Circular No. 11/2025/TT-BYT amends and supplements some articles of Circular No. 02/2018/TT-BYT dated January 22, 2018, issued by the Minister of Health on Good Pharmacy Practice for Retail Drug Outlets, Circular No. 03/2018/TT-BYT dated February 9, 2018, issued by the Minister of Health on Good Distribution Practice for Drugs and Active Pharmaceutical Ingredients, and Circular No. 36/2018/TT-BYT dated November 22, 2018, issued by the Minister of Health on Good Storage Practice for Drugs and Active Pharmaceutical Ingredients.

CIRCULAR

Amending and supplementing some articles of Circular No. 02/2018/TT-BYT dated January 22, 2018, issued by the Minister of Health on Good Pharmacy Practice for Retail Drug Outlets, Circular No. 03/2018/TT-BYT dated February 9, 2018, issued by the Minister of Health on Good Distribution Practice for Drugs and Active Pharmaceutical Ingredients, and Circular No. 36/2018/TT-BYT dated November 22, 2018, issued by the Minister of Health on Good Storage Practice for Drugs and Active Pharmaceutical Ingredients.

Circular No. 249/2025/NĐ-CP dated January 2018 of the Minister of Health on good retail pharmacy practice

Circular No. 03/2018/TT-BYT dated February 9, 2018 of the Minister of Health on good distribution practice for medicinal products and active pharmaceutical ingredients

Circular No. 36/2018/TT-BYT dated November 22, 2018 of the Minister of Health on good storage practice for medicinal products and active pharmaceutical ingredients

concerning medicinal drugs, Circular No. 36/2018/TT-BYT dated November 22, 2018

of the Minister of Health on good storage practices for medicinal drugs, raw

materials for drug production

                    

BASED ON THE PHARMACEUTICAL LAW dated April 6, 2016;

Pursuant to the Law Amending and Supplementing Certain Provisions of the Medicine Law dated November 21, 2024;

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

At the proposal of the Director of the Department of Medicine Management, the Director of the Department of Traditional Medicine and Pharmaceutical Management;

The Minister of Health issues this Circular amending and supplementing some articles of Circular No. 02/2018/TT-BYT dated January 22, 2018, issued by the Minister of Health on Good Pharmacy Practice for Retail Drug Outlets, Circular No. 03/2018/TT-BYT dated February 9, 2018, issued by the Minister of Health on Good Distribution Practice for Drugs and Active Pharmaceutical Ingredients, and Circular No. 36/2018/TT-BYT dated November 22, 2018, issued by the Minister of Health on Good Storage Practice for Drugs and Active Pharmaceutical Ingredients.

Article 1. Amending, supplementing, and abolishing some articles and appendices of Circular No. 02/2018/TT-BYT dated January 22, 2018, issued by the Minister of Health on Good Pharmacy Practice for Retail Drug Outlets.

1. Amending and supplementing Clause 1 of Article 6 as follows:

"1. Submission of application dossier:

The retail drug outlet shall submit one set of application dossier in accordance with Article 5 of this Circular along with the fee for assessment as prescribed by the Ministry of Finance regarding the fee for assessing conditions and standards for retail drug sales to the People's Committee of the province (the specialized agency assigned by the province to be responsible for pharmaceutical affairs, hereinafter referred to as the specialized health agency of the province).

2. Amending and abolishing some clauses of Article 9 as follows:

a) Amending Clause 2 as follows:

"2. In November each year, the specialized health agency of the province shall publish on its website the list of retail drug outlets that must undergo periodic evaluation to maintain compliance with GPP in the following year in accordance with Clause 1 of this Article";

b) Amending Clause 3 as follows:

"3. At least 30 days before the deadline for periodic evaluation, the retail drug outlet must submit a report on maintaining compliance with good pharmacy practice in accordance with Point c of Clause 7 of this Article to the specialized health agency of the province";

c) Abolishing Clause 4;

d) Amending Point a of Clause 7 as follows:

"a) A request for issuance of GPP certificate (in case the outlet requests it)";

3. Amending some clauses of Article 10 as follows:

a) Amend Clause 1 as follows:

"1. In the case where the GPP inspection report concludes that the retail drug outlet complies with GPP as stipulated in Point a of Clause 3 of Article 7 of this Circular:

Within ten days from the date of completing the actual inspection at the retail drug outlet and signing the inspection report, the specialized health agency of the province shall issue a notification on the maintenance of compliance with GPP by the outlet or issue a Certificate of Compliance with GPP according to Model No. 03/GPP prescribed in Appendix III attached to this Circular in case the outlet requests issuance of such a certificate; the specialized health agency of the province shall update the status of compliance with GPP of the outlet on its website";

b) Amending Point c of Clause 2 as follows:

"c) Within twenty days from the date of receipt of the corrective action report accompanied by evidence (documentary files, images, videos, certificates) proving the correction, the specialized health agency of the province shall evaluate the results of the corrective actions by the retail drug outlet and conclude on the status of compliance with GPP of the retail drug outlet as follows:

- In the case where the corrective actions by the retail drug outlet meet the requirements: the specialized health agency of the province shall issue a notification on the maintenance of compliance with GPP by the outlet or issue a Certificate of Compliance with GPP according to Model No. 03/GPP prescribed in Appendix III attached to this Circular in case the outlet requests issuance of such a certificate; the specialized health agency of the province shall update the status of compliance with GPP of the outlet on its website;

- In the case where the corrective actions by the retail drug outlet do not meet the requirements: the specialized health agency of the province shall issue a notice requesting further corrective actions and submission of additional reports. The extended period for further corrective actions and reporting is forty-five days from the date of the notice";

4. Adding Article 15a after Article 15 as follows:

“Article 15a. Cross-referencing Provisions

In cases where legal regulatory documents and provisions cited in this Circular have been amended, supplemented, or replaced, they shall be applied according to the new legal regulatory documents.

5. Amend and supplement Article 16 as follows:

“Article 16. Transitional Provisions

For retail drug outlets that have been granted a Certificate of Compliance for Retail Drug Business Operations within their scope of business, upon expiration of the Good Pharmacy Practice (GPP) certificate, the retail drug outlet must submit a report on maintaining compliance with good retail pharmacy practices in accordance with Clause 3, Article 9 of this Circular.

6. Amend and supplement some clauses of Article 17 as follows:

a) Amend Point c, Clause 2, Article 17 as follows:

“c) Publish on the website of the health authority of the province a list of retail drug outlets within its jurisdiction that have been granted a Certificate of Compliance for Drug Business Operations, update the status of the Certificate of Compliance for Drug Business Operations, the status of compliance with GPP, and other information as prescribed in Clause 4, Article 8 of this Circular; publish on the website of the health authority of the province a list of retail drug outlets operating through e-commerce within its jurisdiction within five working days from the date of receipt of the notification document from the outlet.”

b) Add Point d after Point c, Clause 3, Article 17 as follows:

“d) Send a written notice directly or via postal service or to the email address of the health authority of the province where the outlet is located before commencing operations through e-commerce using Model 05/GPP prescribed in Appendix III attached hereto prior to ceasing operations through e-commerce using Model 06/GPP prescribed in Appendix III attached hereto.”

7. Amend Point c, Clause 4, Part II, Appendix I-1a as follows:

“c) The outlet must have internet-connected information technology equipment and manage drug buying and selling activities through application software; ensure control over the origin, price, and source of drugs purchased and sold; ensure traceability of drug origin; ensure full extraction of data when requested by the management agency; link and fully update data with the pharmaceutical information system in accordance with the guidelines of the Ministry of Health.”

8. Add Points d and đ after Point c, Clause 2, Part III, Appendix I-1a and Point d after Point c, Clause 2, Part III, Appendix I-1b as follows:

“d) Selling drugs through e-commerce:

- Retail drug outlets operating through e-commerce must organize online counseling and guidance through information technology devices and technologies regarding the contents stipulated in Points a and b of this clause, methods of drug storage, and may only sell drugs after providing counseling and guidance to the buyer. Online counseling and guidance activities of retail drug outlets operating through e-commerce must be recorded in audio, video, or data messages; the outlet must record in the sales software at least the contact information of the buyer, a summary of the counseling and guidance provided, and retain it as evidence. The outlet must retain evidence of online counseling and guidance for at least twenty-four months from the date of implementation;

- Packaging for drug transportation must include the following information: Name and address of the drug purchaser, name and address of the retail drug outlet, storage conditions for the drug, and the latest delivery time limit. The drug transporter must be informed of the conditions related to drug storage and transportation and must comply with these requirements throughout the transportation process;

- Drugs must be packaged, stored, and transported appropriately to maintain the integrity of the drug, not lose product information, not be contaminated by other products, and maintain the storage conditions of the drug throughout the transportation process;

đ) When selling prescription drugs based on electronic prescriptions, the outlet must update the electronic prescription code into the system using the electronic prescription data of the Ministry of Health, ensuring linkage to the Ministry of Health's system; sell drugs strictly according to the prescription, the quantity of drugs sold should not exceed the quantity specified in the prescription, and do not sell expired prescriptions.”

9. Amend Point c, Clause 4, Part II, Appendix I-1b as follows:

“c) The outlet must have internet-connected information technology equipment and manage drug buying and selling activities through application software; ensure control over the origin, price, and source of drugs purchased and sold; ensure traceability of drug origin; ensure full extraction of data when requested by the management agency; link and fully update data with the pharmaceutical information system in accordance with the guidelines of the Ministry of Health.”

10. Amend the "content" part of Item 5.1.1, Appendix II-2a as follows:

“* Original or certified copy of legal documents (business registration or establishment decision for the facility if it is a public healthcare facility’s pharmacy), professional qualification certificate of the person responsible for pharmaceutical matters at the facility, Certificate of Compliance for Drug Business Operations (for operating facilities).”

11. Amend the "content" part of Item 5.1.1, Appendix II-2b as follows:

“* Original or certified copy of legal documents (business registration or establishment decision for the facility if it is a public healthcare facility’s pharmacy counter), professional qualification certificate of the person responsible for pharmaceutical matters at the facility, Certificate of Compliance for Drug Business Operations (for operating facilities).”

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

“(*) Have internet-connected information technology equipment and manage drug buying and selling activities through application software; ensure control over the origin, price, and source of drugs purchased and sold; ensure traceability of drug origin; retain patient prescriptions (paper or electronic). Ensure full extraction of data when requested by the management agency; link and fully update data with the pharmaceutical information system in accordance with the guidelines of the Ministry of Health.”

13. Amend the content: "The pharmacy has measures to monitor the sale of prescription drugs" in Item 7.6, Appendix II-2a as follows:

"The pharmacy has measures to monitor the sale of prescription drugs, update the electronic prescription code into the system using the electronic prescription data of the Ministry of Health when selling prescription drugs based on electronic prescriptions, ensuring linkage to the Ministry of Health's system; sell drugs strictly according to the prescription, the quantity of drugs sold should not exceed the quantity specified in the prescription, and do not sell expired prescriptions."

14. Supplement and abolish forms in Appendix III as follows:

a) Add Form number 04/GPP after Form number 03/GPP according to Model number 05 in the Appendix issued together with this Circular;

b) Add Form number 05/GPP after Form number 04/GPP according to Model number 01 in the Appendix issued together with this Circular;

c) Add Form number 06/GPP after Form number 05/GPP according to Model number 02 in the Appendix issued together with this Circular;

d) Repeal Form number 01/GPP.

15. Replace some phrases used in Articles and Appendices of this Circular as follows:

a) Replace the phrase "Department of Health" with the phrase "specialized health agency of the province";

b) Replace the phrase "person responsible for professional matters" or "professional management person" with the phrase "Person responsible for professional pharmaceutical matters of the facility";

c) Replace the phrase "special managed drugs" with the phrase "drugs requiring special control";

d) Replace the phrase "psychotropic drugs" with the phrase "psychotropic substances";

đ) Replace the phrase "medical devices" with the phrase "medical equipment";

e) Replace the phrase "certificate of eligibility for drug business" with the phrase "certificate of eligibility for pharmaceutical business";

g) Replace the phrase "periodic review application file" with the phrase "periodic review file" in Clause 6, Clause 7 Article 9 of this Circular.

Article 2. Amend, supplement, and abolish some Articles and Appendices of Circular No. 03/2018/TT-BYT dated February 9, 2018, of the Minister of Health on Good Distribution Practices for Drugs and Active Pharmaceutical Ingredients.

1. Amend Point a Clause 2 Article 5 as follows:

 "a. Legal documents regarding the establishment of the facility;"

2. Amend Clause 1 Article 6 as follows:

"1. Submission of application dossier:

The distribution facility submits one set of files as prescribed in Article 5 of this Circular along with the fee for assessment as stipulated by the Minister of Finance on fees for assessing standards and conditions for drug distribution and active pharmaceutical ingredient distribution to the People's Committee of the province (the specialized agency assigned by the province to be responsible for pharmaceuticals, hereinafter referred to as the specialized health agency of the province). In case the distribution facility is a chain pharmacy facility, it submits one set of files along with the assessment fee to the Drug Administration Department."

3. Amend the phrase "Form number 06" at Clause 1, Point c Clause 2 Article 8 to the phrase "Form number 07".

4. Amend, supplement, and abolish some Clauses of Article 9 as follows:

a) Amend and supplement Clause 2 as follows:

"2. By November each year, the specialized health agency of the province publishes on its website the list of drug distribution facilities and active pharmaceutical ingredient distribution facilities that need to undergo periodic evaluation to maintain compliance with GDP in the following year as stipulated in Clause 1 of this Article, and the Drug Administration Department publishes on its website the list of drug distribution facilities and active pharmaceutical ingredient distribution facilities for cases where the distribution facility is a chain pharmacy facility;"

b) Amend and supplement Clause 3 as follows:

"3. At least 30 days before the deadline for periodic evaluation, the drug distribution facility and active pharmaceutical ingredient distribution facility must submit a report on maintaining compliance with good distribution practices for drugs and active pharmaceutical ingredients as prescribed in Point c Clause 7 of this Article to the receiving authority;"

c) Abolishing Clause 4;

d) Amending Point a of Clause 7 as follows:

"a) Request for issuance of GDP (in case the facility requests issuance);"

5. Amend some Clauses of Article 10 as follows:

a) Amend Clause 1 as follows:

"1. In case the GDP assessment report concludes that the distribution facility complies with GDP at level 1 as stipulated in Point a Clause 2 Article 7 of this Circular:

Within 10 days from the date of completing the actual assessment at the drug distribution facility and active pharmaceutical ingredient distribution facility and signing the assessment report, the receiving authority shall issue a notification on the maintenance of GDP compliance of the facility or issue a Certificate of GDP Compliance according to Form number 07 prescribed in Appendix IV issued together with this Circular in case the facility requests issuance of the Certificate of GDP Compliance; the receiving authority shall update the GDP compliance status of the facility on its website;"

b) Amending Point c of Clause 2 as follows:

"c) Within 20 days from the date of receipt of the corrective action report accompanied by evidence (documentary evidence, images, videos, certificates) proving the correction, the receiving authority shall evaluate the results of the corrective actions of the drug distribution facility and active pharmaceutical ingredient distribution facility and conclude on the GDP compliance status of the facility as follows:

- If the corrective actions of the drug distribution facility and active pharmaceutical ingredient distribution facility meet the requirements: The receiving authority shall issue a notification on the maintenance of GDP compliance of the facility or issue a Certificate of GDP Compliance according to Form number 07 prescribed in Appendix IV issued together with this Circular in case the facility requests issuance of the Certificate of GDP Compliance; the receiving authority shall update the GDP compliance status of the facility on its website;

- If the corrective actions of the drug distribution facility and active pharmaceutical ingredient distribution facility do not meet the requirements: The receiving authority shall issue a notice requesting further corrective actions and submission of additional reports. The extended period for further corrective actions and submission of reports is 45 days from the date of the notice;"

6. Amend and supplement some Clauses of Article 13 as follows:

a) Amend Clause 1 as follows:

"1. Composition of the assessment team:

The head of the team, the secretary, and other members are decided by the head of the receiving authority. The number of members in the assessment team shall not exceed five people.";

b) Amending Point a Clause 2 as follows:

"a) They are civil servants or employees of the provincial specialized health agency or civil servants, employees, and contractual staff of units under the provincial specialized health agency. For the assessment team of chain pharmacy facilities, the members of the assessment team are civil servants or employees of the Drug Administration Department and representatives of the provincial specialized health agency where the distribution facility is located;"

7. Amend some Clauses of Article 17 as follows:

a) Repeal Clause 1;

b) Amend Clause 2 as follows:

"2. For distribution facilities that have been issued an indefinite certificate of eligibility for pharmaceutical business, when the GDP certification period expires, the distribution facility must submit a report on maintaining compliance with good distribution practices for drugs and active pharmaceutical ingredients as prescribed in Clause 3 of Article 9 of this Circular;"

c) Repeal Clause 3.

8. Amend and supplement some Clauses of Article 18 as follows:

a) Amend Point c Clause 3 Article 18 as follows:

"c) Publish on the website of the specialized health agency of the province a list of wholesale drug establishments and raw material manufacturers that have been issued a Business Registration Certificate for pharmaceutical activities within its jurisdiction, their compliance status with Good Distribution Practices (GDP), and other information as prescribed in Clause 4, Article 8 of this Circular; publish on the website of the specialized health agency of the province a list of wholesale drug establishments and raw material manufacturers operating through electronic commerce within its jurisdiction within five working days from the date of receipt of the notification letter from such establishments;"

b) Add Point d following Point c of Clause 4, Article 18 as follows:

"d) Send a notification letter to the specialized health agency of the province where the establishment conducts business before commencing operations through electronic commerce according to Model No. 08 attached as Appendix IV of this Circular, and before ceasing operations through electronic commerce according to Model No. 09 attached as Appendix IV of this Circular. The notification letter shall be sent directly, via postal service, or to the email address of the specialized health agency of the province. A chain pharmacy establishment shall notify the specialized health agency of the province of the list of pharmacies conducting business through electronic commerce within its jurisdiction."

9. Amend and supplement some items of Appendix I as follows:

a) Amend Item 14.11 of Clause 14 as follows:

"14.11. The establishment must have internet-connected information technology equipment and manage drug distribution and raw material procurement activities using application software; ensure traceability of origin, pricing, and source of purchased and sold drugs; ensure traceability of the origin of drugs and raw materials; ensure full extraction of relevant data when requested by the management authority; interconnect and update all data with the pharmaceutical information system according to the guidelines of the Ministry of Health."

b) Add Item 14.16 of Clause 14 as follows:

"14.16. For chain pharmacy establishments, all activities related to drug supply, circulation, storage, preservation, and related data on drug purchasers at all pharmacies in the chain must be managed through the same process under the control of the person responsible for pharmaceutical matters at the establishment, ensuring the ability to track production batches, expiration dates, transaction history, purchaser information (complying with confidentiality requirements), and seamless connectivity between pharmacies and headquarters."

10. Amend, supplement, and abolish some forms in Appendix IV as follows:

a) Add Form No. 07/GDP after Form No. 06/GDP according to Form No. 03 in the Appendix attached to this Circular;

b) Add Form No. 08/GDP after Form No. 07/GDP according to Form No. 01 in the Appendix attached to this Circular;

c) Add Form No. 09/GDP after Form No. 08/GDP according to Form No. 02 in the Appendix attached to this Circular;

d) Replace Form No. 04/GDP according to Form No. 07 in the Appendix attached to this Circular;

đ) Replace Form No. 05/GDP according to Form No. 08 in the Appendix attached to this Circular;

e) Abolish Form No. 01/GDP and Form No. 02/GDP.

11. Replace some phrases used in the articles of this Circular as follows:

a) Replace the phrase "Wholesale vaccine establishments in the National Expanded Immunization Program at provincial and district levels" with the phrase "Wholesale vaccine establishments in the National Expanded Immunization Program at provincial level and commune-level agencies responsible for immunization" in Clause 4, Article 2 and Clause 3, Article 4;

b) Replace the phrase "application dossier" with the phrase "evaluation dossier" in Clause 6, Clause 7, Article 9 and Point b, Clause 3, Article 18;

c) Replace the phrase "Provincial Department of Health", "Department of Health" with the phrase "specialized health agency of the province" in this Circular. For the provisions 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, replace the phrase "Department of Health" with the phrase "Receiving Agency";

d) Replace the phrase "Business Registration Certificate for pharmaceutical activities" with the phrase "Business Registration Certificate for pharmaceuticals" in Appendix IV.

Article 3. Amending, supplementing, and abolishing some articles and annexes of Circular No. 36/2018/TT-BYT dated November 22, 2018, issued by the Minister of Health on Good Storage Practices for Medicines and Active Pharmaceutical Ingredients.

1. Amending and supplementing some clauses of Article 5 as follows:

a) Amending Clause 2 as follows:

“2. In cases where the entity requests to be granted both the Good Storage Practice (GSP) Certificate and the Certificate of Eligibility for Operating in the Pharmaceutical Sector, the entity must clearly state this request in the application form for the Certificate of Eligibility for Operating in the Pharmaceutical Sector. In cases where the entity has already been granted the Certificate of Eligibility for Operating in the Pharmaceutical Sector and wishes to obtain the GSP Certificate, the entity shall submit a written request for the GSP Certificate. The receiving authority will consider issuing the GSP Certificate based on the results of the most recent GSP assessment conducted prior to that.”

b) Supplementing Clause 3 following Clause 2 as follows:

“3. In cases where the entity engages in pharmaceutical activities but not for commercial purposes and requires a GSP Certificate, the entity shall submit a written request for the GSP Certificate along with technical documents according to the overall dossier template specified in Annex VI attached hereto. The receiving authority will review and issue the GSP Certificate based on the assessment results.”

2. Amend and supplement Clause 1 of Article 9 as follows:

“1. The periodic time frame for assessing the maintenance of compliance with GSP at storage facilities is three years, starting from the date of signing the evaluation report of the previous assessment (excluding any unscheduled assessments, inspections, or audits conducted by the Ministry of Health, provincial People's Committees (specialized agencies responsible for pharmaceutical affairs at the provincial level, hereinafter referred to as specialized health agencies of the province)).”

3. Amending and supplementing some clauses of Article 10 as follows:

a) Amend Clause 1 as follows:

“1. In cases where the GSP assessment report concludes that the storage facility complies with GSP at Level 1 as stipulated in Point a, Clause 3, Article 7 of this Circular:

Within ten days from the completion of the actual assessment at the facility, the receiving authority shall notify the facility of its continued compliance with GSP or grant the GSP Compliance Certificate according to Model No. 05 specified in Annex VII attached hereto if the facility requests such a certificate; the receiving authority shall update the status of GSP compliance of the facility on its electronic information website.”

b) Amending Point c of Clause 2 as follows:

“c) Within twenty days from the receipt of the corrective action report submitted by the storage facility, the receiving authority shall evaluate the results of the corrective actions taken by the storage facility and conclude on the status of GSP compliance of the storage facility as follows:

- If the corrective actions taken by the storage facility meet the requirements: The receiving authority shall notify the facility of its continued compliance with GSP or grant the GSP Compliance Certificate according to Model No. 05 specified in Annex VII attached hereto if the facility requests such a certificate; the receiving authority shall update the status of GSP compliance of the facility on its electronic information website.

- If the corrective actions taken by the storage facility do not meet the requirements: The receiving authority shall notify the facility of the necessary further corrective actions and submit a supplementary report. The extended period for further corrective actions and reporting is forty-five days from the date of the notification requesting such actions.”

4. Abolishing Clause 1 and Clause 3 of Article 21.

5. Supplementing some clauses in Article 22 as follows:

a) Supplementing Point d following Point c of Clause 3 of Article 22 as follows:

“d) Announcing the list of entities exporting, importing medicines and active pharmaceutical ingredients, wholesaling medicines and active pharmaceutical ingredients operating through e-commerce on the provincial specialized health agency’s electronic information website within five working days from the date of receipt of the notification from the entity;”

b) Supplementing Point đ following Point d of Clause 4 of Article 22 as follows:

“đ) Submitting a direct notification or sending via postal service or email to the provincial specialized health agency at the location of the business premises before commencing e-commerce activities according to Model No. 07 specified in Annex VII attached hereto, and before ceasing e-commerce activities according to Model No. 08 specified in Annex VII attached hereto.”

6. Amending some contents in Annex I as follows:

a) Amending the content "Sampling raw materials, processing sampling tools" at Subsection 5.3 of Clause 5 as follows:

“- In cases where there is a requirement for sampling raw materials, the sampling of raw materials and processing of sampling tools shall be carried out in the sampling area of the entity or performed under a contract with another entity having a sampling area that meets the requirements as specified in Subsection 5.6 of this Annex.”

b) Amending Subsection 5.6 of Clause 5 as follows:

“5.6. For entities with a sampling area, this area must be designed and equipped with systems meeting the regulations on sampling areas for raw materials for medicines as stipulated in the Circular of the Ministry of Health on Good Manufacturing Practices for Medicines and Active Pharmaceutical Ingredients.”

c) Amending Subsection 5.11 of Clause 5 as follows:

“5.11. There must be information technology equipment connected to the Internet and used to manage the storage activities of medicines and active pharmaceutical ingredients through software applications. There must be a mechanism for connecting information from the import, export, and distribution of medicines and active pharmaceutical ingredients to customers; ensuring traceability of the origin of medicines and active pharmaceutical ingredients; ensuring full extraction of data when requested by management authorities; and linking and updating full data with the drug information system as guided by the Ministry of Health.”

d) Amending Subsection 8.4 of Clause 8 as follows:

“8.4. Foreign-invested pharmaceutical businesses may only export and deliver goods to wholesale medicine and active pharmaceutical ingredient businesses at their own storage facilities, transporting from customs warehouses to their own warehouses or between their own warehouses, and conducting delivery and transportation activities in accordance with Point d, đ, e of Clause 3, Article 53a of the Medicine Law. For radioactive medicines with a shelf life of thirty days or less, the entity may follow the provisions specified in Subsection 9.11 of Clause 9 of Annex I.”

đ) Amending Subsection 9.11 of Clause 9 as follows:

"9.11. There must be procedures for importing and exporting goods, taking into account the nature of the drugs, drug ingredients, and necessary preventive measures. In cases where radioactive drugs have a shelf life of 30 days or less: The entity may transfer drugs from the import port to the place of use; the procedures for importing and exporting goods must clearly specify the steps to be taken, the responsibilities of relevant personnel, and the documentation for this case to ensure the management of the import and export process and control over radioactive drugs."

e) Amend Section 9.18 of Clause 9 as follows:

"9.18. There must be procedures specifying the frequency and methods of cleaning storage areas and storage zones; procedures for cleaning sampling areas for drugs and drug ingredients (for entities with sampling areas)."

7. Amend some contents in Appendix III as follows:

a) Amend the content "Sampling raw materials, handling sampling equipment" at Section 2.3 of Clause 2 as follows:

"- In cases where there is a requirement to sample raw materials, the sampling of raw materials and handling of sampling equipment shall be carried out in the sampling area of the entity or performed under a contract with another entity that has a raw material sampling area meeting the requirements set forth in Section 2.6 of this appendix."

b) Amend Section 2.6 of Clause 2 as follows:

"2.6. For entities with a raw material sampling area, this area must be designed and equipped with systems complying with the regulations on raw material sampling areas for drugs as stipulated in the Circular of the Ministry of Health on Good Manufacturing Practices for Drugs and Drug Ingredients."

c) Amend Section 2.12 as follows:

"2.12. There must be information technology equipment connected to the Internet and the management of drug and drug ingredient storage activities through application software. There must be a mechanism for connecting information from drug and drug ingredient import, export, and distribution activities to customers; ensuring traceability of drug and drug ingredient origins; ensuring full extraction of all data when requested by regulatory authorities; linking and updating full data with the pharmaceutical information system according to the guidance of the Ministry of Health."

c) Repeal Section 5.4 of Clause 5;

d) Amend Section 6.18 of Clause 6 as follows:

"6.18. There must be procedures specifying the frequency and methods of cleaning storage areas and storage zones; procedures for cleaning sampling areas for drugs and drug ingredients (for entities with sampling areas)."

8. Amend and supplement some forms in Appendix VII as follows:

a) Replace Form No. 01 with Form No. 04 in the Appendix issued together with this Circular;

b) Replace Form No. 05 with Form No. 06 in the Appendix issued together with this Circular;

c) Supplement Form No. 07 after Form No. 06 based on Form No. 01 in the Appendix issued pursuant to this Circular;

d) Supplement Form No. 08 after Form No. 07 based on Form No. 02 in the Appendix issued together with this Circular.

9. Amend some phrases used in Articles and Appendices of the Circular as follows:

a) Amend the phrase "certificate of eligibility for drug business" to "certificate of eligibility for pharmaceutical business" in Appendix VI of the Circular;

b) Amend the phrase "vaccine storage facility in the national expanded immunization program at the district level" to "immunization management agency at the commune level";

c) Amend the phrase "Department of Health of the province", "Department of Health" to "specialized health agency of the province";

d) Repeal the phrase "(hereinafter referred to as the Department of Health)".

Article 4. Amend and abolish certain Articles and Clauses of Circulars amending and supplementing certain Articles of Circular No. 02/2018/TT-BYT dated January 22, 2018 of the Minister of Health on Good Pharmacy Practice for Retail Drug Outlets, and Circular No. 03/2018/TT-BYT dated February 9, 2018 of the Minister of Health on Good Distribution Practice for Drugs and Active Pharmaceutical Ingredients.

1. Amend and abolish certain Articles of Circular No. 12/2020/TT-BYT dated June 22, 2020 of the Minister of Health amending and supplementing certain Articles of Circular No. 02/2018/TT-BYT dated January 22, 2018 of the Minister of Health on Good Pharmacy Practice for Retail Drug Outlets as follows:

a) Abolish Clause 6 of Article 1;

b) Amend the phrase "application for periodic evaluation dossier" to "periodic evaluation dossier" in Clause 8 and Clause 9 of Article 1;

c) Amend the phrase "Department of Health" to "specialized health agency of the province" in Clause 10 of Article 1.

2. Amend and abolish certain Articles of Circular No. 09/2020/TT-BYT dated June 10, 2020 of the Minister of Health amending and supplementing certain Articles of Circular No. 03/2018/TT-BYT dated February 9, 2018 of the Minister of Health on Good Distribution Practice for Drugs and Active Pharmaceutical Ingredients as follows:

a) Abolish Clause 6 and Clause 11 of Article 1;

b) Amend the phrase "application for periodic evaluation dossier" to "periodic evaluation dossier" in Clause 7 of Article 1;

c) Amend the phrase "Department of Health" to "specialized health agency of the province" in Clause 10 of Article 1.

Article 5. Effective Date

1. This Circular takes effect from July 1, 2025.

2. Regulations on drug business establishments linking their systems with the national drug information system and updating data fully according to the Ministry of Health's guidelines shall be implemented from January 1, 2026.

Article 6. Transitional Provisions

Dossiers submitted before this Circular takes effect shall continue to be processed according to the regulations at the time of submission or apply the provisions of this Circular from July 1, 2025, in a manner that facilitates and simplifies administrative procedures for enterprises, organizations, and individuals.

Article 7. Responsibility for Implementation

1. The Drug Administration Department shall be responsible for:

a) Taking the lead and coordinating with relevant units to organize the dissemination of this Circular;

b) Serving as the focal point and coordinating with relevant units to guide the implementation of this Circular to specialized health agencies of provinces, health sectors, and drug business establishments within its assigned functions and tasks;

c) Implementing inspections of compliance with the provisions of this Circular and handling or recommending the handling of violations within its authority.

2. The Traditional Medicine and Drug Administration Department shall be responsible for:

a) Serving as the focal point and coordinating with relevant units to guide the implementation of this Circular to specialized health agencies of provinces, health sectors, and traditional medicine distributors and herbal material suppliers within its assigned functions and tasks;

b) Implementing inspections of compliance with the provisions of this Circular and handling or recommending the handling of violations within its authority.

3. Provincial People's Committees shall be responsible for directing subordinate agencies to inspect compliance with good practice principles and standards of drug business establishments in their jurisdiction and instructing specialized health agencies of provinces to perform the following tasks:

a) Coordinating with relevant units to organize the dissemination of this Circular and guide its implementation in their jurisdictions;

b) Implementing inspections of compliance with the provisions of this Circular and handling violations within their authority.

4. Drug business establishments shall be responsible for:

a) Organizing research and implementation of the provisions of this Circular;

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

c) Conducting drug and active pharmaceutical ingredient business activities within the scope permitted based on compliance with legal regulations.

During the implementation process, if there are difficulties or obstacles, enterprises, organizations, and individuals are advised to report to the Ministry of Health (Drug Administration Department) for consideration and resolution./.