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MINISTRY OF HEALTH
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SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No.: 45/2011/TT-BYT
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Hanoi, December 21, 2011
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CIRCULAR
AMENDING AND SUPPLEMENTING A
NUMBER OF ARTICLES OF DECISION NO.1570/2000/QD-BYT DATED 22/05/2000 OF MINISTER
OF HEALTH ON THE APPLICATION OF THE PRINCIPLES OF "GOOD LABORATORY
PRACTICE"; DECISION NO.2701/2001/QD-BYT DATED 29/06/2001 OF MINISTER OF HEALTH
ON THE APPLICATION OF THE PRINCIPLES OF "GOOD STORAGE PRACTICE"; CIRCULAR
NO.06/2004/TT-BYT ON 28/5/2004 GUIDING THE PRODUCTION AND PROCESSING OF DRUGS; DECISION
NO. 3886/2004/QD-BYT ON 13/11/2004 OF THE MINISTRY OF HEALTH ON THE APPLICATION
OF THE PRINCIPLES, STANDARDS OF "GOOD MANUFACTURE PRACTICE" ACCORDING
TO RECOMMENDATION OF WORLD HEALTH ORGANIZATION; CIRCULAR NO.13/2009/TT-BYT DATED 01/9/2009 OF THE
MINISTRY OF HEALTH GUIDING DRUG ADVERTISING AND INFORMATION OPERATIONS; CIRCULAR
NO.22/2009/TT- BYT DATED 24/11/2009 OF THE MINISTRY OF HEALTH REGULATING THE DRUG
REGISTRATION; CIRCULAR NO.47/2010/TT-BYT DATED 29/12/2010 GUIDING THE EXPORT
AND IMPORT OF DRUGS AND PACKAGING DIRECTLY EXPOSING WITH DRUGS
Pursuant
to the Pharmacy Law No.34/2005/QH11 dated June 14, 2005;
Pursuant
to Decree No.188/2007/ND-CP dated 27/12/2007 of the Government regulating
functions, duties, powers and organizational structures of the Ministry of Health;
Ministry
of Health guides the application of the principles and standards of "Good
Laboratory Practice", "Good Storage Practice," "Good Manufacture
Practice", guidance of drugs production and processing, drug advertising
information, guidance of the export and import of drugs and packaging in direct
contact with drugs, drug registration regulations as follows:
Article 1. To amend and supplement some Articles of
Decision No.1570/2000/QD-BYT on 22/05/2000 of the Minister of Health on the
application of the principles of "Good Laboratory Practice" as
follows:
1.
To amend and supplement Point 2.2, Clause 2 of Part III as follows:
"2.2.
Examination and issuance of certificates
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After
the establishments self-examine and assess that they obtain the principle of
"Good Laboratory Practice", shall send 01 set of dossier of
examination registration to Drug Administration - Ministry of Health.
Registration dossier comprises:
-
For registration of the first examination:
(1)
A registration application for examination "Good Laboratory Practice"
(Form 01/GLP Appendix 1);
(2)
A copy of establishment license or business registration certificate or
investment certificate signed by the owner of the establishment and stamped for
certification by the establishment;
(3)
Organization diagram and staffing of the establishment;
(4)
Diagram of location and design of the laboratory;
(5)
Analysis equipment list of the establishment;
(6)
The list of tests (methods) and/or products of the establishment making quality
examination;
-
In case of registration for re-examination:
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(2)
A copy of establishment license or business registration certificate or
investment certificate signed by the owner of the establishment and stamped for
certification by the establishment;
(3)
A Report of overcoming existence problems at the previous examination;
(4)
A Report of the changes of the establishment within 03 years of implementing "Good
Laboratory Practice" and related documents, if any.
2.2.2.
Examination and issuance of certificate
a)
Competence to appraise dossier, examination, issuance of certificate and
standards of the examiners:
Competence:
-
Ministry of Health makes a decision to set up the team of examination and
issuance of certificate meeting the principles of "Good Laboratory
Practice" for the Central Institute for Drug Test, Drug Test Institute in Ho Chi Minh City and the National Institute for Calibration of the Vaccines and Medical
Biological Products.
-
Drug Administration makes a decision to set up the team of examination and
issuance of certificate meeting the principles of "Good Laboratory
Practice" for the Centers of testing pharmaceuticals, cosmetics of provinces
and cities directly under the Central government, the establishments of testing
of the enterprises, the independent laboratories, or private laboratories.
*
Standards of the examiners:
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Have determined and scientific methods of inspection and examination,
determination; with the ability to rapidly detect errors of the establishments
at the same time take the persuasive measures to help the establishments to overcome
the shortcomings.
-
Honest, objective and strictly abide by regulations and provisions of laws in
the exmination process.
-
Have good health, not getting infectious diseases.
b)
Appraisal of dossiers and organization of the examination
-
After receipt of the registration dossier for examination of the establishment
as stipulated in point 2.2.1 of this Part, the Drug Administration conducts the
appraisal of dossier (with minute of appraisal).
-
Within 05 working days after receipt of dossier and appraisal fees as
prescribed, the management agency must inform the establishment on the status
of dossier if it does not meet the requirements or the examination plan.
-
Within 20 working days from the date of notification of the examination plan, the
management agency must conduct real examination at the establishment.
c)
Examination, handling of examination results and issuance of certificate Examination
-
The examination team shall check all the activities of the establishments
according to the principles of "Good Laboratory Practice" and the current
professional regulations.
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-
The examination minute must be specified the existence in the application of
principles of "Good Laboratory Practice" at the establishment. In
case of disagreement with the opinions of examination team, the minute must be
specified all of the reserved comments of the establishment. The minute shall
be signed by manager of the establishment and the head of the examination team;
made into 03 copies: 01 copy stored at the establishment, 02 copies kept at the
Drug Administration.
*
Handling of examination results and issuance of certificates:
-
Case 1: If the examined establishment meets the principles of "Good
Laboratory Practice", the competent management agency under the provisions
section a of point 2.2.2 of this Part shall issue a certificate of achieving
the principles of "Good Laboratory Practice" within 05 working days
from the end of the examination.
-
Case 2: For the examined establishment meets basically the principles of
"Good Laboratory Practice", and there are still some existence which
do not affect the test results and can be overcome in a short term, the
examination team will require the establishment to report the recovery and
repair.
The
establishment must fix, repair and report the results of overcoming the existence
that examination team has raised in the minute submitted to the Drug Administration.
The
head of examination team synthesizes, reports to the competent persons for considering
issuing certificate reaching the principles of "Good Laboratory
Practice" or the competent management agency has to announce the official
results to the establishment within 05 working days after receipt of the report
of overcoming.
Over
02 months after the end of the examination, if the establishment fails to send
regular report of overcoming, it must conduct filing registration for
examination from the beginning.
-
Case 3: For the establishments not meeting the principles of "Good
Laboratory Practice", the establishment must conduct overcome, repair existence.
After self-examinig, assessing meeting the requirements, the establishments
conduct to file registration for examination from the beginning.
Registration
for reexamination
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-
Once every 03 years, 02 months before the certificate of meeting the principles
of "Good Laboratory Practice" expires, the establishment shall apply
for registration of reexamination, except for irregular cases required by the establishment
or Ministry of Health (Drug Administration).
-
After the establishment filed dossier for registration of reexamination, it is still
allowed to test drug under the extent specified in the certificate of "Good
Laboratory Practice” and the certificate of eligibility for drug trading (being
valid).
-
During the examination, if it is detected that the establishment has existence at
the level to seriously affect the test results or operations of the establishment,
head of the examination team makes minute, reports to the competent persons for
making decision on formal handling.".
2.
To amend and supplement registration form "Good Laboratory Practice"
in Section E, Part IV: Form 01/GLP, Appendix 1.
Article 2. To amend and supplement some Articles of
Decision No.2701/2001/QD-BYT dated 29/6/2001 of the Minister of Health on the
implementation of application of the principles of "Good Storage
Practice" as follows:
1.
To amend and supplement Clause 2.2, Section 2 of Part III as follows:
"2.2.
Registration for examination:
After
the establishments self-examine and assess that they obtain the principle of
"Good Storage Practice", shall send 01 set of dossier of examination
registration to the competent agency provided for in point 2.3.1 of this Part.
Registration dossier comprises:
-
For registration of the first examination:
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(2)
A copy of establishment license or business registration certificate or
investment certificate signed by the owner of the establishment and stamped for
certification by the establishment;
(3)
A Data, programs, and summary reports of training, retraining "Good
Storage Practice" at the establishment;
(4)
A Organization diagram of the establishment;
(5)
A Diagram of location and design of the store;
(6)
A Storage equipment list of the establishment;
(7)
A list of objects stored and storage conditions, respectively;
-
In case of registration for reexamination:
(1)
A written registration for re-examination "Good Storage Practice"
(Form 02/GSP Appendix 2);
(2)
A copy of establishment license or business registration certificate or
investment certificate signed by the owner of the establishment and stamped for
certification by the establishment;
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(4)
A Report of the changes of the establishment within 03 years of implementing
"Good Storage Practice" and related documents, if any.
2.3.
Competence to appraise dossier, examination, issuance of certificate and
standards of the examiners:
2.3.1. Competence:
a)
Drug Administration is responsible for receiving and appraising dossiers of
registration, establishing the examination team, organizing the examination in
reality at the establishments and issuing certificates meeting the principles
of "Good Storage Practice" for establishments making drug storage
service.
-
The Health Departments of provinces, cities under central authority where the
stores of the establishments registering for examination of "Good Storage
Practice" are located are responsible for receiving and appraising
dossiers of registration, establishing the examination team, organizing the
examination in reality at the establishments and issuing certificates meeting
the principles of "Good Storage Practice" for the remaining cases.
2.3.2. Standards of
the examiners:
- Those who have
university degrees or higher, with experience in the management of
pharmaceuticals in general and the particular drug storage.
- Those who have
university degrees or higher, with experience in pharmaceutical management in
general and the quality examination of drugs in particular.
- Have determined and
scientific methods of inspection and examination, determination; with the
ability to rapidly detect errors of the establishments at the same time take
the persuasive measures to help the establishments to overcome the
shortcomings.
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- Have good health,
not getting infectious diseases.
2.4. Appraisal of
dossiers and organization of the examination
- After receipt of
the registration dossier for examination of the establishment as stipulated in clause
2.2 of this Part, the competent management agency as prescribed point 2.3.1 of
this Part conducts the appraisal of dossier (with minute of appraisal).
- Within 05 working
days after receipt of dossier and appraisal fees as prescribed, the management
agency must inform the establishment on the status of dossier if it does not
meet the requirements or the examination plan.
- Within 20 working
days from the date of notification of the examination plan, the management
agency must conduct real examination at the establishment.
2.5.
Examination, handling of examination results and issuance of certificate Examination
-
The examination team shall check all the activities of the establishments
according to the principles of "Good Storage Practice" and the
current professional regulations.
-
The the establishments registering for examination of "Good Storage
Practice" must report by the diagrams, diagrams and brief data on the
operation, the application of principles of "Good Storage Practice".
-
The examination minute must be specified the existence in the application of
principles of "Good Storage Practice" at the establishment. In case
of disagreement with the opinions of examination team, the minute must be
specified all of the reserved comments of the establishment. The minute shall
be signed by manager of the establishment and the head of the examination team;
made into 03 copies: 01 copy stored at the establishment, 02 copies kept at the
management agency making decision on establishment of the examination team.
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-
Case 1: If the examined establishment meets the principles of "Good
Storage Practice", the competent management agency under the provisions
section a of point 2.3.1 of this Part shall issue a certificate of achieving
the principles of "Good Storage Practice" within 05 working days from
the end of the examination.
-
Case 2: For the examined establishment meets basically the principles of
"Good Storage Practice", and there are still some existence which do
not affect the stored drugs quality and can be overcome in a short term, the
examination team will require the establishment to report the recovery and
repair.
The
establishment must fix, repair and report the results of overcoming the
existence that examination team has raised in the minute submitted to the
management agency making decision on establishment of the examination team.
The
head of examination team synthesizes, reports to the competent persons for
considering issuing certificate reaching the principles of "Good Storage
Practice" or the management agency has to announce the official results to
the establishment within 05 working days after receipt of the report of
overcoming.
Over
02 months after the end of the examination, if the establishment fails to send
regular report of overcoming, it must conduct filing registration for examination
from the beginning.
-
Case 3: For the establishments not meeting the principles of "Good Storage
Practice", the establishment must conduct overcome, repair existence.
After self-examining, assessing meeting the requirements, the establishments
conduct to file registration for examination from the beginning.
Registration
for reexamination
-
Certificate of achieving the principles of "Good Laboratory Practice"
is valid for 03 years from the date of signing.
-
Once every 03 years, 02 months before the certificate of meeting the principles
of "Good Storage Practice" expires, the establishment shall apply for
registration of reexamination, except for irregular cases required by the
establishment or the management agency.
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-
During the examination, if it is detected that the establishment has existence
at the level to seriously affect the quality of drugs to be stored, head of the
examination team makes minute, reports to the competent persons for making
decision on formal handling.".
2.
To amend Form 03-GSP/MB: Form 01/GSP
and 02/GSP Appendix 2.
3. Certificate achieving the principles of "Good
Storage Practice" is valid for 03 years from the date of signing. The
certificates which are issued previously by Drug Administration with effective
term of 02 years are continued to extend their operating time for 01 years from
the expiration date. Drug Administration issues the decision to extend together
with the list of establishments to be extended in the certificates of achieving
the principle of "Good Storage Practice."
Article 3. To amend and supplement some Articles of
Circular No.06/2004/TT-BYT dated 28/05/2004 of the Ministry of Health guiding
drug production and processing as follows:
1.
To amend and supplement Point 1.1. Clause 1, Section I as follows:
"1.1.
Subjects of application: Organizations, enterprises and individuals to produce
pharmaceuticals."
2.
To annul Point 1.3, Clause 1 of Section II.
3.
To amend and supplement Clause 1 of Section III as follows:
"1.
Conditions for being named the processing receiver
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4.
To amend and supplement Point 1.1, Clause 1 of Section V as follows:
"1.1.
Drug registration dossier of production and processing includes 01 original and
02 copies of standard, methods of testing."
5.
To amend and supplement Point 2.1, Clause 2 of Section V as follows:
"2.1.
Drug registration dossier of the domestic production establishments ordering
the production processing of drugs has registration numbers for circulation in Vietnam."
6.
To supplement in Point 2.1, Clause 2 of Section V as follows:
"2.1.
Specific technical document is made as prescribed in Article 19 of Circular 22/2009/TT-BYT
dated 24/11/2009 of the Ministry of Health guiding the registration of drugs."
7.
To supplement in Point 2.2, Clause 2 of Section V as follows:
"2.2.
Specific technical document is made as prescribed in Article 19 of Circular
22/2009/TT-BYT dated 24/11/2009 of the Ministry of Health guiding the
registration of drugs."
Article 4. To amend and supplement some Articles of
Decision
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1.
To amend and supplement Clause 2 of Section II as follows:
"2.
Procedures for registration for examination:
a)
Registration for examination:
After
the establishments self-examine and assess that they obtain the principle,
standards of "Good Manufacture Practice", shall send 01 set of
dossier of examination registration to the Drug Administration - Ministry of
Health. Registration dossier comprises:
-
The case of registration for the first examination:
(1)
A registration application for examination "Good Manufacture
Practice" (Form 01/GMP Appendix 3);
(2)
A copy of establishment license or business registration certificate or
investment certificate signed by the owner of the establishment and stamped for
certification by the establishment;
(3)
Organization diagram and staffing of the establishment;
(4)
Data, programs, and summary reports of training, training "Good
Manufacture Practice" at the establishment.
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(6)
Existing equipment list of the factory;
-
In case of registration for reexamination:
(1)
A written registration for re-examination "Good Manufacture Practice"
(Form 02/GMP Appendix 3);
(2)
A copy of establishment license or business registration certificate or
investment certificate signed by the owner of the establishment and stamped for
certification by the establishment;
(3)
A Report of overcoming existence problems at the previous examination;
(4)
A Report to summarize activities of the establishment for the past 03 years;
(5)
A Report of the changes of the establishment within 03 years of implementing
"Good Manufacture Practice" and related documents, if any.
b)
Request for trial production conditions for the establishment registering for
the first examination:
The
production establishment must have at least 03 lots of products on the line registered
for examination to appraise the production process and related issues such as
performance evaluation of production equipment, auxiliary facilities, evaluate sanitation
process; assess the capacity and the compatibility of activities of
preservation, testing of drugs for the line registered for examination. These
contents must be fully reflected in the profiles of lots of products and the concerned
records and documents."
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3.
Examination and issuance of certificate
3.1
Competence to appraise dossier, examination, issuance of certificate and
standards of the examiners:
a)
Competence:
-
Drug Administration is responsible for receiving and appraising dossiers of
registration, establishing the examination team, organizing the examination in reality
at the establishments and issuing certificates meeting the principles of
"Good Manufacture Practice" for the establishments after the
examination meeting requirement of GMP.
*
Standards of the examiners:
-
Those who have university degrees or higher, as the pharmacists of university,
or the chemical engineers or microorganism engineers with experience in
production and/or examination/management of drug quality and drug management.
-
Have good health, not getting infectious diseases.
-
Have knowledge and experience in GMP examination: thoroughly grasp the
principles, standards of GMP, have been trained on GMP and inspection,
examination of GMP.
-
Have determined and scientific methods of inspection and examination,
determination; with the ability to rapidly detect errors of the establishments
at the same time take the persuasive measures to help the establishments to
overcome the shortcomings.
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3.2.
The order and procedures for receiving and appraising dossiers, examination,
and grant of certificate
a)
Appraisal of dossiers and organization of examination
-
After receipt of the registration dossier for examination of the establishment
as stipulated in point 1 Section 2 of this Part, the Drug Administration
conducts the appraisal of dossier (with minute of appraisal).
-
Within 05 working days after receipt of dossier and appraisal fees as
prescribed, the management agency must inform in writing the establishment on
the status of dossier if it does not meet the requirements or the examination
plan.
-
Within 20 working days from the date of notification of the examination plan,
the management agency must conduct real examination at the establishment.
-
The establishments registering for examination must report by the diagrams,
chart, and brief data on the operation, the application of principles,
standards of "Good Manufacture Practice".
- Upon examination of GMP, the activities of the establishment must
being conducted.
-
The examination minute must be specifed the existence in the application of
principles of "Good Manufacture Practice" at the the establishment.
In case of disagreement with the opinions of examination team, the minute must
be specified all of the reserved comments of the establishment. The minute
shall be signed by manager of the establishment and the head of the examination
team; made into 03 copies: 01 copy stored at the establishment, 02 copies kept
at the Drug Administration.
*
Handling of examination results and issuance of certificates:
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-
Case 2: For the examined establishment meets basically the principles,
standards of GMP-WHO, and there are still some existence which do not affect
the stored drugs quality and can be overcome in a short term, the examination
team will require the establishment to report the recovery and repair.
The
establishment must fix, repair, and report the results of overcoming the
existence that examination team has raised in the minute submitted to the Drug
Administration.
The
head of examination team synthesizes, reports to the Director for considering
issuing certificate reaching the principles, standards of "Good Manufacture
Practice" or the Drug Administration has to announce the official results
to the establishment within 05 working days after receipt of the report of
overcoming.
Over
02 months after the end of the examination, if the establishment fails to send
regular report of overcoming, it must conduct filing registration for
examination from the beginning.
-
Case 3: For the establishments not meeting the principles, standards of GMP-WHO,
the establishment must conduct overcome, repair existence. After self-examining,
assessing meeting the requirements, the establishments conduct to file
registration for examination from the beginning.
Registration
for reexamination
-
Once every 03 years, 02 months before the certificate of meeting the
principles, standards of "Good Manufacture Practice" expires, the
establishment shall apply for registration of reexamination, except for
irregular cases required by the establishment or the Ministry of health (Drug
Administration).
-
After the establishment filed dossier for registration of reexamination, it is
still allowed to produce drug under the extent specified in the certificate of
"Good Manufacture Practice” and the certificate of eligibility for drug
trading (being valid).
-
During the examination, if it is detected that the establishment has existence
at the level to seriously affect the quality of one or more of drugs, head of
the examination team makes minute, reports to the competent persons for making
decision on formal handling.".
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4. Certificate achieving the principles, standards of
"Good Manufacture Practice" is valid for 03 years from the date of
signing. The certificates which are issued previously with effective term of 02
years are continued to extend their operating time for 01 years from the
expiration date. The Drug Administration issues the decision to extend together
with the list of establishments to be extended in the certificates of achieving
the principles, standards of "Good Manufacture Practice."
Article 5. To amend and supplement Circular No.13/2009/TT-BYT
on 01/9/2009 the Ministry of Health guiding the operation of drug advertising
and information as follows:
1.
To amend and supplement Clause 1 of Article 4 as follows:
"1.
Units registering information and advertising drugs as prescribed in this
Circular shall pay fees appraisal of dossier as prescribed by current law when
filing dossiers registering information, and advertising drugs at the dossiers receiving
agency."
2.
To annul the points b and d, Clause 1, Article 28.
3.
To amend clause 4 of Article 28 as follows:
"4.
Card of drug demonstrator is valid for 05 years from the date of issuance. If wishing
for being re-issued card of drug demonstrator, the units must resubmit their dossiers
01 month before the card expires."
4.
To annul Point b, Clause 1, Article 29.
5.
To amend Clause 1 of Article 30 as follows:
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6.
To amend Form 1a-QC: Form 1a-QC Appendix 4.
7.
To amend Form 2a-QC: Form 2a-QC Appendix 4.
Article 6. To amend and supplement some Articles of
Circular No.22/2009/TT-BYT on 24/11/2009 of the Ministry of Health regulating
on drug registration as follows:
1.
To amend and supplement Point c and d, Clause 4 of Article 10 as follows:
"c)
Drug labels: 02 sets of labels of design. These labels are mounted on A4 paper
stamped by the registration establishment or production establishment. Upon
conducting the re-registration, it shall not require to hand in the label if
there is no change compared to the first registration".
"d) Product Information: Manuals
or information for patients, Summary of product characteristics as prescribed
for each respective type of drug stamped by the registration establishment or
production establishment. Upon conducting the re-registration, it shall not
require to hand in information of products if there is no change compared to
the first registration".
2.
To amend and supplement Point d and đ, Clause 6, Article 10 as follows:
"d)
Certificate of achieving standards of Good Manufacture Practice (GMP-WHO) (not
applicable to the domestic drug production establishment), ISO or other
certificate of equivalent standard must be issued by the competent agencies of
the country of origin, certified name and address of the manufacturer.
đ)
Certificate of eligibility for trading the registration establishment's drug may
be original or copy self-certified by the enterprise (in case register establishment
is different from production establishment)".
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4.
To amend Point b, Clause 3 of Article 17 as follows:
"b)
Part II. Quality dossier: In case dossier of first registration made under the set
of common technical dossier ACTD, when making re-registration, it is only required to
submit standards and methods for testing the finished products."
5.
To amend and supplement Clause 5 and Clause 8 of Article 18 as follows:
"5.
It is certificate of eligibility for trading drug if they are the establishments
trading Vietnam's drug"
"8.
It is certificate of GMP of the medicine production establishment abroad if the
establishments of drug registration hand in FSC or CPP without certification of
the production establishments obtaining GMP standards. Where there are several
establishments engaged in the production of drugs, drug registration establishments
hand in GMP certificates of all manufacturing establishments involved in the production
of finished products."
Article 7. To amend and supplement some Articles of
Circular No.47/2010/TT-BYT on 29/12/2010 of the Ministry of Health guiding the
export and import of drugs and packaging in contact directly with drugs as follows:
1.
To amend and supplement Point e, Clause 2 of Article 4 of Circular No.47/2010/TT-BYT
as follows:
"e)
Drugs of aid, humanitarian aid, rare drugs, and drugs for the treatment needs
of the hospitals are expiry date of 24 months or more, the remaining use
duration of the drug must remain at least 12 months from the date of arriving Vietnam's ports. Where drugs are use duration of less than 24 months, the remaining use
duration of the drug must remain at least one third of expiry date of drug from
the date of arriving Vietnam's ports;"
2.
To amend clause 2 of Article 12 as follows:
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3.
To supplement point đ Clause 1 of Article 17 as follows:
"đ)
The quantity to be imported must conform to the scale of production, research, testing,
and calibration. In case after trial production, imported raw materials are surplus
that the company wishes to put into production of drugs granted the
registration number, it must be reported to the Drug Administration of the
number of existence and expiry date, status of quality and permit for being
used to produce finished products."
4.
To supplement point e, Clause 1 of Article 17 as follows:
"e)
Copy of certificate of satisfaction of conditions trading drugs with the stamp
of the enterprise in case of the first request for importing drugs as sample."
5.
To amend Form No.13a, 13b: Form No.13a,
13b of Appendix 5.
6.
To amend Point b, Clause 1 of Article 22 as follows:
"b)
Written permission of import documents of the competent authorities of the importing
country (originals, copies or Vietnamese translations meeting the provisions of
Item 1, 2 and 3 Point a, Clause 11, Article 4 of the Circular No.47/2010/TT-BYT
number). "
7.
To annul Point d, Clause 1, Article 22.
Article 8. Effect
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During
execution, if any difficulties arise, the units should promptly reflect to the
Drug Administration - Ministry of Health for study to amend and supplement properly./.
FOR MINISTER
DEPUTY MINISTER
Cao Minh Quang
APPENDIX 1
FORM NO.: 01/GLP:
Application for examination of GLP
Name of the governing unit
Name of the unit
--------
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
----------------
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…, date .... month ..... year .....
APPLICATION FOR EXAMINATION OF “GOOD LABORATORY PRACTICE”
To: The Drug
Administration - Ministry of Health
1
- Name of establishment:
2
- Address (head office and laboratories)
3
- Phone: Fax: E-Mail:
4
- The decision to establish (or business registration certificate or investment
certificate) No.............. issued by ..................
To
implement the Decision No.1570/2000/QD-BYT dated 05/22/2000 of Minister of
Health on the implementation to apply principles and standards of "Good Laboratory
Practice" after conducting self-inspection, we register with the Ministry
of Health (drug Administration) to be examined "Good Laboratory Practice"
at any time and commit to promptly remedy the existences listed in the
examination minute.
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(1)
- Copy of establishment license or business registration certificate or
investment certificate certified by the establishment;
(2)
– Organization diagram and staffing of the establishment;
(3)
– Location diagram and design of the laboratory;
(4)
- Analysis equipment list of the establishment;
(5)
- The list of tests (methods) and/or the products that are tested quality by
the establishment./.
Manager of the unit
(Signature and stamp)
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FORM NO.: 02/GLP:
Application for reexamination of GLP
Name of the governing unit
Name of the unit
--------
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
----------------
…, date .... month ..... year .....
APPLICATION FOR REEXAMINATION OF “GOOD LABORATORY PRACTICE”
To: The Drug Administration - Ministry of Health
1
- Name of establishment:
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
3
- Phone: Fax: E-Mail:
4
- The decision to establish (or business registration certificate or investment
certificate) No.............. issued by ..................
To
implement the Decision No.1570/2000/QD-BYT dated 05/22/2000 of Minister of
Health on the implementation to apply principles and standards of "Good
Laboratory Practice" after conducting self-inspection, we register with
the Ministry of Health (drug Administration) to be reexamined "Good
Laboratory Practice" at any time and commit to promptly remedy the
existences listed in the examination minute.
We
enclose with this registration the following related documents:
(1)
- Copy of establishment license or business registration certificate or
investment certificate certified by the establishment;
(2)
- Reports of overcoming the existences at the previous examination;
(3)
- Reports of changes of the establishment within03 years of deployment./.
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
(Signature and stamp)
APPENDIX 2
FORM NO.: 01/GSP:
Application for examination of GSP
Name of the governing unit
Name of the unit
--------
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
----------------
…, date .... month ..... year .....
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
To:
…………………………………………..
1
- Name of establishment:
2
- Address (head office and stores)
3
- Phone: Fax: E-Mail:
4
- The decision to establish (or business registration certificate or investment
certificate) No.............. issued by ..................
To
implement the Decision No…./2001/QD-BYT date …month… 2001 of Minister of Health
on the implementation to apply principles and standards of "Good Storage
Practice" after conducting self-inspection, we register with …to be
examined "Good Storage Practice" and commit to promptly remedy the
existences listed in the examination minute.
We
enclose with this registration the following related documents:
(1)
Data, programs, and summary reports of training, retraining "Good Storage
Practice" at the establishment;
(2)
A copy of establishment license or business registration certificate or
investment certificate signed by the owner of the establishment and stamped for
certification by the establishment;
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(4)
A Diagram of location and design of the store;
(5)
A Storage equipment list of the establishment;
(6)
A list of objects stored and storage conditions, respectively./.
Manager of the unit
(Signature, full name and stamp)
FORM NO.: 02/GSP:
Application for reexamination of GSP
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
----------------
…, date .... month ..... year .....
APPLICATION FOR REEXAMINATION OF “GOOD STORAGE PRACTICE”
To:
…………………………………………..
1
- Name of establishment:
2
- Address (head office and stores)
3
- Phone: Fax: E-Mail:
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
To
implement the Decision No…./2001/QD-BYT date …month… 2001 of Minister of Health
on the implementation to apply principles and standards of "Good Storage
Practice" after conducting self-inspection, we register with …to be
examined "Good Storage Practice" and commit to promptly remedy the
existences listed in the examination minute.
We
enclose with this registration the following related documents:
(1)
A copy of establishment license or business registration certificate or
investment certificate signed by the owner of the establishment and stamped for
certification by the establishment;
(2)
- Reports of overcoming the existences at the previous examination;
(3)
- Reports of changes of the establishment within 03 years of deployment./.
Manager of the unit
(Signature, full name and stamp)
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APPENDIX 3
FORM NO.: 01/GMP:
Application for examination of GMP
Name of the governing unit
Name of the unit
--------
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
----------------
…, date .... month ..... year .....
APPLICATION FOR EXAMINATION OF “GOOD MANUFACTURE PRACTICE”
To: The Drug
Administration - Ministry of Health
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
2
- Address (head office and factory)
3
- Phone: Fax: E-Mail:
4
- The decision to establish (or business registration certificate or investment
certificate) No.............. issued by ..................
To
implement the Decision No.3886/2004/QD-BYT dated 03/11/2004 of Minister of
Health on the implementation to apply principles and standards of "Good
Manufacture Practice" as recommended by the Health Organization World,
after conducting self-inspection and assessment of achieving principles and
standards of "Good Manufacture Practice", we register with the
Ministry of Health (drug Administration) to be examined GMP-WHO for the
lines of producing drugs.
We
enclose with this registration the following related documents:
(1)
- Copy of establishment license or business registration certificate or
investment certificate, certified by the establishment;
(2)
– Organization chart and personnel of the facility;
(3)
- Data, programs, and summary reports of training, retraining "Good
Manufacture Practice" at the establishment;
(4)
- Map of location and design of the factory;
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Manager of the unit
(Signature, full name and stamp)
FORM NO.: 02/GMP:
Application for reexamination of GMP
Name of the governing unit
Name of the unit
--------
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
----------------
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
APPLICATION FOR REEXAMINATION OF “GOOD MANUFACTURE PRACTICE”
To: The Drug
Administration - Ministry of Health
1
- Name of establishment:
2
- Address (head office and factory)
3
- Phone: Fax: E-Mail:
4
- The decision to establish (or business registration certificate or investment
certificate) No.............. issued by ..................
To
implement the Decision No.3886/2004/QD-BYT dated 03/11/2004 of Minister of
Health on the implementation to apply principles and standards of "Good
Manufacture Practice" as recommended by the Health Organization World,
after conducting self-inspection and assessment of achieving principles and
standards of "Good Manufacture Practice", we register with the
Ministry of Health (drug Administration) to be examined GMP-WHO for the
lines of producing drugs:………..(state clearly the new lines registered for
additional examination, if any)…
We
enclose with this registration the following related documents:
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(2)
- Reports of overcoming the existences at the previous examination;
(3)
- Summary Report of the activities of the establishment for the past 03 years;
(4)
- Reports of changes of the establishment within 03 years of deployment of the
"Good Manufacture Practice" and related documents, if any.
……….., date month
year
Manager of the
unit/Unit’s owner
(Signture, full name and stamp)
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Form 1a-QC: Application for grant card of drug demonstrator
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
--------------------------
APPLICTION FOR GRANT CARD OF DRUG DEMONSTRATOR
To: Department of
health of province (city).......
1. Name of the unit assigning
the drug demonstrator:
2. Address:
3. Phone number, Fax, E-mail :
4. Number of operation license of the unit:
5. List of persons who are requested for issuing
card: the
drug demonstrators
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Full name
Date/month/ year of birth
Qualification
Address of residence
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7.
Unit includes this application:
-
Copies of diplomas or professional certificates
-
List of items assigned to introduce of each person
-
A written commitment of persons employed, assigned for introducing drugs that
they thorough grasped and comply with the legal documents of the relevant
drug.
-
Certificate of training of the drugs demonstrators issued by the training
establishment as prescribed by the Health Ministry.
-
Certification of operation duration for at least two years in the legal medical
pharmaceutical establishments.
Date month year
...
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(Signature and stamp)
State clearly full name of
signer
Form 2a-QC: Application
for dossiers of seminars for drugs introduction
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
--------------------------
APPLICATION FOR DOSSIERS OF SEMINARS FOR DRUGS
INTRODUCTION
No. :..................................
To: Department of health of province
(city)...........
1.
Unit’s name registering dossiers:
...
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3.
Phone Number, Fax, E-mail:
4.
Number of operation licenses:
5.
Full name, phone number of person or division being in charge of registering dossiers:
6.
List of registered drugs for seminars for medical officials:
Names of drugs
Registration No.
Objects to ettend the seminar
The time
1
...
...
...
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2
3
...
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...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
7.
Location and time estimated to hold the seminar:
8.
Commitment of the unit holding the seminar:
We
have researched carefully the Circular guiding the operation of information,
advertisement of drugs of the Minister of Health issued on ... and commit to comply
with the provisions of the Circular for sack of health and interests of patients.
Name of province/city,
Date month year
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
(State clearly title)
(Signature and stamp)
State clearly full name of
signer
APPENDIX 5
NAME OF EXPORTER
No.: …………….......
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
-------------------------
APPLICATION FOR
EXPORTING DRUGS CAUSING ADDICTION (PSYCHOTROPICS DRUG OR PRE-SUBSTANCES USED AS
DRUGS)
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Name
of exporter (including abbreviated name, Vietnamese
name, English name):................................................................................
Address (Vietnamese, English):................................................................................................................................................................
No.
Drug names, concentration, dosage form, packing
The active ingredient
Unit
Registration No. (if any)
Quantity
Name drugs causing addiction (psychotropic drugs or
pre-substances used as drugs) - Content in a unit divided doses or not
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Name and address of manufacturer - Countries
Name, address of exporter -countries
1
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
2
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...
...
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TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Border gate intended to export goods (stating clearly name
of the airport, port):
(**) Enterprise hereby complies with export contracts
and not to circulate the products that have not been granted registration
numbers for circulation in Vietnam and the products with sample of label
produced for export.
Note: (*) Name and address of the company
manufacturing, importing company must be fully detailed.
(**) For requesting for exporting drugs having not been
granted registration numbers for circulation
Recipient:
- The Drug Administration - Ministry of
Health
- Archived at the unit
(Full name, Signature, stamp)
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
NAME OF EXPORTER
No.: …………….......
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
-------------------------
APPLICATION FOR
EXPORTING DRUGS CAUSING ADDICTION (PSYCHOTROPICS DRUG OR PRE-SUBSTANCES USED AS
DRUGS)
under form of
coordination
To: The Drug Administration - Ministry of Health
Name
of exporter (including abbreviated name, Vietnamese
name, English name):................................................................................
Address (Vietnamese, English):................................................................................................................................................................
No.
...
...
...
Bạn phải
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TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
The active ingredient
Unit
Quantity
Name the active ingredient causing addiction (psychotropic
the active ingredient or pre-substances used as drugs) - Content in a unit
divided doses or not
Total volume of active ingredient causing addiction (or
psychotropic the active ingredient or pre-substances used as drugs) into gram
Name and address of manufacturer - Countries (*) (*)
Name and address of importer - Countries
1
...
...
...
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TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
2
...
...
...
Bạn phải
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TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Border gate intended to export goods (stating clearly
name of the airport, port):
(**) Enterprise hereby complies with export contracts
and not to circulate the products that have not been granted registration
numbers for circulation in Vietnam and the products with sample of label
produced for export.
Note:
(*) Name and address of the company manufacturing,
importing company must be fully detailed.
(**) For requesting for exporting drugs having not
been granted registration numbers for circulation
...
...
...
Bạn phải
đăng nhập hoặc
đăng ký Thành Viên
TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Recipient:
- The Drug Administration - Ministry of
Health
- Archived at the unit
(Full name, Signature, stamp)