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| THE MINISTRY OF HEALTH | SOCIALIST REPUBLIC OF VIETNAM |
| No.17/2001/TT-BYT | Hanoi, August 01, 2001 |
GUIDING FOREIGN COMPANIES IN REGISTRATION FOR TRADING IN MEDICINES AND MEDICINE MATERIALS IN VIETNAM
THE MINISTER OF HEALTH
Pursuant to the Law on People’s Health Protection of July 11, 1989;
Pursuant to Decision No. 113/CT of May 9, 1989 of the Chairman of the Council of Ministers (now called the Prime Minister) on management of import and export of medicines and medicine materials for making curative medicines for human beings;
Pursuant to the Statute on preventive and curative medicines issued together with Decree No. 23/HDBT of January 24, 1991 of the Council of Ministers (now called the Government);
Pursuant to Decree No. 11/1999/ND-CP March 3, 1999 of the Government prescribing goods banned from circulation, services banned from commercial business and goods and services subject to business restriction and conditional business;
Pursuant to Decree No. 57/1998/ND-CP of July 31, 1998 of the Government detailing the implementation of the Commercial Law on import, export, processing and sale and purchase agency activities with foreign countries;
The Ministry of Health of the Socialist Republic of Vietnam guides in detail the foreign companies in registration for trading in medicines and medicine materials in Vietnam as follows:
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Article 2. Medicines and medicinal materials are stipulated in this Circular as follows:
- The medicinal materials include the materials, pharmaceutical material, excipients, capsules and immediate packing.
- The medicines includes pharmaceutical products and medicines made from medicinal herbs.
This Circular stipulates conditions, orders, procedures of registration dossiers, rights and obligations of the foreign enterprises who register the activities concerning medicines and medical materials in Vietnam
Article 4. Application objects:
Foreign enterprises not having juridical status in Vietnam (referred to as foreign enterprises) supplying Vietnam with the medicines under the import and export contracts with Vietnamese enterprises trading in medicines and medicinal materials
CONDITIONS, DOSSIERS, REGISTRATION PROCEDURES AND COMPENTENCE TO GRANT LICENSE
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1. Conditions for enterprises who have the first registration:
a) Enterprises who produce and trade in the medicines and medicinal materials are established in accordance with the local country’s law provisions.
b) Accepting to supply Vietnam with the medicines and medicinal materials under the import and export contracts through the medicine business enterprises of Vietnam.
c) The registration dossiers must be complete and valid.
d) In case of being production enterprises, they must satisfy GMP (Good Manufacturing Practice) standards. In case of being distribution enterprises, they must have licenses to trade in, import, export and preserve the medicines issued by the Competent bodies in the local country. In case, these certificates are unclear or doubtful in the authentication, the Ministry of Health of Vietnam shall appraise the enterprises’ real production and business premises in the local country (the foreign enterprises must pay every expense for the appraisal).
e) Experience in medicinal business and solvency
- The enterprises must have at least 3 years of experience in producing and trading in medicines and medicinal materials.
- The minimum turnover from medicines and medicinal materials in the most recent year (basing on the auditing report in the most recent fiscal year):
+ For the enterprises who are trading in the new medicine products: US $ 15 million per year.
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+ For the enterprises who are producing and trading the medicines made from medicinal herbs, pharmaceutical materials, excipients and immediate packing: US $ 03 million per year.
g) For the enterprises who have had indirectly engage in activities concerning medicines and medicinal materials in Vietnam; within 2 years before the date of handing the registration dossier, it is required to have no medicines of bad quality in the violation handling scope as stipulated in Article 15 of this Circular.
2. Conditions for enterprises who have the re-registration: when the license expired, the enterprises must make the re-registration dossiers and must satisfy the following conditions:
- Registration dossiers must be complete and valid
- Turnover from the medicaments supplied into Vietnam must reach the average minimum of US $ 50,000 per year.
- No law violation, no professional in the violation handling scope as stipulated in Article 15 of this Circular.
Article 6. depending on extent of violation:
Dossiers must be the originals or valid copies (with notary’s or issuing organ’s verification). The dossiers must be expressed in Vietnamese or English (in case of other languages, they must be translated into Vietnamese by a law-full translation establishment enclosed with the copy of original documents).
The dossiers shall include :
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2. The brief profile on the enterprises’ activities (Form 2 includes 1 Vietnamese and 1 English versions).
3. Documents that prove the enterprises’ establishment in the local country in which has the trading and/or producing function (Enterprise establishment license or business registration).
4. For the enterprises who are manufacturers: There must be the certificates of the GMP (Good Manufacturing Practice) or certificates of pharmaceutical products (CPP) according to the certificate system by the World Health Organization (WHO).
For the enterprises who are trading in, importing and exporting medicines: There must be the licenses for trading in, importing, exporting and preserving medicines in the local country that are issued by the competent bodies in the local country.
Those above mentioned documents must remain effective at the time of applying for registration. In the duration of operating, companies must supplement if these documents expired .
5. Confirmation of current account number of enterprises at the bank in the local country (confirmed by the bank).
6. Brief auditing reports in the most recent fiscal year (confirmed by an independent auditing body).
Article 7. Procedures and licensing competence:
The Drugs Administration Department of Vietnam shall guide accepts and appraise the registration dossier of foreign enterprises who trading in medicines and medicinal materials in Vietnam. Annually, the Drugs Administration Department of Vietnam shall inform the schedules and accept dossiers periodically (2 twice per year).
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- The notices of changing enterprise’s name or legal address.
- The concerning legal documents must be the originals or legal copies. If they are not in English, there must be a translation into Vietnamese (translated by a law-full translation establishment).
Article 9. Re - registration dossiers:
Dossiers must be the originals or valid copies (with notary’s or issuing organ’s verification). The dossiers must be expressed in Vietnamese or English (in case of other languages, they must be translated into Vietnamese by a law-full translation establishment, enclosed with the copy of original documents).
The dossiers shall include :
1. The application for re-registration (Form 3 includes 1 Vietnamese and 1 English versions).
2. The brief report of the enterprise’s activities in the medical field with Vietnam enterprises (Form 4 includes 1 Vietnamese and 1 English versions)
3. For the enterprises who are manufacturers: There must be the certificates of the GMP (Good Manufacturing Practice) or certificates of (CPP) pharmaceutical products according to the certificate system by the World Health Organization (WHO).
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Those above mentioned documents must remain effective at the time of registration application. In the duration of operating, companies must supplement if these documents expired .
4. Confirmations of current account number of enterprise at the bank in the local country (confirmed by the bank)
Article 10. Provisions on charges and fees:
In case of registration or re- registration, the foreign enterprises must pay approval expenses and fees in accordance with the current provisions. The companies must complete all procedures on handing fees and receiving licenses within 6 months from the date of being informed to be issued licenses otherwise the licenses are obviously invalid.
1. Being named as the foreign registration in case of registering medicines and medicinal materials produced by the manufacturers with the Ministry of Health of Vietnam.
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3. Organizing scientific workshops exchanging professional experience, medicinal information and advertisement according to the provisions stipulated by the Ministry of Health.
1. Observing strictly Vietnam’s law provisions, provisions of the State management by the Ministry of Health, The Drugs Administration Department of Vietnam .
2. Not supplying Vietnam with medicines banned in Vietnam, artificial medicines and poor quality medicines.
3. Not distributing medicines directly into Vietnam in any forms.
4. Being completely responsible before the State’s management organs and the users for the quality of medicines supplied into Vietnam. Compensating for the users and Vietnamese partners in case of the damages caused by the medicine supplying enterprises in accordance with the law provisions.
5. Annually reporting to the Ministry of Health of Vietnam (The Drugs Administration Department of Vietnam ) about the medicinal activities with Vietnam (Form 4).
6. Reporting to Vietnam Ministry of Health (The Drugs Administration Department of Vietnam) in case of changes and sending the relevant legal documents in the following cases:
a) Changing the Director who is mainly responsible for the activities concerning medicines and medicinal materials.
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c) Merging or separating enterprises.
7. Foreign enterprises shall be in charge of informing irregularly in the following cases:
a) Being required by the competent bodies
b) Reporting to the Ministry of Health (The Drugs Administration Department of Vietnam ) in case of recognizing that the enterprises supply Vietnam with poor - quality medicines and violate other professional provisions.
c) Reporting to the Ministry of Health (The Drugs Administration Department of Vietnam ) in case of serious events caused by the medicine that the enterprises have supplied into Vietnam. Reporting to ADR Centre about the harmful reaction of the medicine.
EXAMINATION, INSPECTION AND HANDLING OF VIOLATIONS
Article 14. Examination and inspection:
Foreign enterprises who are issued the licenses for trading in medicines and medicinal materials shall be under the inspection by the Ministry of Health (The Drugs Administration Department of Vietnam ), Health Services of provinces, centrally-run cities and under the inspection by the Ministry of Health, and the Inspectorates of the provinces and centrally-run cities.
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In the duration of working in Vietnam, the foreign enterprises that violate the laws and professional regulations shall be handed depending on the extent of violation according to the following provisions:
1. Licenses:
1.1 6 months of the probation operation (the enterprises violate professional rules at the possible operation they must make the report within 6 months, the Ministry of Health shall evaluate. If there is no violation, the enterprises will be issued the licenses);
- Quality violation at level 2 (as stipulated in Article 25 in Regulations on medicine quality management), twice within 12 months and the enterprises are sanctioned against the administrative violations by the Medical Inspectorates according to the provisions in Decree No.46/CP by the Government, those enterprises shall be warned and probated for 06 months.
- Quality violation at level 3 (as stipulated in Article 25 in Regulations on medicine quality management) three times within 12 months, those enterprises shall be warned and probated for 06 months.
1.2. Withdrawing of licenses:
- Quality violation at level 1 (as stipulated in Article 25 in Regulations on medicine quality management) and being fined by the Medical Inspectorates (according to the provisions at Points a, b in Clause 3; Points a, b in Clause 4.7 in Article 17 of Decree No. 46/CP dated August 6th, 1996 by the Government), the enterprises shall be withdrawn the licenses.
- During 6 months of probation (as stipulated in section 1.1 of this Article), if the enterprises continue supplying bad-quality medicines at level 2, they shall be withdrawn the licenses.
- Quality violation at level 2 more than 3 times within 12 months those enterprises shall be withdrawn the licenses.
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1.3. The enterprises who violates the pharmaceutical regulations and other provisions, depending on extent of violation, shall be considered and decided by the Ministry of Health (the Drugs Administration Department, Inspectorates of the Ministry of Health).
2. For other violations, the enterprises shall be handled in accordance with the current law provisions.
All licenses granted before the effective date of this Circular remains effective till the time limit as stipulated in the licenses and 3 months before the expire date of these licenses, enterprises shall have to re-register and observe all regulations on re-registration stipulated in this Circular.
Any problems arising in the course of implementation shall be reported immediately by units and localities to the Ministry of Health (the Drugs Administration Department of Vietnam) for consideration on amendments and supplements.
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FOR THE MINISTER OF HEALTH
VICE MINISTER
Le Van Truyen
(This translation is for reference only)
To:
- The Ministry of Health of the Socialist Republic of Vietnam
- The Drugs Administration Department of Vietnam
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Address:
Tel:
Fax:
Address:
Tel:
We apply for business registration with the Ministry of Health of the Socialist Republic of Vietnam to trade in medicines and medicine materials in Vietnam. If being licensed, we shall commit ourselves to strictly observing the provisions of Vietnamese law, pharmaceutical statutes and regulations issued by the Ministry of Health and to being inspected by relevant competent management bodies of Vietnam.
Date...........................
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(Signature with the full name and sealed)
1. Name of Business:
2. Nationality of Business:
3. Address:
Tel: E-mail:
Fax:
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- Trading business:
- Producing business:
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5. Trading and producing sectors allowed to be engaged in the local country:
Pharmaceutical:
Producing
Trading
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- Products:
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- Finished medicine products made from medicinal herbs:
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Chemicals:
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Other trading and producing sectors (if any):
6. Date of establishment:
7. Place of establishment:
8. Charter capital:
9. Operating capital:
10. Number of account ........... at....... Bank, Tel: ................, Fax...............
11. Number of license:............... Expire date of the license:..............
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13. Turnover from pharmaceutical trading in latest 3 years:
14. Total employees of the business:
15. Total pharmaceutical employees:
16. Director of the business:
- Name and surname:
- Professional qualification:
17. Lawfull person authorized who takes responsibility for activities of the business in Vietnam (if any):
Name, title:
Professional qualification:
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I ensure for the trustfulness of the above mentioned contents, if wrong, I shall take responsibility for them.
Date.....................
(General) Director of business
(Signature, full name, seal)
REPORT ON ACTIVITIES RELATED TO MEDICINES AND MEDICINE MATERIALS WITH VIETNAMESE PARTNERS
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1. Vietnamese businesses having trading relations (if any):
2. Total turnover from volume sold into Vietnam (including volume sold through other foreign companies):
Note: This total turnover calculated according to implemented contracts, excluding contracts never or haven’t been implemented.
3. List of medicines and medicine materials sold into Vietnam: (clearly stating name of medicine, kind of medicine, model of packing, content, concentration)
4. List of medicines and medicines having registered number for circulating in Vietnam.
5. Report on other activities in the pharmaceutical sector with Vietnam.
Date..............
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(Signature )
To: The Ministry of Health of the Socialist Republic of Vietnam
Business:
Address:
Tel:
Fax:
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We have been granted license to trade in medicines and medicine materials in Vietnam by the Ministry of Health of the Socialist Republic of Vietnam.
Number of licenses granted for the first time: ..............Granting date:
Number of effective licenses:............Expire date:
We apply for registration with the Vietnam’s Ministry of Health to be re-granted licenses for trading in medicines and medicine materials in Vietnam. We commit ourselves to observing all professional statues and regulations of Vietnam’s Law.
Your faithfully,
Date...................
Director
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(For 2 years)
To: The Ministry of Health of the Socialist Republic of Vietnam
Name of business:
Address:
Tel:.................................Fax:..........................E-mail:
Contents of report:
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- License for opening rep. office No.: ............Date of granting:
- Address:
- Head of the rep. office:
2. Having business relations with the following Vietnamese businesses:
3. Report on turnover:
Year...
Year...
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a/ Materials:
Name of materials
Unit
Volume
Turnover
Year
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Total
Year
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b/ Finished products:
Name of medicine
Registered number (if any)
Main active substances (if haven�t been registered)
Unit
Volume
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Year
Total
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Year
Total
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4. Report on violations of statutes, volume of quality-violated medicine lots that have been sold into Vietnam and settlement results.
We ensure for trustfulness of the above mentioned contents, if wrong we shall take responsibility for them.
Date.................
Director
(Signature with the full name)
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Year....
To: The Ministry of Health of the Socialist Republic of Vietnam
Name of Business:
Address:
Tel:...............Fax:.........................E-mail:
Contents of report:
1. Representative office:
- License for opening Rep. office No.:.................... Date of granting:
- Address:
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2. Having business relations with the following Vietnamese businesses:
3. Report on turnover:
- Total turnover from medicines sold into Vietnam (according to contracts, converted into US$)
- Report on violations of statues, volume of quality-violated medicine lots that have been sold into Vietnam and results of handling.
We ensure for trustfulness of the above mentioned contents, if wrong, we shall take responsibility for them.
Date.................
Director
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- 1Circular No. 47/2011/TT-BYT of December 21, 2011, on amendment and supplement of a number of articles of Circular No.17/2001/TT-BYT Dated August 01, 2001 of the Ministry of Health guiding foreign companies in registration for trading medicines and medicine materials in Vietnam and Circular No.10/2003/TT-BYT on December 16, 2003 guiding the foreign companies for registration on the operation of trading vaccines, medical biological products with Vietnam
- 2Circular No. 47/2011/TT-BYT of December 21, 2011, on amendment and supplement of a number of articles of Circular No.17/2001/TT-BYT Dated August 01, 2001 of the Ministry of Health guiding foreign companies in registration for trading medicines and medicine materials in Vietnam and Circular No.10/2003/TT-BYT on December 16, 2003 guiding the foreign companies for registration on the operation of trading vaccines, medical biological products with Vietnam
- 1Decree No. 11/1999/ND-CP of March 03, 1999, on goods banned from circulation, commercial services banned from provision; goods and commercial services subject to business restriction or conditional business
- 2Decree of Government No. 57/1998/ND-CP, promulgated by the Government, detailing the implementation of the commercial law regarding the goods import, export, processing, and sale and purchase agency activities with foreign countries
- 3Law No. 58/1997/L-CTN of May 10, 1997 The Commercial Law
- 4Decree No. 46-CP of August 06, 1996, of the GovernmeAnt on sanctions against administrative violations in the field of state management over public health
- 5Law No. 21-LCT/HDNN8 of June 30, 1989, of people’s health
Circular no. 17/2001/TT-BYT of August 01, 2001 guiding foreign companies in registration for trading in medicines and medicine materials in vietnam
- Số hiệu: 17/2001/TT-BYT
- Loại văn bản: Thông tư
- Ngày ban hành: 01/08/2001
- Nơi ban hành: Bộ Y tế
- Người ký: Lê Văn Truyền
- Ngày công báo: Đang cập nhật
- Số công báo: Đang cập nhật
- Ngày hiệu lực: Kiểm tra
- Tình trạng hiệu lực: Kiểm tra