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THE MINISTRY OF HEALTH
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SOCIALIST REPUBLIC OF VIETNAM
Independence- Freedom- Happiness
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No.17/2001/TT-BYT
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Hanoi, August 01, 2001
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CIRCULAR
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.
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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.
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
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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
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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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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).
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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.
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.
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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.
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.
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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.
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.
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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.
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.
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FOR THE MINISTER OF HEALTH
VICE MINISTER
Le Van Truyen
(This translation
is for reference only)
Form No.1
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
-
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)
Form No.2a
BUSINESS
RECORD
1. Name of Business:
2. Nationality of
Business:
3. Address:
Tel: E-mail:
Fax:
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- Trading business:
- Producing
business:
�
�
5. Trading and
producing sectors allowed to be engaged in the local country:
Pharmaceutical:
Producing
Trading
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�
�
- Products:
�
�
- Finished medicine
products made from medicinal herbs:
�
�
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)
Form No.2b
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 )
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:
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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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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:
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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)
Form No.5
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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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