CIRCULAR

Amending and supplementing certain provisions of Decision No. 1570/2000/QĐ-BYT dated May 22, 2000 of the Minister of Health on the implementation of the principle of "Good Laboratory Practice for Pharmaceutical Testing"; Decision No. 2701/2001/QĐ-BYT

dated June 29, 2001 of the Minister of Health on the implementation of the principle of "Good Storage Practice for Medicines"; Circular No. 06/2004/TT-BYT dated May 28, 2004 guiding the production and processing of medicines; Decision No. 3886/2004/QĐ-BYT dated November 13, 2004 of the Ministry of Health on the implementation of the principles and standards of "Good Manufacturing Practice for Medicines" as recommended by the World Health Organization; Circular No. 13/2009/TT-BYT dated September 1, 2009 of the Ministry of Health guiding the activities of drug advertising information; Circular No. 22/2009/TT-BYT dated November 24, 2009 of the Ministry of Health stipulating the registration of drugs; Circular No. 47/2010/TT-BYT dated December 29, 2010 guiding the activities of exporting and importing drugs and packaging that comes into direct contact with drugs Pursuant to Decree No. 188/2007/NĐ-CP dated December 27, 2007 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

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Pursuant to the Medicine Law No. 34/2005/QH11 dated June 14, 2005;

The Ministry of Health guides the implementation and application of the principles and standards of "Good Laboratory Practice for Pharmaceutical Testing", "Good Storage Practice for Medicines", "Good Manufacturing Practice for Medicines", guiding the production and processing of medicines, drug advertising information, guiding the activities of exporting and importing drugs and packaging that comes into direct contact with drugs, and the regulations on drug registration as follows:

Article 1. Amending and supplementing certain provisions of Decision No. 1570/2000/QĐ-BYT dated May 22, 2000 of the Minister of Health on the implementation of the principle of "Good Laboratory Practice for Pharmaceutical Testing" as follows:

1. Amending and supplementing Point 2.2 Clause 2 Part III as follows:

“2.2. Inspection and issuance of certificate

2.2.1. Registration for inspection:

After self-inspection and evaluation to meet the principle of "Good Laboratory Practice for Pharmaceutical Testing", the facilities shall submit one set of registration files for inspection to the Department of Drug Management - Ministry of Health. The registration file includes:

- In case of initial inspection registration:

(1) The registration form for "Good Laboratory Practice for Pharmaceutical Testing" (Model 01/GLP Appendix No. 1);

(2) A copy of the establishment permit of the facility or business registration certificate or investment certificate signed by the facility's owner and stamped with the facility's confirmation seal;

(3) Organizational chart and staffing of the facility;

(4) Geographic location map and design of the testing laboratory;

(5) List of analytical equipment of the facility;

(6) List of test methods (procedures) and/or products for quality control testing conducted by the facility;

- In case of re-inspection registration:

(1) The re-inspection registration form for "Good Laboratory Practice for Pharmaceutical Testing" (Model 02/GLP Appendix No. 1);

(3) Report on rectifying deficiencies from the previous inspection;

(3) Organizational chart and staffing of the facility;

(4) Report on changes in the facility during the three years of implementing "Good Laboratory Practice for Pharmaceutical Testing" and related documentation, if any.

2.2.2. Inspection and issuance of certificate

a) Authority to review applications, conduct inspections, issue certificates, and qualifications of inspectors:

* Authority:

- The Ministry of Health issues a decision to establish an inspection team and issue a certificate of compliance with the principle of "Good Laboratory Practice for Pharmaceutical Testing" for the Central Institute for Pharmaceutical Testing, Ho Chi Minh City Institute for Pharmaceutical Testing, and National Institute for Vaccine and Biological Product Control.

- The Department of Drug Management issues a decision to establish an inspection team and issue a certificate of compliance with the principle of "Good Laboratory Practice for Pharmaceutical Testing" for provincial pharmaceutical and cosmetic testing centers under central cities, enterprise testing facilities, independent laboratories, or private laboratories.

* Qualifications of inspectors:

- Hold a bachelor's degree or higher, with experience in general drug management and specific quality control testing of medicines.

- Possess scientific inspection and audit methods, be resolute, and have the ability to quickly identify deficiencies in facilities and propose convincing measures to help them correct these deficiencies.

- Be honest, impartial, and strictly comply with all regulations and laws during the inspection process.

- Be in good health and not suffer from infectious diseases.

b) Reviewing applications and organizing inspections

- After receiving the inspection registration file of the facility according to Point 2.2.1 of this section, the Department of Drug Management will conduct a review of the file (with a review record).

- Within five working days from the date of receipt of the file and the inspection fee as prescribed, the managing authority must notify the facility about the status of the file if it does not meet the requirements or the inspection plan.

- Within twenty working days from the date of notification of the inspection plan, the managing authority must conduct an actual inspection at the facility.

c) Conducting inspections, handling inspection results, and issuing certificates

* Inspections

- The inspection team is responsible for inspecting all activities of the facility according to the principles of "Good Laboratory Practice for Pharmaceutical Testing" and current professional regulations.

- Facilities registering for "Good Laboratory Practice for Pharmaceutical Testing" inspections must report their operational situation and the implementation of the "Good Laboratory Practice for Pharmaceutical Testing" principle through diagrams, charts, and concise data.

- The inspection record must clearly indicate any deficiencies in the implementation of the "Good Laboratory Practice for Pharmaceutical Testing" principle at the facility. In cases where there is disagreement with the inspection team's opinion, the record must clearly state all reservations of the facility. The record must be signed and confirmed by the facility manager and the inspection team leader; three copies are made: one copy kept by the facility, two copies kept by the Department of Drug Management.

* Handling inspection results and issuing certificates:

If the inspected facility meets the principles of "Good Laboratory Practice for Pharmaceutical Testing", the competent authority as stipulated in Subpoint a of Point 2.2.2 of this section shall issue a certificate of compliance with the principle of "Good Laboratory Practice for Pharmaceutical Testing" within five working days from the end of the inspection.

- Case 1:Case 2:

- Case 2:For facilities that are basically in compliance with the "Good Practice for Drug Storage" principle but have some remaining issues that do not affect the quality of stored drugs and can be rectified within a short period, the Inspection Team will require the facility to report on corrective actions and repairs.

The facility must rectify and repair the identified issues and report the results of such corrections in the inspection record sent back to the Drug Management Department.

The Head of the Inspection Team will compile and report to the authority for consideration to issue a Certificate of Compliance with the "Good Practice for Drug Storage" principle, or the competent management authority must officially notify the facility of the result within five working days from the date of receipt of the correction report.

If the facility does not submit a valid correction report within two months from the end of the inspection, it must resubmit the application for inspection from the beginning.

- Case 3:For facilities that do not meet the "Good Practice for Drug Storage" principle, the facility must undertake corrective measures. After self-inspection and evaluation show compliance, the facility must resubmit the application from the beginning.

* Re-registration Application

- The Certificate of Compliance with the "Good Practice for Drug Storage" principle is valid for three years from the date of issuance.

- Annually once every three years, before the Certificate of Compliance with the "Good Practice for Drug Storage" principle expires by two months, the facility must submit an application for re-registration, except in cases of emergency requested by the facility or the Ministry of Health (Drug Management Department).

- After submitting the re-registration application, the facility may continue to conduct drug testing within the scope specified in the "Good Practice for Drug Testing Laboratory" and the Pharmaceutical Business Conditions Certificate (still valid).

During the inspection process, if serious issues affecting the quality of drug testing or the operation of the facility are discovered, the team leader will prepare a record and report to the authority for formal action.

2. Amend and supplement the sample form for registering "Good Practice for Drug Storage" at Section E Part IV: Form No. 01/GLP, Appendix 1.

Article 2. Amend and supplement certain provisions of Decision No. 2701/2001/QĐ-BYT dated June 29, 2001, of the Minister of Health regarding the implementation of the "Good Practice for Drug Storage" principle as follows:

1. Amend and supplement Clause 2.2 Section 2 Part III as follows:

“2.2. Registration for Inspection:

After self-inspection and evaluation showing compliance with the "Good Practice for Drug Storage" principle, facilities shall submit one set of registration application documents to the authorized agency as stipulated in Point 2.3.1 of this section. The registration application includes:

(1) The registration form for "Good Laboratory Practice for Pharmaceutical Testing" (Model 01/GLP Appendix No. 1);

(1) The "Good Practice for Drug Storage" inspection registration form (Form 01/GSP, Appendix 2);

(2) A copy of the establishment permit or business registration certificate or investment certificate signed by the facility owner and stamped with the facility's confirmation seal;

(3) Training and education materials, programs, and summary reports on "Good Practice for Drug Storage" at the facility;

(4) Organizational chart of the facility;

(5) Geographic layout and design of the warehouse;

(6) List of storage equipment of the facility;

(7) List of items stored and corresponding storage conditions.

(1) The re-inspection registration form for "Good Laboratory Practice for Pharmaceutical Testing" (Model 02/GLP Appendix No. 1);

(1) The "Good Practice for Drug Storage" re-registration form (Model 02/GSP, Appendix 2);

(2) A copy of the establishment permit or business registration certificate or investment certificate signed by the facility owner and stamped with the facility's confirmation seal;

(4) Report on changes in the facility during the three years of implementing "Good Laboratory Practice for Pharmaceutical Testing" and related documentation, if any.

(4) Report on changes in the facility over the past three years implementing "Good Practice for Drug Storage" and related documentation, if applicable.

2.3. Authority to review applications, inspect, issue certificates, and standards for inspectors:

2.3.1. Authority:

a) The Drug Management Department is responsible for receiving and reviewing registration applications, forming inspection teams, conducting on-site inspections at facilities, and issuing Certificates of Compliance with the "Good Practice for Drug Storage" principle for facilities providing drug storage services.

b) Provincial or municipal health departments where the storage facility is located are responsible for receiving and reviewing registration applications, forming inspection teams, conducting on-site inspections at facilities, and issuing Certificates of Compliance with the "Good Practice for Drug Storage" principle for other cases.

2.3.2. Standards for Inspectors:

- Personnel with a bachelor's degree or higher, with experience in pharmaceutical management generally and specifically in drug storage.

- Be honest, impartial, and strictly comply with all regulations and laws during the inspection process.

- Be in good health and not suffer from infectious diseases.

b) Reviewing applications and organizing inspections

2.4. Reviewing Applications and Conducting Inspections

- After receiving the registration application from the facility according to Clause 2.2 of this section, the authorized management agency as stipulated in Point 2.3.1 of this section will review the application (with a review record).

- Within twenty working days from the date of notification of the inspection plan, the managing authority must conduct an actual inspection at the facility.

c) Conducting inspections, handling inspection results, and issuing certificates

2.5. Inspection, Handling Inspection Results, and Issuing Certificates

- The inspection team is responsible for inspecting all activities of the facility according to the principles of "Good Laboratory Practice for Pharmaceutical Testing" and current professional regulations.

- The inspection team is responsible for inspecting all activities of the facility according to the "Good Practice for Drug Storage" principles and current professional regulations.

- Facilities applying for inspection of "Good Practice for Drug Storage" must report on their operations and the implementation of the "Good Practice for Drug Storage" principle through diagrams, charts, and concise data.

- The inspection record must clearly identify any issues in the implementation of the "Good Practice for Drug Storage" principle at the facility. In case of disagreement with the inspection team's opinion, all reservations of the facility must be recorded. The record must be signed and confirmed by the facility manager and the head of the inspection team; three copies must be made: one copy retained by the facility, two copies retained by the agency issuing the inspection team formation decision.

If the inspected facility meets the principles of "Good Laboratory Practice for Pharmaceutical Testing", the competent authority as stipulated in Subpoint a of Point 2.2.2 of this section shall issue a certificate of compliance with the principle of "Good Laboratory Practice for Pharmaceutical Testing" within five working days from the end of the inspection.

- Case 1:If the inspected facility complies with the "Good Practice for Drug Storage" principle, the authorized management agency as stipulated in Point 2.3.1 of this section will issue a Certificate of Compliance with the "Good Practice for Drug Storage" principle within five working days from the end of the inspection.

- Case 2:For facilities that are basically in compliance with the "Good Practice for Drug Storage" principle but have some remaining issues that do not affect the quality of stored drugs and can be rectified within a short period, the Inspection Team will require the facility to report on corrective actions and repairs.

The inspected entity must rectify, repair, and report the results of addressing the deficiencies noted by the inspection team in the minutes sent back to the management agency that issued the decision to establish the inspection team.

The Head of the Inspection Team shall compile and report to the authorized person for consideration to issue a Certificate of Compliance with Good Storage Practices for Medicines, or the management agency must officially notify the entity of the result within five working days from the date of receipt of the rectification report.

If the facility does not submit a valid correction report within two months from the end of the inspection, it must resubmit the application for inspection from the beginning.

- Case 3:For entities not meeting the Good Storage Practices for Medicines principle, the entity must carry out rectifications and repairs. After self-inspection and evaluation showing compliance, the entity must resubmit the application from the beginning.

* Re-registration Application

- Annually once every three years, before the Certificate of Good Storage Practices for Medicines expires two months, the entity must submit an application for re-inspection, except in cases of emergencies requested by the entity or the management agency.

- After submitting the application for re-inspection, the entity may continue to store medicines within the scope specified in the Certificate of Good Storage Practices for Medicines and the Certificate of Eligibility for Medicine Business Operations (still valid).

- During the inspection process, if serious deficiencies affecting the quality of stored medicines are discovered, the Head of the Inspection Team shall prepare a record and report to the authorized person to issue a formal decision on handling.

2. Amend Model Number 03-GSP/MB: Model Number 01/GSP and Model Number 02/GSP in Appendix 2.

3. The Certificate of Compliance with the Good Storage Practices for Medicines is valid for three years from the date of issuance. Certificates previously issued by the Drug Administration with a validity period of two years will be extended by one additional year from their expiration date. The Drug Administration shall issue a decision on extension accompanied by a list of entities whose certificates have been extended.

Article 3. Amend and supplement some provisions of Circular No. 06/2004/TT-BYT dated May 28, 2004, of the Ministry of Health guiding the production and processing of medicines as follows:

1. Amend and supplement Point 1.1 Clause 1 Section I as follows:

"1.1. Scope of Application: Organizations, enterprises, and individuals engaged in pharmaceutical production."

2. Repeal Point 1.3 Clause 1 Section II.

3. Amend and supplement Clause 1 Section III as follows:

"1. Conditions for being listed as the Recipient of Processing

Must be a production facility that has been granted a Certificate of Good Manufacturing Practice (GMP) by the Drug Administration, suitable for the planned processing of medicines. In the case of traditional medicine or medicine derived from herbal sources, the processing facility must comply with the regulations set forth by the Ministry of Health regarding the phased achievement of GMP standards."

4. Amend and supplement Point 1.1 Clause 1 Section V as follows:

"1.1. The application for registration of processed medicine production includes one original copy and two copies of the standard and testing methods."

5. Amend and supplement the title of Point 2.1 Clause 2 Section V as follows:

"2.1. Application for Registration of Domestic Production Facilities Requesting Processing of Medicines Already Registered for Circulation in Vietnam:"

6. Add to Point 2.1 Clause 2 Section V as follows:

"2.1. Technical documentation shall be prepared in accordance with Article 19 of Circular No. 22/2009/TT-BYT dated November 24, 2009, of the Ministry of Health guiding the registration of medicines."

7. Add to Point 2.2 Clause 2 Section V as follows:

"2.2. Technical documentation shall be prepared in accordance with Article 19 of Circular No. 22/2009/TT-BYT dated November 24, 2009, of the Ministry of Health guiding the registration of medicines."

Article 4. Amend and supplement some provisions of Decision No. 3886/2004/QĐ-BYT dated November 13, 2004 of the Ministry of Health on implementing and applying the principles and standards of "Good Manufacturing Practice for Medicinal Products" as recommended by the World Health Organization as follows:

1. Amend and supplement Clause 2 of Section II as follows:

“2. Registration procedures for inspection:

a) Registration for inspection:

After self-inspection and evaluation to meet the principles and standards of "Good Manufacturing Practice for Medicinal Products", the facilities shall submit one set of registration dossier for inspection to the Department of Drug Management - Ministry of Health. The registration dossier includes:

(1) The registration form for "Good Laboratory Practice for Pharmaceutical Testing" (Model 01/GLP Appendix No. 1);

(1) Application for inspection of "Good Manufacturing Practice for Medicinal Products" (in accordance with Form 01/GMP in Appendix No. 3);

(2) A copy of the establishment permit or business registration certificate or investment certificate signed by the facility owner and stamped with the facility's confirmation seal;

(3) Organizational chart and personnel list of the facility;

(4) Training and education program and summary report on "Good Manufacturing Practice for Medicinal Products" at the facility;

(5) Layout diagrams of the factory including overall floor plan; worker pathway diagram; raw material, packaging, semi-finished product, finished product pathway diagram; water supply system diagram for production; air supply system diagram for the factory; cleanroom classification diagram; waste treatment diagram.

(6) List of existing equipment in the factory.

(1) The re-inspection registration form for "Good Laboratory Practice for Pharmaceutical Testing" (Model 02/GLP Appendix No. 1);

(1) Application for inspection of "Good Manufacturing Practice for Medicinal Products" (Form 02/GMP in Appendix No. 3);

(2) A copy of the establishment permit or business registration certificate or investment certificate signed by the facility owner and stamped with the facility's confirmation seal;

(4) Report on changes in the facility during the three years of implementing "Good Laboratory Practice for Pharmaceutical Testing" and related documentation, if any.

(4) Summary report on the operation of the facility over the past three years;

(5) Report on changes made by the facility during the past three years of implementing "Good Manufacturing Practice for Medicinal Products" and related documentation, if any.

b) Requirements for trial production for facilities registering for inspection for the first time:

The facility must produce at least three batches of products on the registered production line to assess the production process and related issues such as evaluating the performance of production equipment, auxiliary utilities, cleaning procedures; assessing the capacity and suitability of drug storage, testing activities for the registered production line. These contents must be fully reflected in the batch record and related documents and files.”

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

"3. Inspection and issuance of Certificate

3.1. Authority to review applications, conduct inspections, issue certificates, and qualifications of inspectors:

a) Authority

The Department of Drug Management is responsible for receiving, reviewing registration dossiers for inspection, forming inspection teams, conducting on-site inspections at facilities, and issuing Certificates of Compliance with the principles and standards of "Good Manufacturing Practice for Medicinal Products" to facilities that meet the requirements after inspection.

b) Qualifications of Inspectors:

- Hold a bachelor's degree or higher, be a pharmacist, chemical engineer, or microbiology engineer, with experience in pharmaceutical production and/or quality control/testing and drug management activities.

- Be in good health and not suffering from infectious diseases.

- Have knowledge and experience in GMP inspection: Proficient in GMP principles and standards, trained in GMP and GMP auditing/inspection.

- Be honest, impartial, and strictly comply with all regulations and laws during the inspection process.

- Be in good health and not suffer from infectious diseases.

3.2. Procedures and processes for receiving, reviewing applications, conducting inspections, and issuing certificates

a) Reviewing applications and organizing inspections

- After receiving the registration dossier for inspection from the facility in accordance with point a of Section 2 of this Part, the Department of Drug Management will proceed to review the dossier (with a review report).

- Within five working days from the date of receipt of the dossier and inspection fee as prescribed, the authority must notify the facility in writing about the status of the dossier if it does not meet the requirements or establish an inspection plan.

c) Conducting inspections, handling inspection results, and issuing certificates

b) Conducting inspections, processing inspection results, and issuing certificates

* Inspection:

- The inspection team is responsible for inspecting all activities of the medicinal product manufacturing facility according to GMP-WHO principles and standards and current professional regulations.

- Facilities registering for inspection must prepare reports in the form of diagrams, charts, and concise data on their operational situation and implementation of GMP principles and standards.

- During GMP inspections, the facility's activities must be ongoing.

- The inspection report must clearly identify any shortcomings in the implementation of GMP at the facility. In case of disagreement with the inspection team's opinion, the report must record all reservations of the facility. The report is signed and confirmed by the facility manager and the head of the inspection team; three copies are made: one copy kept at the facility, two copies kept at the Department of Drug Management.

If the inspected facility meets the principles of "Good Laboratory Practice for Pharmaceutical Testing", the competent authority as stipulated in Subpoint a of Point 2.2.2 of this section shall issue a certificate of compliance with the principle of "Good Laboratory Practice for Pharmaceutical Testing" within five working days from the end of the inspection.

- Case 1If the inspected facility meets the GMP-WHO principles and standards, the Department of Drug Management will issue a Certificate of Compliance with the principles and standards of "Good Manufacturing Practice for Medicinal Products" within five working days from the end of the inspection.

- Case 2For facilities that basically meet the GMP-WHO principles and standards but have some shortcomings that do not affect the quality of the drugs and can be corrected in a short period, the inspection team will require the facility to report on corrective actions.

The facility must rectify and repair the identified issues and report the results of such corrections in the inspection record sent back to the Drug Management Department.

The head of the inspection team will compile and report to the Director for consideration to issue a Certificate of Compliance with the principles and standards of "Good Manufacturing Practice for Medicinal Products" or the Department of Drug Management must officially notify the facility of the result within five working days from the date of receipt of the corrective action report.

If the facility does not submit a valid correction report within two months from the end of the inspection, it must resubmit the application for inspection from the beginning.

- Case 3For facilities that do not meet the GMP-WHO principles and standards, the facility must correct and repair the deficiencies. After self-inspection and evaluation to meet the requirements, the facility must resubmit the application from the beginning.

* Re-registration for inspection

- Annually once every three years, before the Certificate of Compliance with the principles and standards of "Good Manufacturing Practice for Medicinal Products" expires by two months, the facility must submit a re-inspection registration dossier, except in cases of emergency requested by the facility or the Ministry of Health (Department of Drug Management).

- The facility may continue to operate within the scope specified in the "Good Manufacturing Practice for Medicinal Products" Certificate and the Drug Business Conditions Certificate (still valid) after submitting the re-inspection registration dossier.

- During the inspection, if serious violations affecting the quality of one or more medicinal products are discovered, the head of the inspection team will prepare a report and report to the authorized person to make a formal decision.

3. Amend Form 01/GMP and Form 02/GMP of Decision No. 3886/2004/QĐ-BYT: Form 01/GMP, Form 02/GMP (Appendix 3).

4. The certificate attesting to compliance with the "Good Manufacturing Practice for Medicines" principles and standards is valid for three years from the date of issuance. Certificates previously issued with a validity period of two years shall be extended for an additional year from the expiration date. The Department of Medicine Management shall issue a decision on extension accompanied by a list of facilities whose certificate validity periods have been extended.

Article 5. Amend and supplement Circular No. 13/2009/TT-BYT dated September 1, 2009, of the Ministry of Health guiding the operation of drug advertising information as follows:

1. Amending and supplementing Clause 1 of Article 4 as follows:

"1. Units registering drug information and advertisements in accordance with this Circular must pay the registration file examination fee as prescribed by current laws when submitting the drug information and advertisement registration file to the receiving agency."

2. Repeal points b and d of Clause 1, Article 28.

3. Amend Clause 4, Article 28 as follows:

"4. The Drug Promoter Card is valid for five years from the date of issuance. If wishing to renew the Drug Promoter Card, the unit must submit the application file one month before the Drug Promoter Card expires."

4. Repeal point b of Clause 1, Article 29.

5. Amend Clause 1, Article 30 as follows:

"1. Units must submit one set of the drug information and advertisement registration file to the Ministry of Health (Department of Medicine Management) prior to disseminating such information and advertisements."

6. Amend Model 1a-QC: Model 1a-QC Appendix 4.

7. Amend Model 2a-QC: Model 2a-QC Appendix 4.

Article 6. Amend and supplement some articles of Circular No. 22/2009/TT-BYT dated November 24, 2009, of the Ministry of Health regarding drug registration as follows:

1. Amend and supplement points c and d of Clause 4, Article 10 as follows:

"c) Drug labels: Two sets of label samples designed. These labels must be attached to A4 paper stamped with the seal of the registration entity or the manufacturing entity. When re-registering, there is no need to resubmit the labels if they remain unchanged from the initial registration."

"d) Product information: The User Guide or Information for Patients, Summary of Product Characteristics according to the regulations applicable to each type of drug, must be stamped with the seal of the registration entity or the manufacturing entity. When re-registering, there is no need to resubmit the product information if it remains unchanged from the initial registration."

2. Amend and supplement points d and đ of Clause 6, Article 10 as follows:

"d) Certificate of compliance with Good Manufacturing Practice for Medicines (GMP-WHO) (not applicable to domestic manufacturing entities), ISO, or equivalent certificates must be issued by the competent authority of the country of origin and confirmed with the name and address of the manufacturer."

"đ) Certificate of eligibility for drug business of the registration entity may be the original or a self-certified copy (in cases where the registration entity is different from the manufacturing entity)."

3. Repeal point e of Clause 6, Article 10.

4. Amend point b of Clause 3, Article 17 as follows:

"b) Part II. Quality File: In cases where the initial registration file has already been prepared according to the Common Technical Document (CTD) format, only the Finished Product Specifications and Test Methods need to be submitted upon re-registration."

5. Amend and supplement Clause 5 and Clause 8, Article 18 as follows:

"5. Certificate of eligibility for drug business if the entity is a Vietnamese drug business entity."

"8. GMP certificate of foreign manufacturing entities if the drug registration entity submits FSC or CPP without confirmation that the manufacturing entity meets GMP standards. In cases where multiple entities participate in the drug production process, the drug registration entity must submit GMP certificates of all participating manufacturing entities involved in producing the finished product."

Article 7. Amend and supplement some articles of Circular No. 47/2010/TT-BYT dated December 29, 2010 of the Ministry of Health guiding the export and import activities of drugs and direct contact drug packaging as follows:

1. Amend and supplement Point e Clause 2 Article 4 of Circular No. 47/2010/TT-BYT as follows:

"e) Donated drugs, humanitarian aid drugs, rare drugs, and hospital-use drugs with an expiration period of 24 months or more must have at least 12 months remaining from the date of arrival at Vietnam's port. In cases where the expiration period is less than 24 months, the remaining expiration period from the date of arrival at Vietnam's port must be at least one-third of the drug’s expiration period;"

2. Amend Clause 2 Article 12 as follows:

"2. Enterprises submit the dossier to the Drug Administration of Vietnam under the Ministry of Health. Within seven working days from the date of receipt of a complete dossier, the Drug Administration of Vietnam under the Ministry of Health shall examine and issue an import permit. If the permit is not issued, the Drug Administration of Vietnam under the Ministry of Health shall notify the enterprise in writing and specify the reasons."

3. Supplement Point d Clause 1 Article 17 as follows:

"d) The quantity requested for import must be appropriate to the scale of production, research, testing, and inspection. In cases where surplus raw materials remain after trial production and the company wishes to incorporate them into the production of registered drugs, the company must report to the Drug Administration the quantity on hand, expiration date, quality status, and request permission to use them for finished drug production."

4. Supplement Point e Clause 1 Article 17 as follows:

"e) A copy of the Certificate of Eligibility for Pharmaceutical Business stamped by the enterprise for the case of the enterprise applying for the first time to import sample drugs."

5. Amend Model No. 13a, 13b: Model No. 13a, Model No. 13b Appendix 5.

6. Amend Point b Clause 1 Article 22 as follows:

"b) An import permit document issued by the competent authority of the importing country (original, copy, or Vietnamese translation complying with the provisions of Paragraphs 1, 2, and 3 of Point a Clause 11 Article 4 of Circular No. 47/2010/TT-BYT)."

7. Repeal Point d Clause 1 Article 22.

Article 8. Effective Date

This Circular takes effect from February 5, 2012. All previous regulations contrary to this Circular are repealed.

During implementation, if there are difficulties or obstacles, please promptly reflect them to the Drug Administration of Vietnam under the Ministry of Health for study and amendment to make it suitable.