doctor prescriptions nor the quantity prescribed for 7 days.

3. Other finished medicines are permitted for non-commercial export in unlimited quantities and with an unlimited number of times of exportation, permitted for non-commercial import but the total value of those medicines must not exceed USD 100 per importation (according to the inter-bank exchange rate). Each individual or organization may receive medicines three times a year at most.

4. When the quantity of non-commercial imported or exported medicines exceeds the quota quantity specified in Clauses 1, 2 and 3 of this Article, a permit of a competent health management agency defined in Article 6 of this Circular is required.

Article 5. Dossiers for non-commercial import or export of medicines

1. A dossier for non-commercial import or export of medicines specified in Clauses 1 and 2, Article 4 of this Circular comprises:

a/ A prescription or medical examination book: A prescription made up by a Vietnamese doctor or an outpatient medical examination book made according to the form specified in Appendix I to the Minister of Health’s Decision No. 04/2008/QD-BYT of February 1, 2008, promulgating the Regulation on prescription of medicines for outpatient treatment. A prescription or medical examination book made up by a foreign doctor must be written in English or Vietnamese. If in other languages, they must be translated into English or Vietnamese and must have the following contents:

- Name and age of the patient;

- Appellation of the medicine, its content or concentration and volume;

- Quantity of the medicine (or the number of days for medicine use);

- Dosage;

- Full name and signature of the physician;

- Address of the doctor (address of the doctor’s practice place: hospital, clinic, etc.).

b/ Individuals shall, when carrying out relevant non-commercial import or export procedures or upon their entry or exit, declare all the medicines and present their prescriptions to the customs offices.

2. A dossier for non-commercial import or export of medicines specified in Clauses 1 and 2, Article 4 of this Circular comprises:

a/ An application form (Form 1a/PMD or 1b/PMD);

b/ A copy of the identity card or passport of the person importing or exporting the medicines through non-commercial channel (to produce the original of the identity card or passport when carrying out customs procedures);

c/ Attached documents: A prescription or medical examination book or medical records or related documents;

d/ A prescription made up by a Vietnamese doctor or an outpatient medical examination book, which is made according to the form provided in Appendix I to the Minister of Health’s Decision No. 04/2008/QD-BYT of February 1, 2008, promulgating the Regulation on prescription of medicines for outpatient treatment. A prescription made up by a foreign doctor, medical examination book or medical record must have the contents specified in Clause 1 of this Article.

Article 6. Order and competence to permit non-commercial import or export of medicines

1. Individuals shall directly carry out import or export procedures for non-commercial imported or exported medicines satisfying the conditions on quota quantity in Clauses 1, 2 and 3, Article 4 of this Circular at border-gate customs offices.

2. For non-commercial import or export of medicines by individuals which have a value or are received in a number of times exceeding the limits specified in Clauses 2 and 3, Article 4 of this Circular, provincial-level Health Departments shall, based on relevant professional medical regulations and pharmaceutical regulations, consider and permit the receipt of medicines for treatment as follows:

a/ For medicines which are carried along by individuals lawfully entering or leaving Vietnam, the provincial-level Health Department of the locality where exists the border gate of exit or entry or the provincial-level Health Department of the locality where the patient lives or lawfully stays shall consider and permit the receipt;

b/ For medicines which are sent from abroad to individuals, the provincial-level Health Department of the locality where the patient lives or lawfully stays shall consider and permit the receipt.

3. The Ministry of Health (the Drug Administration) shall permit non-commercial import or export of medicines by organizations based on relevant professional medical regulations and pharmaceutical regulations.

4. The Ministry of Health (the Drug Administration) shall permit the non-commercial import or export of medicines which have a value or are received in a number of times higher than the limits specified in Clause 1, Article 4 of this Circular based on relevant professional medical regulations and pharmaceutical regulations.

5. Within 7 working days, a competent agency shall issue a reply, grant an import or export permit, or in case of refusal, issue a written reply, clearly stating the reason.

6. For non-commercial import or export of medicines in excess of the limits specified in Clause 4, Article 4 of this Circular, pending a written permit of the competent health management agency specified in Clauses 2, 3 and 4 of this Article, individuals and organizations may receive the quantity of medicines within the limits specified in Clauses 1, 2 and 3, Article 4 of this Circular.

Article 7. Handling of violations

1. Medicines which are imported or exported through the non-commercial channel in contravention of this Circular shall be treated as illegal imports or exports and confiscated and handled under the Government’s Decree No. 176/2013/ND-CP of November 14, 2013, on sanctioning of administrative violations in the medical sector, and other relevant laws.

2. Organizations or individuals that transport or trade in non-commercial imported or exported medicines in contravention of the provisions of this Circular shall be regarded as illegal transporters or traders, and be handled according to the Government’s Decree No. 176/2013/ND-CP of November 14, 2013, on sanctioning of administrative violations in the medical sector, and other relevant laws.

Article 8. Transitional provisions

1. Official letters permitting non-commercial import or export of medicines granted by the Ministry of Health (Drug Administration) or provincial-level Health Departments to individuals and organizations under the Minister of Health’s Circular No. 01/2007/TT-BYT of January 17, 2007, guiding the management of curative medicines for human use which are imported or exported through the non-commercial channel, may remain in effect until the expiration of their validity duration.

2. In case the legal documents referred to in this Circular are amended, supplemented or replaced, the amending, supplementing or replacing documents shall be complied with.

Article 9. Implementation responsibility

The director of the Drug Administration and directors of provincial-level Health Departments shall organize the implementation of this Circular.

Article 10. Effect

1. This Circular takes effect on January 1, 2014.

2. The Minister of Health’s Circular No. 01/2007/TT-BYT of January 17, 2007, guiding the management of curative medicines for human use which are imported or exported through the non-commercial channel, cease to be effective from the effective date of this Circular.

Any problems arising in the course of implementation should be promptly reported to the Ministry of Health (Drug Administration) for guidance or amendment and supplementation.-

For the Minister of Health
Deputy Minister
PHAM LE TUAN