CIRCULAR

AMENDING AND SUPPLEMENTING A NUMBER OF ARTICLES OF DECISION NO.1570/2000/QD-BYT DATED 22/05/2000 OF MINISTER OF THE 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

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."

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

As production establishments issued certificate of "Good Manufacture Practice (GMP)" by the Drug Administration in accordance with the intention of producing and processing drugs. Where drug received for processing is oriental medicines or drugs derived from medicine, the establishments taking outsource to produce drug must comply with the Health Ministry s regulations on the schedule achieving standard of GMP."

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

No.3886/2004/QD-BYT dated 13/11/2004 the Ministry of Health on the deployment of application of the principle and standards of "Good Manufacture Practices" as recommended by the World Health Organization as follows:

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.

(5) Diagram of location and design of the factory, including the diagram of general plan; path diagram of the workers; path diagram of raw materials, packaging, semi-finished and finished products; diagram of water supply systems for production; gas supply diagram for the factory; diagram showing the levels of cleanliness of the factory; waste disposal diagram.

(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."

2. To amend and supplement Clause 3 of Section II as follows:

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.

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

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:

-Case 1: If the examined establishment meets the principles, standards of GMP-WHO, the Drug Administration shall issue a certificate of achieving the principles, standards of "Good Manufacture Practice" within 05 working days from the end of the examination.

-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 ofGMP-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.".

3. To amend Form No.01/GMP Form No.02/GMP Decision No.3886/2004/QD-BYT:Form No.01/GMP, No.02/GMP (Appendix 3).

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:

"1. Before the units inform, advertise drugs, it must submit 01 set of dossier to register information and advertise drugs to the Ministry of Health (Drug Administration)."

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)".

3. To annul Point e, Clause 6, Article 10.

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 dossierACTD, 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:

"2. Enterprises send applications to the Drug Administration-Ministry of Health. Within 07 working days from receipt of valid dossiers, Drug Administration, Ministry of Health shall consider for grant of import permits. In case of refusal, Drug Administration-Ministry of Health has to send written replies, clearly stating the reasons therefore."

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

This Circular takes effect from February 05, 2012. The previous regulations contrary to the provisions in this Circular are hereby annulled.

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./.

APPENDIX 1

FORM NO.: 01/GLP: Application for examination of GLP

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./.

FORM NO.: 02/GLP: Application for reexamination of GLP

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./.

APPENDIX 2

FORM NO.: 01/GSP: Application for examination of GSP

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./.

FORM NO.: 02/GSP: Application for reexamination of GSP

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./.

APPENDIX 3

FORM NO.: 01/GMP: Application for examination of GMP

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.

FORM NO.: 02/GMP: Application for reexamination of GMP

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.

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

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 graspedand 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.

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:

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.

APPENDIX 5

Form No. 13a

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):................................................................................................................................................................

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

Form No. 13b

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):................................................................................................................................................................

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