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

2.2.1. Registration for the first examination:

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:

(1) A written registration for re-examination "Good Laboratory Practice" (Form 02/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) 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:

- 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.

- 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.

- The establishments registering for examination of "Good Laboratory Practice" must report by the diagrams, diagrams and brief data on the operation, the application of principles of "Good Laboratory Practice".

- 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

- 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 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:

(1) A registration application for examination "Good Storage Practice" (Form 01/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;

(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;

(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 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.

- Honest, objective and strictly abide by regulations and provisions of laws in the exmination process.

- 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.

* Handling of examination results and issuance of certificates:

- 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.

- After the establishment filed dossier for registration of reexamination, it is still allowed to store drug under the extent specified in the certificate of "Good Storage 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 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."

For further information, visit here

 

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 ----------------
	…, 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.

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 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)

 

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:

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 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./.

 

Manager of the unit (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 .....

 

APPLICATION FOR EXAMINATION OF “GOOD STORAGE PRACTICE”

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;

(3) A Organization diagram of the establishment;

(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

Name of the governing unit Name of the unit --------	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:

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) 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)

 

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

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.

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;

(5) - List of existence equipment of the factory.

 

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 ----------------
	…, date .... month ..... year .....

 

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:

(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) - 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)

 

APPENDIX 4

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

No.	Full name	Date/month/ year of birth	Qualification	Address of residence

6. Unit (name of application unit) commits that it held and shall hold the training classes, train regularly for the drugs demonstrators (1) The knowledge of the drugs they will cover and (2) The concerned professional regulations.

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 Head of the Unit (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:

2. Address:

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:

No.	Names of drugs	Registration No.	Objects to ettend the seminar	The time
1
2
3

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 Head of the Unit (State clearly title) (Signature and stamp) State clearly full name of signer

 

APPENDIX 5

Form No. 13a

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)

To: The Drug Administration - Ministry of Health

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	Total volume of drugs causing addiction (or psychotropic drugs or pre-substances used as drugs) into gram	Name and address of manufacturer - Countries	Name, address of exporter -countries
1
2

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

..... Date... month... year.... Director of exporter (Full name, Signature, stamp)