Thông tư 17/2001/TT-BYT của Bộ Y tế về việc hướng dẫn doanh nghiệp nước ngoài đăng ký hoạt động về thuốc và nguyên liệu làm thuốc tại Việt Nam

IRCULAR

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:

Chapter I

GENERAL PROVISIONS

Article 1.

1. As a special item of goods, medicine is the conditional business goods professionally controlled by the Ministry of Health of Vietnam. Foreign enterprises must register the activities concerning medicines and medicinal materials in Vietnam so as to ensure the imported medicines with good quality, safety and effect for the users.

2. The foreign enterprises who can satisfy the conditions stipulated in this Circular shall be issued the foreign companies’ operation license on medicines and medicinal materials ( hereinafter referred to as "License") by the Ministry of Health of Vietnam.

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.

Article 3. Adjustment scope:

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

Chapter II

CONDITIONS, DOSSIERS, REGISTRATION PROCEDURES AND COMPENTENCE TO GRANT LICENSE

Article 5.Conditions:

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.

+ For the enterprises who are producing the new medicine products: US $ 05 million per year.

+ 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 :

1. The registration application of the foreign enterprises trading in medicines and medicinal materials (Form 1 includes 1 Vietnamese and 1 English versions).

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).

Within 03 months from the date of receiving valid dossiers, the Ministry of Health shall issue licenses. In case, licenses are not issued, the Ministry of Health (The Drugs Administration Department of Vietnam) must clearly explain in writing reasons therefor.

Article 8.In case of changing name or address, the enterprises must give proposal and send the enclosed legal document to the Ministry of Health (The Drugs Administration Department of Vietnam ):

- 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).

For the enterprises who are only trading in importing and exporting medicines: The licenses of trading, importing exporting and preserving medicines in the local country shall be issued by the competent bodies of that country.

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.

Article 11.The licenses take effect within 02 years from the date of signing. If the enterprises want to continue working, they shall have to carry out the re-registration procedures 3 months before the licenses expired .

Chapter III

RIGHTS AND RESPONSIBILITIES OF FOREIGN ENTERPRISES REGISTERING THE ACTIVITIES CONCERNING MEDICINES AND MEDICINAL MATERIALS IN VIETNAM

Article 12.Foreign enterprises who register activities concerning medicines and medicinal materials in Vietnam shall have the following rights:

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.

2. Supplying Vietnam with the medicines and medicinal materials under the type of signing import and export contracts with medicine import-export enterprises of Vietnam

3. Organizing scientific workshops exchanging professional experience, medicinal information and advertisement according to the provisions stipulated by the Ministry of Health.

Article 13.Foreign enterprises who register medicine and medicinal materials in Vietnam shall have the following obligations:

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.

b) Terminating the medicine trade with Vietnam.

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.

Chapter IV

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.

Article 15.Handling of Violations:

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.

- In case where the enterprises are withdrawn licenses or they are not granted licenses because of violation they can only re-hand in the registration dossiers after at least 2 years (the registration dossiers are stipulated the same as the first registration).

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.

Article 16.The Drugs Administration Department and Inspectorates of the Ministry of Health regularly exchange information about the granting of licenses and violations, sanctions against administrative violations. The Inspectorates of the Health Services of provinces and centrall-run cities shall inform the result of handling and punishment for the violations in the controlled regions to the Inspectorates of the Ministry of Health for coordination, synthesization and announcement nationwide.

Chapter V

IMPLEMENTATION PROVISIONS

Article 17.This Circular takes effect 15 days after its date of signing and replaces Circular No. 07/BYT-TT of March 30, 1991 of the Ministry of Health guiding the registration of foreign companies being allowed to import and export of medicines and medicine materials with organizations and companies of the Socialist Republic of Vietnam.

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.

(This translation is for reference only)

Form No.1

REGISTRATION APPLICATION OF FOREIGN COMPANIES FOR TRADING IN MEDICINES AND MEDICINE MATERIALS IN VIETNAM

Name of Business:

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.

Form No.2a

BUSINESS RECORD

1. Name of Business:

2. Nationality of Business:

3. Address:

Tel: E-mail:

Fax:

4. Type of business:

5. Trading and producing sectors allowed to be engaged in the local country:

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:..............

12. Name and address of the competent licensing bodies in the local country:

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:

The authorized term:

I ensure for the trustfulness of the above mentioned contents, if wrong, I shall take responsibility for them.

Form No.2b

REPORT ON ACTIVITIES RELATED TO MEDICINES AND MEDICINE MATERIALS WITH VIETNAMESE PARTNERS

(For enterprise making new registration)

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.

Form No.3

REGISTRATION APPLICATION OF FOREIGN COMPANIES FOR TRADING IN MEDICINES AND MEDICINE MATERIALS IN VIETNAM

To:The Ministry of Health of the Socialist Republic of Vietnam

Business:

Address:

Tel:

Fax:

E-mail:

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,

Form No.4

OPERATION REPORT

(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:

1. Representative office:

- 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:

Analysis:

a/ Materials:

b/ Finished products:

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.

Form No.5

OPERATION REPORT

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:

- Head of the rep. office:

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.