Circular 11/2025/TT-BYT amend Circular 02/2018/TT-BYT, Circular 03/2018/TT-BYT and Circular 36/2018/TT-BYT

CIRCULAR

Amending and supplementing a number of articles of the Circular No. 02/2018/TT-BYT dated January 22, 2018 of the Minister of Health on good pharmacy practices, Circular No. 03/2018/TT-BYT dated February 09, 2018 of the Minister of Health on good distribution practices and Circular No. 36/2018/TT-BYT dated November 22, 2018 of the Minister of Health on good storage practices

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Pursuant to the Law on Pharmacy dated April 06, 2016;

Pursuant to the Law Amending and Supplementing a Number of Articles of the Law on Pharmacy dated November 21, 2024;

Pursuant to the Government’s Decree No. 42/2025/ND-CP dated February 27, 2025, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the proposal of Directors of the Drug Administration of Vietnam and the Traditional Medicine Administration;

The Minister of Health promulgates the Circular amending and supplementing a number of articles of the Circular No. 02/2018/TT-BYT dated January 22, 2018 of the Minister of Health on good pharmacy practices, Circular No. 03/2018/TT-BYT dated February 09, 2018 of the Minister of Health on good distribution practices and Circular No. 36/2018/TT-BYT dated November 22, 2018 of the Minister of Health on good storage practices

Article 1. Amending, supplementing and repealing a number of articles and appendices of the Circular No. 02/2018/TT-BYT dated January 22, 2018 of the Minister of Health on good pharmacy practices

1. To amend and supplement Clause 1 Article 6 as follows:

“1. Receipt of dossiers:

The pharmacy shall submit a dossier as defined in Article 5 of this Circular, accompanied by the appraisal charge prescribed in the Ministry of Finance’s regulations on charges for appraisal of drug retail conditions and standards to the provincial-level People's Committee (the specialized agency assigned by the province to be in charge of pharmacy, hereinafter referred to as the provincial-level health agency).

2. To amend and repeal a number of clauses of Article 9 as follows:

a) To amend Clause 2 as follows:

“2. On November of every year, the provincial-level health agency shall announce on its website the list of pharmacies subject to the periodic assessment of maintenance of GPP requirement fulfillment in the subsequent year as specified in Clause 1 of this Article.”;

b) To amend Clause 3 as follows:

“3. At least 30 days prior to the due date for periodic assessment, the pharmacy must submit a report on maintenance of good pharmacy practice requirement fulfillment as defined at Point c Clause 7 of this Article to the provincial-level health agency.”;

c) To repeal Article 4;

d) To amend Point a Clause 7 as follows:

“a) A written request for GPP grant (in case the pharmacy so requests)”.

3. To amend a number of clauses of Article 10 as follows:

a) To amend Clause 1 as follows:

“1. In cases where the GPP assessment minutes conclude that the pharmacy meets GPP as defined at Point a, Clause 3, Article 7 of this Circular:

Within 10 days from the date of completion of the actual assessment at the pharmacy and signing of the assessment minutes, the provincial-level health agency shall issue a written notice on the pharmacy's maintenance of GPP requirement fulfillment or issue a certificate of GPP requirement fulfillment, made using the Form No. 03/GPP in Appendix III issued together with this Circular for cases where the pharmacy requests a certificate of GPP requirement fulfillment; and update the pharmacy's GPP requirement fulfillment status on the agency's website”;

b) To amend Point c Clause 2 as follows:

“c) Within 20 days from the date of receiving the report on remedial actions accompanied by evidence (documents, images, videos, certificates), the provincial-level health agency shall evaluate the results of the pharmacy's remedial actions and conclude on the pharmacy's GPP requirement fulfillment status as follows:

- In case the pharmacy's remedial actions meet the requirements: the provincial-level health agency shall issue a written notice on the pharmacy's maintenance of GPP requirement fulfillment or issue a certificate of GPP requirement fulfillment, made using the Form No. 03/GPP in Appendix III issued together with this Circular for cases where the pharmacy requests a certificate of GPP requirement fulfillment; and update the pharmacy's GPP requirement fulfillment status on the agency's website;

- In case the pharmacy's remedial actions do not yet meet the requirements:  the provincial-level health agency shall issue a written request detailing the issues to be remedied and submission of a supplementary report.  The extension period for continued remedial action and reporting shall be 45 days from the date of the written request”.

4. To add Article 15a after Article 15 as follows:

“Article 15a. Reference clauses

In case the legal normative documents and regulations mentioned in this Circular are changed, supplemented, or replaced, the new legal normative documents shall apply”.

5. To amend and supplement Article 16 as follows:

“Article 16. Transitional provision

For pharmacies that have been granted a certificate of eligibility for pharmaceutical business in the scope of drug retailing, upon expiration of their GPP certificates, the pharmacies must submit a report on the maintenance of good pharmacy practice requirement fulfillment as specified in Clause 3, Article 9 of this Circular”.

6. To amend and supplement a number of clauses of Article 17 as follows:

a) To amend Point c Clause 2 Article 17 as follows:

“c) To announce on the provincial-level health agencies’ websites the List of pharmacies in the localities that have been granted a certificate of eligibility for pharmaceutical business, update of the status of their certificates of eligibility for pharmaceutical business, GPP requirement fulfillment status and other information as specified in Clause 4, Article 8 of this Circular; to announce the List of pharmacies engaging in e-commerce business activities in the localities on their websites within 05 working days from the date of receiving the pharmacies’ written notification”;

b) To add Point d after Point c, Clause 17 as follows:

“d) To send a written notification directly or by post or to the email addresses of the provincial-level health agencies of the localities where the pharmacies’ business locations are located, before commencing e-commerce business activities, made using Form No. 05/GPP defined in Appendix III issued together with this Circular, and before ceasing e-commerce business activities, using Form No. 06/GPP defined in Appendix III issued together with this Circular”.

7. To amend Point c Clause 4 Section II Appendix I-1a as follows:

“c) The pharmacy must install IT equipment connected to the Internet and manage drug purchase and sale activities using application software; control over the origin, price, and source of drugs purchased and sold; ensure traceability of drugs; ensure full extraction of all such information data when requested by a management agency; and fully connect and update data with the pharmaceutical information system as guided by the Ministry of Health”.

8. To add Points d and dd after Point c in Clause 2, Section III, Appendix I-1a and Point d after Point c in Clause 2, Section III, Appendix I-1b as follows:

“d) E-commerce drug sales:

- Pharmacies engaging in e-commerce drug sales must organize online consultations and guidance through IT equipment regarding the contents defined at Points a and b of this Clause, methods of drug storage, and are only permitted to sell drugs after providing such consultation and guidance to the buyer.  The online consultation and guidance activities of pharmacies engaging in e-commerce drug sales must be carried out via audio conversations, videos, text messages, or other data messages; the pharmacies must store and record in the sales software at least the buyers’ contact information, a summary of the consultation and guidance provided, and archive them as evidence.
 The pharmacies must archive the evidence of online consultation and guidance for at least 24 months from the date of implementation;

- Packages used for drug transportation must include the following information:  Name and address of the buyer, name and address of the pharmacy, drug storage conditions, and the latest drug delivery time. The drug deliverer must be informed of the conditions related to drug storage and transportation and comply with these requirements throughout the transportation process;

- Drugs must be packaged, stored, and transported appropriately to ensure their integrity, prevent loss of product information, avoid contamination by other products, and maintain the drug storage conditions throughout the transportation process;

dd) When selling prescription drugs based on electronic medical prescriptions, the pharmacy must update the codes of electronic medical prescriptions into the system using the data on electronic medical prescriptions of the Ministry of Health, ensuring the connectivity with the Ministry of Health's system; sell drugs according to the prescriptions with the quantity sold not exceeding the quantity prescribed in the prescriptions, and not sell expired prescriptions.”

9. To amend Point c Clause 4 Section II Appendix I-1b as follows:

“c) The pharmacy must install IT equipment connected to the Internet and manage drug purchase and sale activities using application software; control over the origin, price, and source of drugs purchased and sold; ensure traceability of drugs; ensure full extraction of all such information data when requested by a management agency; and fully connect and update data with the pharmaceutical information system as guided by the Ministry of Health”.

10. To amend the “content” section of item 5.1.1, Appendix II-2a as follows:

“* Original or certified copy of legal papers (business registration certificate or decision on establishment of the pharmacy, for a drugstore in a public medical examination and treatment establishment), pharmacy practice certificate of the person in charge of professional pharmacy activities at the pharmacy, certificate of eligibility for pharmaceutical business (for a currently operating pharmacy)”.

11. To amend the “content” section of item 5.1.1, Appendix II-2b as follows:

“* Original or certified copy of legal papers (business registration certificate or decision on establishment of the pharmacy, for a drug dispensary in a public medical examination and treatment establishment), pharmacy practice certificate of the person in charge of professional pharmacy activities at the pharmacy, certificate of eligibility for pharmaceutical business (for a currently operating pharmacy)”.

12. Amend the content of paragraph 2, item 5.3.2, Appendix II-2a and item 5.3.2, Appendix II-2b as follows:

“(*) Install IT equipment connected to the Internet and manage drug purchase and sale activities using application software; control over the origin, price, and source of drugs purchased and sold; ensure traceability of drugs; store patients’ (paper or electronic) medical prescriptions. Ensure full extraction of all such information data when requested by a management agency; and fully connect and update data with the pharmaceutical information system as guided by the Ministry of Health”.

13. To amend the content “The drugstore must take measures to monitor the sale of prescription drugs” at item 7.6 of Appendix II-2a as follows:

“When selling prescription drugs based on electronic medical prescriptions, the drugstore must take measures to monitor the sale of prescription drugs, update the codes of electronic medical prescriptions into the system using the data on electronic medical prescriptions of the Ministry of Health, ensuring the connectivity with the Ministry of Health's system; sell drugs according to the prescriptions with the quantity sold not exceeding the quantity prescribed in the prescriptions, and not sell expired prescriptions”.

14. To add and repeal a number of forms in Appendix III as follows:

a) To add Form No. 04/GPP after Form No. 03/GPP, using Form No. 05 in the Appendix issued together with this Circular;

b) To add Form No. 05/GPP after Form No. 04/GPP, using Form No. 01 in the Appendix issued together with this Circular;

c) To add Form No. 06/GPP after Form No. 05/GPP, using Form No. 02 in the Appendix issued together with this Circular;

d) To repeal Form No. 01/GPP.

15. To replace some phrases used in the articles and appendices of the Circular as follows:

a) To replace the phrase “provincial-level Department of Health” with the phrase “the provincial-level health agency”;

b) To replace the phrase “the person in charge of professional activities” or “the professional manager” with the phrase “the person in charge of professional pharmacy activities of the pharmacy”;

c) To replace the phrase “specially managed drugs” with the phrase “drugs subject to special control”;

d) To replace the phrase “thuốc hướng tâm thần” (psychotropic medicines) with the phrase “thuốc hướng thần” (psychotropic drugs);

dd) To replace the phrase “medical devices” with the phrase “medical equipment”;

e) To replace the phrase “certificate of eligibility for drug business” with the phrase “certificate of eligibility for pharmaceutical business”;

g) To replace the phrase “the dossier of request for periodic assessment” with the phrase “the periodic assessment dossier” in Clause 6, Clause 7 Article 9 of the Circular.

Article 2. Amending, supplementing and repealing a number of articles and appendices of Circular No. 03/2018/TT-BYT dated February 09, 2018 of the Minister of Health on good distribution practices

1. To amend Point a Clause 2 Article 5 as follows:

“a. Legal papers regarding the establishment of the facility;”.

2. To amend Clause 1 Article 6 as follows:

“1. Receipt of dossiers:

The distributor shall submit a dossier as defined in Article 5 of this Circular, accompanied by the appraisal charge prescribed in the Minister of Finance’s regulations on charges for appraisal of standards and conditions for distribution of drugs and drug materials to the provincial-level People's Committee (the specialized agency assigned by the province to be in charge of pharmacy, hereinafter referred to as the provincial-level health agency). In case the distributor is an establishment organizing a chain of drugstores, the distributor shall submit 01 dossier together with the appraisal charge to the Drug Administration of Vietnam.”.

3. To amend the phrase “Form No. 06” in Clause 1, Point c Clause 2 Article 8 to the phrase “Form No. 07”.

4. To amend, supplement and repeal a number of clauses of Article 9 as follows:

a) To amend and supplement Clause 2 as follows:

“2. On November of every year, the provincial-level health agency shall announce on its website the List of distributors of drugs and drug materials subject to the periodic assessment of maintenance of GDP requirement fulfillment in the subsequent year as specified in Clause 1 of this Article, and the Drug Administration of Vietnam shall announce on its website the List of distributors of drugs and drug materials for cases where the distributor is an establishment organizing a chain of drugstores;”;

b) To amend and supplement Clause 3 as follows:

“3. At least 30 days prior to the due date for periodic assessment, the distributors of drugs and drug materials must submit a report on maintenance of good distribution practice requirement fulfillment as defined at Point c Clause 7 of this Article to the receiving agency;”;

c) To repeal Clause 4;

d) To amend Point a Clause 7 as follows:

“a) A written request for GDP grant (in case the facility so requests);”.

5. To amend a number of clauses of Article 10 as follows:

a) To amend Clause 1 as follows:

“1. In cases where the GDP assessment minutes conclude that the distributor meets GDP at level 1 as defined at Point a, Clause 2, Article 7 of this Circular:

Within 10 days from the date of completion of the actual assessment at the distributor of drugs and drug materials and signing of the assessment minutes, the receiving agency shall issue a written notice on the facility's maintenance of GDP requirement fulfillment or issue a certificate of GDP requirement fulfillment, made using the Form No. 07 in Appendix IV issued together with this Circular for cases where the facility requests a certificate of GDP requirement fulfillment; and update the facility's GDP requirement fulfillment status on the agency's website.”;

b) To amend Point c Clause 2 as follows:

“c) Within 20 days from the date of receiving the report on remedial actions accompanied by evidence (documents, images, videos, certificates), the receiving agency shall evaluate the results of remedial actions of the distributor of drugs and drug materials and conclude on its GDP requirement fulfillment status as follows:

- In case its remedial actions meet the requirements: the receiving agency shall issue a written notice on the facility's maintenance of GDP requirement fulfillment or issue a certificate of GDP requirement fulfillment, made using the Form No. 07 in Appendix IV issued together with this Circular for cases where the facility requests a certificate of GDP requirement fulfillment; and update the pharmacy's GDP requirement fulfillment status on the agency's website;

- In case its remedial actions do not yet meet the requirements: the receiving agency shall issue a written request detailing the issues to be remedied and submission of a supplementary report. The extension period for continued remedial action and reporting shall be 45 days from the date of the written request.”.

6. To amend and supplement a number of clauses of Article 13 as follows:

a) To amend Clause 1 as follows:

“1. Components of the assessment team:

The head of the team, the secretary, and other members as decided by the head of the receiving agency. The number of members in the assessment team shall not exceed 05 people.”;

b) To amend Point a Clause 2 as follows:

“a) To be civil servants or public employees of the provincial-level health agency or civil servants, public employees, or cadres under contracts in units directly under the provincial-level health agency.  For the assessment team of an establishment organizing a chain of drugstores, the assessment team members shall be civil servants or public employees of the Drug Administration of Vietnam and representatives of the provincial-level health agency of the province where the distributor's head office is located;”.

7. To amend a number of clauses of Article 17 as follows:

a) To repeal Clause 1;

b) To amend Clause 2 as follows:

“2. For distributors that have been granted a certificate of eligibility for pharmaceutical business for an indefinite period, upon expiration of their certificates of GDP requirement fulfillment, the distributors must submit a report on the maintenance of good distribution practice requirement fulfillment as specified in Clause 3, Article 9 of this Circular.”;

c) To repeal Clause 3.

8. To amend and supplement a number of clauses of Article 18 as follows:

a) To amend Point c Clause 3 Article 18 as follows:

“c) To announce on the provincial-level health agencies’ websites the List of establishments wholesaling drugs or drug materials that have been granted a certificate of eligibility for pharmaceutical business in the localities, GDP requirement fulfillment status and other information as specified in Clause 4, Article 8 of this Circular; to announce the List of establishments wholesaling drugs or drug materials engaging in e-commerce business activities in the localities on their websites within 05 working days from the date of receiving the facilities’ written notification;”;

b) To add Point d after Point c Clause 4 Article 18 as follows:

“d) To send a written notification to the provincial-level health agencies of the localities where the facilities’ business locations are located, before commencing e-commerce business activities, made using Form No. 08 in Appendix IV issued together with this Circular, and before ceasing e-commerce business activities, using Form No. 09 in Appendix IV issued together with this Circular. The written notification shall be sent directly or by post or to the email addresses of the provincial-level health agencies. An establishment organizing a chain of drugstores shall notify the provincial-level health agency of the list of drugstores engaging in e-commerce business activities in the localities.”.

9. To amend and supplement a number of items of Appendix I as follows:

a) To amend item 14.11 in Clause 14 as follows:

“14.11. The facility must install IT equipment connected to the Internet and manage  drug or drug material distribution activities using application software; control over the origin, price, and source of drugs purchased and sold; ensure traceability of drugs and drug materials; ensure full extraction of all such information data when requested by a management agency; and fully connect and update data with the pharmaceutical information system as guided by the Ministry of Health.”;

b) To add item 14.16 in Clause 14 as follows:

“14.16. For establishments organizing a chain of drugstores, all activities related to the supply, circulation, inventory, storage of drugs and data related to buyers at all drugstores in the chain must be managed by the same process, controlled by the person in charge of professional pharmacy activities of the establishment, ensuring traceability of batch numbers, expiry dates, import/export/inventory history, buyer information (with confidentiality compliance) and seamless connection between drugstores and their head office.”.

10. To amend, add and repeal a number of forms in Appendix IV as follows:

a) To add Form No. 07/GDP after Form No. 06/GDP, using Form No. 03 in the Appendix issued together with this Circular;

b) To add Form No. 08/GDP after Form No. 07/GDP, using Form No. 01 in the Appendix issued together with this Circular;

c) To add Form No. 09/GDP after Form No. 08/GDP, using Form No. 02 in the Appendix issued together with this Circular;

d) To replace Form No. 04/GDP, using Form No. 07 in the Appendix issued together with this Circular;

dd) To replace Form No. 05/GDP, using Form No. 08 in the Appendix issued together with this Circular;

e) To repeal Form No. 01/GDP, Form No. 02/GDP.

11. To replace some phrases used in the articles of the Circular as follows:

a) To replace the phrase “Vaccine distribution facilities in the National Expanded Immunization Program at the provincial and district levels” with the phrase “Vaccine distribution facilities in the National Expanded Immunization Program at the provincial level and agencies assigned to manage immunization at the commune level” in Clause 4 Article 2 and Clause 3 Article 4;

b) To replace the phrase “the dossier of request for assessment” with the phrase “the assessment dossier” in Clause 6, Clause 7 Article 9 and Point b Clause 3 Article 18;

c) To replace the phrase “the Department of Health of the province or centrally-run city”, “the provincial-level Department of Health” with the phrase “the provincial-level health agency” in the Circular. In Clause 3 Article 6, Article 7, Article 8, Points a, b, d Clause 2, Clause 3 and Clause 4 Article 10, Article 11, Article 12, to amend the phrase “Provincial-level Department of Health” to the phrase “The receiving agency”;

d) To replace the phrase “certificate of eligibility for drug business” with the phrase “certificate of eligibility for pharmaceutical business” in the Appendix IV.

Article 3. Amending, supplementing and repealing a number of articles and appendices of the Circular No. 36/2018/TT-BYT dated November 22, 2018 of the Minister of Health on good storage practices

1. To amend and supplement a number of clauses of Article 5 as follows:

a) To amend Clause 2 as follows:

“2. In case the establishment requests a GSP certificate together with a certificate of eligibility for pharmaceutical business, the establishment must clearly state this content in the application for grant of a certificate of eligibility for pharmaceutical business. In case the establishment has been granted a certificate of eligibility for pharmaceutical business and wishes to obtain a GSP certificate, the establishment shall submit a written request for grant of a GSP certificate. The receiving agency shall consider issuing the GSP certificate based on the results of the most recent previous GSP assessment.”;

b) To add Clause 3 after Clause 2 as follows:

“3. In case an establishment engaged in pharmacy activities for non-commercial purposes wishes to obtain a GSP certificate, the establishment shall submit a written request for grant of a GSP certificate accompanied by technical documents according to the guidance on the overall dossier of the preserving establishment defined in Appendix VI issued together with this Circular. The receiving agency shall consider the assessment and grant of the GSP certificate.”.

2. To amend and supplement Clause 1 Article 9 as follows:

“1. The periodic assessment period for maintenance of GSP requirement fulfillment at the preserving establishment is 03 years, counting from the date of signing the immediately preceding assessment minutes (excluding ad-hoc assessments, inspections, or examinations by the Ministry of Health, provincial-level People's Committees (the specialized agencies assigned by the provinces to be in charge of pharmacy, hereinafter referred to as the provincial-level health agencies)).”.

3. To amend and supplement a number of clauses of Article 10 as follows:

a) To amend Clause 1 as follows:

“1. In cases where the GSP assessment reports conclude that the drug and drug material storage establishments meet GSP at level 1 as defined at Point a, Clause 3, Article 7 of this Circular:

Within 10 days from the date of completion of the actual assessment at the establishment, the receiving agency shall issue a written notice on the establishment's maintenance of GSP requirement fulfillment or issue a certificate of GSP requirement fulfillment, made using the Form No. 05 in Appendix VII issued together with this Circular for cases where the establishment requests a certificate of GSP requirement fulfillment; and update the establishment's GSP requirement fulfillment status on the agency's website.”;

b) To amend Point c Clause 2 as follows:

“c) Within 20 days from the date of receiving the report on remedial actions of the drug or drug material storage establishment, the receiving agency shall evaluate the results of remedial actions of the drug or drug material storage establishment and conclude on its GSP requirement fulfillment status as follows:

- In case the establishment’s remedial actions meet the requirements: the receiving agency shall issue a written notice on the establishment's maintenance of GSP requirement fulfillment or issue a certificate of GSP requirement fulfillment, made using the Form No. 05 in Appendix VII issued together with this Circular for cases where the establishment requests a certificate of GSP requirement fulfillment; and update the establishment's GSP requirement fulfillment status on the agency's website.

- In case the establishment's remedial actions do not yet meet the requirements: the receiving agency shall issue a notice detailing the issues to be remedied and submission of a supplementary report. The extension period for continued remedial action and reporting shall be 45 days from the date of the written request.”.

4. To repeal Clause 1, Clause 3 Article 21.

5. To add a number of clauses in Article 22 as follows:

a) To add Point d after Point c Clause 3 Article 22 as follows:

“d) To announce the List of establishments exporting, importing drugs and drug materials, and wholesaling drugs and drug materials engaging in e-commerce business activities in the localities on the websites of the provincial-level health agencies within 05 working days from the date of receiving the establishments’ written notification;”;

b) To add Point dd after Point d, Clause 4 Article 22 as follows:

“dd) To send a written notification directly or by post or to the email addresses of the provincial-level health agencies of the localities where the establishments’ business locations are located, before commencing e-commerce business activities, using Form No. 07 defined in Appendix VII issued together with this Circular, and before ceasing e-commerce business activities, using Form No. 08 defined in Appendix VII issued together with this Circular.”.

6. To amend a number of contents in Appendix I as follows:

a) Amend the content “Sampling of raw materials, handling of sampling tools” in item 5.3, Clause 5 as follows:

“- In case the sampling of raw material is required, the sampling of raw materials and handling of sampling tools shall be carried out in the sampling area of the establishment or under a contract with another establishment that has a raw material sampling area meeting the requirements as defined in item 5.6 of this appendix.”;

b) To amend item 5.6 in Clause 5 as follows:

“5.6. For establishments with a raw material sampling area, this area must be designed and equipped with a system of equipment that meets the regulations on sampling areas for drug materials as specified in the Ministry of Health's circular on good manufacturing practices.”;

c) To amend item 5.11 in Clause 5 as follows:

“5.11. To install IT equipment connected to the Internet and manage storage activities of drugs and drug materials using application software. To establish a mechanism for connection of information from the import, export, and distribution of drugs and drug materials to customers; ensure traceability of drugs and drug materials; ensure full extraction of all such information data when requested by a management agency; and fully connect and update data with the pharmaceutical information system as guided by the Ministry of Health.”;

d) To amend item 8.4 in Clause 8 as follows:

“8.4. Foreign-invested pharmaceutical business establishments are only permitted to deliver and dispatch goods to establishments wholesaling drugs or drug materials at the establishments’ own drug and drug material storage warehouses, transport goods from the customs warehouses to the establishments’ warehouses or between their warehouses, and carry out delivery and transport activities as specified at Points d, dd and e Clause 3 Article 53a of the Pharmacy Law. For radioactive drugs with an expiry date of 30 days or fewer, the establishment may comply with item 9.11, Clause 9, Appendix I.”;

dd) To amend item 9.11 in Clause 9 as follows:

“9.11. A procedure for importing and exporting goods, which takes into account the nature of drugs or drug materials, and necessary preventive measures is required. For radioactive drugs with an expiry date of 30 days or fewer: The establishment may transfer drugs from the import port to the place of drug use; the import and export procedures must clearly specify the steps, the responsibilities of relevant personnel, and the records of implementation for this case to ensure the management of the import and export process and control over radioactive drugs.”;

e) To amend item 9.18 in Clause 9 as follows:

“9.18. A procedure specifying the frequency and method of cleaning warehouses and storage areas; a procedure for cleaning drug and drug material sampling areas (for establishments with sampling areas).”.

7. To amend a number of contents in Appendix III as follows:

a) To amend the content “Sampling of raw materials, handling of sampling tools” in item 2.3, Clause 2 as follows:

“- In case the sampling of raw material is required, the sampling of raw materials and handling of sampling tools shall be carried out in the sampling area of the establishment or under a contract with another establishment that has a raw material sampling area meeting the requirements as defined in item 2.6 of this appendix.”;

b) To amend item 2.6 in Clause 2 as follows:

“2.6. For establishments with a raw material sampling area, this area must be designed and equipped with a system of equipment that meets the regulations on sampling areas for drug materials as specified in the Ministry of Health's circular on good manufacturing practices.”;

c) To amend item 2.12 as follows:

“2.12. To install IT equipment connected to the Internet and manage storage activities of drugs and drug materials using application software. To establish a mechanism for connection of information from the import, export, and distribution of drugs and drug materials to customers; ensure traceability of drugs and drug materials; ensure full extraction of all such information data when requested by a management agency; and fully connect and update data with the pharmaceutical information system as guided by the Ministry of Health.”;

c) To repeal item 5.4 in Clause 5;

d) To amend item 6.18 in Clause 6 as follows:

“6.18. A procedure specifying the frequency and method of cleaning warehouses and storage areas; a procedure for cleaning drug and drug material sampling areas (for establishments with sampling areas).”.

8. To amend and add a number of forms in Appendix VII as follows:

a) To replace Form No. 01, using Form No. 04 in the Appendix issued together with this Circular;

b) To replace Form No. 05, using Form No. 06 in the Appendix issued together with this Circular;

c) To add Form No. 07 after Form No. 06, using Form No. 01 in the Appendix issued together with this Circular;

d) To add Form No. 08 after Form No. 07, using Form No. 02 in the Appendix issued together with this Circular.

9. To amend some phrases used in the articles and appendices of the Circular as follows:

a) To amend the phrase “certificate of eligibility for drug business” to the phrase “certificate of eligibility for pharmaceutical business” in the Appendix VI of the Circular;

b) To amend the phrase “Vaccine storage establishments in the National Expanded Immunization Program at the district level” to “agencies assigned to manage immunization at the commune level”;

c) To amend the phrase “the Department of Health of the province or centrally-run city”, “the provincial-level Department of Health” to the phrase “the provincial-level health agency”;

d) To repeal the phrase “(hereinafter referred to as the provincial-level Department of Health)”.

Article 4. Amending and repealing a number of articles and clauses of Circulars amending and supplementing a number of articles of the Circular No. 02/2018/TT-BYT dated January 22, 2018 of the Minister of Health on good pharmacy practices, and Circular No. 03/2018/TT-BYT dated February 09, 2018 of the Minister of Health on good distribution practices

1. To amend and repeal a number of articles of Circular No. 12/2020/TT-BYT dated June 22, 2020 of the Minister of Health, on amending and supplementing a number of articles of the Circular No. 02/2018/TT-BYT dated January 22, 2018 of the Minister of Health on good pharmacy practices as follows:

a) To repeal Clause 6 Article 1;

b) To amend the phrase “the dossier of request for periodic assessment” to the phrase “the periodic assessment dossier” in Clause 8 and Clause 9 Article 1;

c) To amend the phrase “provincial-level Department of Health” to the phrase “the provincial-level health agency”.

2. To amend and repeal a number of articles of Circular No. 09/2020/TT-BYT dated June 10, 2020 of the Minister of Health, on amending and supplementing a number of articles of the Circular No. 03/2018/TT-BYT dated February 09, 2018 of the Minister of Health on good distribution practices as follows:

a) To repeal Clause 6 and Clause 11 Article 1;

b) To amend the phrase “the dossier of request for periodic assessment” to the phrase “the periodic assessment dossier” in Clause 7 Article 1;

c) To amend the phrase “provincial-level Department of Health” to the phrase “the provincial-level health agency”.

Article 5. Effect

1. This Circular takes effect on July 01, 2025.

2. Regulations on pharmaceutical business establishments connecting and fully updating data with the pharmaceutical information system as guided by the Ministry of Health shall be implemented from January 01, 2026.

Article 6. Transitional provision

Dossiers submitted before the effective date of this Circular shall continue to be processed in accordance with the regulations effective at the time of submission or this Circular from July 01, 2025, in a manner that facilitates and simplifies administrative procedures applicable to enterprises, organizations, and individuals.

Article 7. Responsibility of implementation

1. The Drug Administration of Vietnam shall be responsible for:

a) Assuming the prime responsibility for, and coordinating with relevant units in, disseminating this Circular;

b) Acting as the focal point, coordinating with relevant units to provide the guidance on the implementation of the Circular to provincial-level health agencies, sectoral health agencies, and pharmaceutical business establishments within its assigned functions and tasks;

c) Inspecting compliance with this Circular and handling or proposing the handling of violations according to its competence.

2. The Traditional Medicine Administration shall be responsible for:

a) Acting as the focal point, coordinating with relevant units to provide the guidance on the implementation of the Circular to provincial-level health agencies, sectoral health agencies, and establishments distributing traditional drugs and medicinal materials within its assigned functions and tasks;

b) Inspecting compliance with this Circular and handling or proposing the handling of violations according to its competence.

3. Provincial-level People's Committees shall be responsible for directing its affiliated agencies to inspect the compliance with the principles and good practice standards of pharmaceutical business establishments in the localities and directing the provincial-level health agencies to perform the following tasks:

a) Coordinating with relevant units in disseminating this Circular and guiding the implementation for units in the localities;

b) Inspecting the compliance with this Circular and handling violations according to their competence.

4. Pharmaceutical business establishments shall be responsible for:

a) Organizing research and implementing this Circular;

b) Ensuring compliance with good practice standards throughout the operation of the establishments;

c) Conducting their business activities involving drugs and drug materials within the licensed scope based on compliance with law regulations.

Any problems arising in the course of implementation of this Circular should be promptly reported to the Ministry of Health (the Drug Administration of Vietnam) for timely consideration and handling./.

* All Appendices are not translated herein.