Circular No. 11/2025/TT-BYT dated May 16, 2025 on amendments to Circular No. 02/2018/TT-BYT on Good Pharmacy Practices, Circular No. 03/2018/TT-BYT on Good Distribution Practices for medicinal products and medicinal materials, Circular No. 36/2018/TT-BYT on Good Storage Practices for medicinal products and medicinal materials
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THE MINISTRY OF HEALTH |
SOCIALIST REPUBLIC OF VIETNAM |
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No. 11/2025/TT-BYT |
Hanoi, May 16, 2025 |
CIRCULAR
AMENDMENTS TO SOME 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 FOR MEDICINAL PRODUCTS AND MEDICINAL MATERIALS, CIRCULAR NO. 36/2018/TT-BYT DATED NOVEMBER 22, 2018 OF THE MINISTER OF HEALTH ON GOOD STORAGE PRACTICES FOR MEDICINAL PRODUCTS AND MEDICINAL MATERIALS
Pursuant to the Law on Pharmacy dated April 06, 2016;
Pursuant to the Law on amendments to some 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 request of the Director General of the Drug Administration of Vietnam, the Director General of the Traditional Medicine Administration of Vietnam;
The Minister of Health hereby promulgates a Circular on amendments to some 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 for medicinal products and medicinal materials, Circular No. 36/2018/TT-BYT dated November 22, 2018 of the Minister of Health on Good Storage Practices for medicinal products and medicinal materials.
Article 1. Amending, supplementing and repealing some 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. Clause 1 of Article 6 is amended as follows:
“1. Receipt of application:
The pharmacy shall submit an application for inspection prescribed in Article 5 herein and pay assessment fees in accordance with the Ministry of Finance’s regulations on fees for processing of applications for certification of pharmacy standards, to the provincial People’s Committee (specialized authority assigned by the province to be in charge of pharmacy, hereinafter referred to as “the provincial specialized health authority”).
2. Some clauses of Article 9 are amended and repealed as follows:
a) Clause 2 is amended as follows:
“2. Every provincial specialized health authority shall, in November every year, publish the plan for periodic inspection of pharmacies’ maintenance of compliance with GPP requirements in the following year on its website as prescribed in clause 1 of this Article”;
b) Clause 3 is amended as follows:
“3. The pharmacy must, at least 30 days prior to the date of periodic inspection, submit a report on pharmacies’ maintenance of compliance with GPP requirements as prescribed in point c clause 7 of this Article to the provincial specialized health authority”;
c) Clause 4 is repealed;
d) Point a of clause 7 is amended as follows:
“a) An application form for issuance of GPP Certificate (if the pharmacy so requests)”.
3. Some clauses of Article 10 are amended as follows:
a) Clause 1 is amended as follows:
“1. If the inspection report indicates that the pharmacy complies with GPP requirements as prescribed in point a clause 3 Article 7 herein:
Within 10 days from the completion of the site inspection at the pharmacy premises and signing of the inspection report, the provincial specialized health authority shall issue a written notification of maintenance of compliance with GPP requirements by the pharmacy or a Certificate of GPP compliance according to the Form No. 03/GPP specified in the Appendix III to this Circular if the pharmacy applies for issuance of the Certificate of GPP compliance; the provincial specialized health authority shall update the pharmacy’s GPP compliance status on its website”;
b) Point c of clause 2 is amended as follows:
“c) Within 20 days from the receipt of the corrective action report accompanied by evidences thereof (such as documents, photographs, videos and certificates), the provincial specialized health authority shall evaluate results of correction actions taken by the pharmacy and conclude its GPP compliance status as follows:
- If results of correction actions make the pharmacy comply with GPP requirements, the provincial specialized health authority shall issue a written notification of maintenance of compliance with GPP requirements by the pharmacy or a Certificate of GPP compliance according to the Form No. 03/GPP specified in the Appendix III to this Circular if the applies for issuance of the Certificate of GPP compliance; the provincial specialized health authority shall update the pharmacy’s GPP compliance status on its website;
- If results of corrective actions show that the pharmacy still fails to comply with GPP requirements, the provincial specialized health authority shall continue requesting the pharmacy in writing to take more corrective actions and submit an additional report. The pharmacy shall have 45 days from the date of receipt of the written request to complete corrective actions and send a report thereon”.
4. Article 15a is added after Article 15 is amended as follows:
“Article 15a. Terms of reference
In the cases where any of the legislative documents and regulations referred to in this Circular is changed, supplemented or replaced, the new legislative documents shall apply”.
5. Article 6 is amended as follows:
“Article 16. Transitional clause
If a pharmacy has been granted the Certificate of Satisfaction of Conditions for Pharmaceutical Business with the scope of retail of medicinal products, it must submit a report on maintenance of compliance with GPP requirements as prescribed in clause 3 Article 9 of this Circular”.
6. Some clauses of Article 17 are amended as follows:
a) Point c clause 2 of Article 17 is amended as follows:
“c) Publish on the website of the provincial specialized health authority the list of pharmacies in its province which have been granted Certificates of Satisfaction of Conditions for Pharmaceutical Business, information about status of Certificates of Satisfaction of Conditions for Pharmaceutical Business, GPP compliance status and other information as prescribed in clause 4 Article 8 of this Circular; publish on the website of the provincial specialized health authority the list of pharmacies which conduct e-commerce activities within 05 working days from the date of receiving the pharmacy’s written notification”;
b) Point d is added after point c clause 3 of Article 17 as follows:
“d) Send a written notification in person or by post or email to the specialized health authority of the province where its business location exists before conduct of e-commerce activities according to the Form No. 05/GPP specified in the Appendix III to this Circular and before termination of e-commerce activities according to Form No. 06/GPP specified in the Appendix III to this Circular”.
7. Point c clause 4 Section II in the Appendix I-1a is amended as follows:
“c) All drugstores are required to use IT equipment connected to the internet and applications to manage their purchase and sale of medicinal products; ensure the control of origin, prices, and sources of medicinal products purchased and sold; ensure traceability of medicinal products; fully provide the above information at the request of competent authorities; fully connect and update data with the pharmacy information system as instructed by the Ministry of Health”.
8. Points d and dd are added after point c of clause 2 section III in the Appendix I-1a and point d after point c of clause 2 section III in the Appendix I-1b as follows:
“d) Sale of medicinal products by e-commerce method:
- Every drugstore that sells medicinal products by e-commerce method must provide online advice and guidance through equipment and IT on the contents specified in points a and b of this clause, instructions for storage of medicinal products and may only sell medicinal products after providing advice and guidance to buyers of medicinal products. The online advice and guidance must be provided by audio or video conversations or messages other data messages; the drugstore must keep and record at least the buyers' contact information and a summary of advice and guidance provided in the sales software as evidences. The drugstore must keep evidences of online advice and guidance for at least 24 months from the date of provision;
- Packaging for transportation of medicinal products must contain the following information: Name and address of the medicinal product buyer, name and address of the pharmacy, medicinal product storage conditions, and maximum time limit for delivery. The individuals responsible for the transportation of medicinal products shall be informed about all relevant conditions for storage and transportation and adhere to these conditions throughout transportation;
- Medicinal products must be packaged, stored and transported in an appropriate way to protect integrity of the products and information thereof; prevent the contamination and maintain storage conditions throughout the transportation;
dd) When selling prescription drugs under electronic prescriptions, the pharmacy must update electronic prescription codes to the system using the Ministry of Health's electronic prescription data to establish a connection to the Ministry of Health's system; sell medicinal products according to prescriptions, ensure that the quantity of medicinal products sold does not exceed that stated on the prescriptions, and shall not sell medicinal products under expired prescriptions”.
9. Point c clause 4 Section II in the Appendix I-1a is amended as follows:
“c) All drugstores are required to use IT equipment connected to the internet and applications to manage their purchase and sale of medicinal products; ensure the control of origin, prices, and sources of medicinal products purchased and sold; ensure traceability of medicinal products; fully provide the above information at the request of competent authorities; fully connect and update data with the pharmacy information system as instructed by the Ministry of Health”.
10. The “content” 5.1.1 in the Appendix II-2a is amended as follows:
“* The drugstore has adequate physical original copies or certified true copies of legal documents (business registration certificate or establishment decision for a drugstore under a public medical establishment), pharmacy practicing certificate of the chief pharmacist of the drugstore, Certificate of Satisfaction of Conditions for Pharmaceutical Business (for an operating drugstore)”.
11. The “content” 5.1.1 in the Appendix II-2b is amended as follows:
“* The dispensary has adequate physical original copies or certified true copies of legal documents (business registration certificate or establishment decision for a dispensary under a public medical establishment), pharmacy practicing certificate of the chief pharmacist of the dispensary, Certificate of Satisfaction of Conditions for Pharmaceutical Business (for an operating dispensary)”.
12. The second paragraph of section 5.3.2 in the Appendix II-2a and section 5.3.2 in the Appendix II-2b are amended as follows:
“(*) The drugstore has used IT equipment connected to the internet and applications to manage its purchase and sale of medicinal products; has ensured the control of origin, prices, and sources of medicinal products purchased and sold; has ensured traceability of medicinal products; has archived patients' prescriptions (physical or electronic). The drugstore has fully provided the above information at the request of competent authorities; has fully connected and updated data with the pharmacy information system as instructed by the Ministry of Health”.
13. The content: “The drugstore has adopted measures for monitoring the sale of prescription drugs” in section 7.6 in the Appendix II-2b is amended as follows:
“The drugstore has adopted measures for monitoring the sale of prescription drugs, updated electronic prescription codes to the system using the Ministry of Health's electronic prescription data when selling prescription drugs under electronic prescriptions to establish a connection to the Ministry of Health's system; has sold medicinal products according to prescriptions, ensured that the quantity of medicinal products sold does not exceed that stated on the prescriptions, and not sold medicinal products under expired prescriptions”.
14. Forms in the Appendix III are amended and repealed as follows:
a) Form No. 04/GPP provided in Form No. 05 in the Appendix to this Circular is added after Form No. 03/GPP;
b) Form No. 05/GPP provided in Form No. 01 in the Appendix to this Circular is added after Form No. 04/GPP;
c) Form No. 06/GPP provided in Form No. 02 in the Appendix to this Circular is added after Form No. 05/GPP;
d) Form No. 01/GPP is repealed.
15. Some phrases in articles and appendices of the Circular are replaced as follows:
a) The phrase “Sở Y tế” (“provincial Department of Health”) is replaced with the phrase “cơ quan chuyên môn về y tế của tỉnh” (“provincial specialized health authority”);
b) The phrase “người phụ trách chuyên môn” (“pharmacist”) or “người quản lý chuyên môn” (“chief pharmacist”) is replaced with the phrase “Người chịu trách nhiệm chuyên môn về dược của cơ sở” (“Chief pharmacist of the pharmacy”)”;
c) The phrase “thuốc quản lý đặc biệt” (“medicinal products under special management”) is replaced with the phrase “thuốc phải kiểm soát đặc biệt” (“medicinal products under special control”);
d) The phrase “thuốc hướng tâm thần” is replaced with the phrase “thuốc hướng thần” (“psychotropic drugs”);
dd) The phrase “dụng cụ y tế” (“medical tools”) is replaced with the phrase “thiết bị y tế” (“medical equipment”);
e) The phrase “giấy chứng nhận đủ điều kiện kinh doanh thuốc” (“Certificate of Satisfaction of Conditions for Medicinal Product Business”) is replaced with the phrase “giấy chứng nhận đủ điều kiện kinh doanh dược” (“Certificate of Satisfaction of Conditions for Pharmaceutical Business”);
g) The phrase “hồ sơ đề nghị đánh giá định kỳ” (“application for periodic inspection”) in clause 6 and clause 7 Article 9 of the Circular is replaced with the phrase “hồ sơ đánh giá định kỳ” (“dossier on periodic inspection”).
Article 2. Amending, supplementing and repealing some Articles and Appendices of the Circular No. 03/2018/TT-BYT dated February 09, 2018 of the Minister of Health on Good Distribution Practices for medicinal products and medicinal materials
1. Point a clause 2 of Article 5 is amended as follows:
“a. Legal documents on the establishment of the distributor;”.
2. Clause 1 of Article 6 is amended as follows:
“1. Receipt of application:
The distributor shall submit 01 application prescribed in Article 5 of this Circular and pay assessment fees according to regulations of the Minister of Finance on fees for assessment of GDP for medicinal products and medicinal materials to the provincial People’s Committee (specialized authority assigned by the province to be in charge of pharmacy, hereinafter referred to as “the provincial specialized health authority”). Where the distributor is a facility organizing the pharmacy chain, it shall submit an application and pay assessment fees to the Drug Administration of Vietnam.”.
3. The phrase “Mẫu số 06” (“Form No. 06”) in clause 1, point c clause 2 of Article 8 is changed to “Mẫu số 07” (“Form No. 07”).
4. Some clauses of Article 9 are amended, supplemented and repealed as follows:
a) Clause 2 is amended as follows:
“2. In November every year, each provincial specialized health authority shall publish on its website the List of medicinal product and medicinal material distributors that are due for periodic inspection of maintenance of compliance with GDP requirements in the succeeding year as prescribed in clause 1 of this Article and the Drug Administration of Vietnam shall publish on its website the List of medicinal product and medicinal material distributors in the case where the distributors are facilities organizing the pharmacy chain;”;
b) Clause 3 is amended as follows:
“3. The medicinal product and medicinal material distributor must, at least 30 days prior to the date of periodic inspection, submit a report on maintenance of compliance with GDP requirements as prescribed in point c clause 7 of this Article to the receiving authority;”;
c) Clause 4 is repealed;
d) Point a of clause 7 is amended as follows:
“a) An application form for issuance of GDP Certificate (if the distributor so requests)”.
5. Some clauses of Article 10 are amended as follows:
a) Clause 1 is amended as follows:
“1. In case the GDP inspection record concludes that the distributor is in GDP degree 1 according to point a clause 2 Article 7 of this Circular:
Within 10 days from the end of the site inspection at the medicinal product and medicinal material distributor and the signing of the inspection record, the receiving authority shall issue a written notification of maintenance of compliance with GDP requirements by the distributor or a Certificate of GDP compliance according to the Form No. 07 specified in the Appendix IV to this Circular if the distributor applies for the Certificate of GDP compliance; the receiving authority shall update the GDP compliance status of the distributor on its website.”;
b) Point c of clause 2 is amended as follows:
“c) Within 20 days from the receipt of the corrective action report accompanied by evidences thereof (such as documents, photographs, videos and certificates), the receiving authority shall evaluate results of correction actions taken by the medicinal product and medicinal material distributor and conclude its GDP compliance status as follows:
- If results of correction actions make the pharmacy comply with GDP requirements, the receiving authority shall issue a written notification of maintenance of compliance with GDP requirements by the distributor or a Certificate of GDP compliance according to the Form No. 07 specified in the Appendix IV to this Circular if the distributor applies the Certificate of GDP compliance; the receiving authority shall update the GDP compliance status of the distributor on its website;
- If results of corrective actions show that the medicinal product and medicinal material distributor still fails to comply with GDP requirements, the receiving authority shall continue requesting the distributor in writing to take more corrective actions and submit an additional report. The distributor shall have 45 days from the date of receipt of the written request to complete corrective actions and send a report thereon.”.
6. Some clauses of Article 13 are amended as follows:
a) Clause 1 is amended as follows:
“1. Members of an inspectorate include:
Head, secretary and other members decided by the head of the receiving authority. The number of members shall not exceed 05.”.
b) Point a of clause 2 is amended as follows:
a) He/she must be a public official or public employee of a provincial specialized health authority or public official, public employee or official working under an employment contract in affiliates of the provincial specialized health authority; For an inspectorate conducting inspection of the distributor organizing the pharmacy chain, officials of the inspectorate are public officials and public employees of the Drug Administration of Vietnam and representatives of the specialized health authority of the province where the distributor’s head office is located;”.
7. Some clauses of Article 17 are amended as follows:
a) Clause 1 is repealed;
b) Clause 2 is amended as follows:
“2. Regarding a distributor that has been issued with the indefinite term Certificate of Satisfaction of Conditions for Pharmaceutical Business, upon the expiry of the certificate of GDP compliance, the distributor shall submit a report on maintenance of compliance with GDP requirements as prescribed in clause 3 Article 9 of this Circular.”;
c) Clause 3 is repealed.
8. Some clauses of Article 18 are amended as follows:
a) Point c clause 3 of Article 18 is amended as follows:
“c) Publish on the website of the provincial specialized health authority the list of wholesalers of medicinal products and medicinal materials in its province which have been granted Certificates of Satisfaction of Conditions for Pharmaceutical Business, information about GDP compliance status of Certificates of eligibility for pharmacy business and GPP Certificates, and other information as prescribed in clause 4 Article 8 of this Circular; publish on the website of the provincial specialized health authority the list of wholesalers of medicinal products and medicinal materials which conduct e-commerce activities within 05 working days from the date of receiving the wholesaler’s written notification”;
b) Point d is added after point c clause 4 of Article 18 as follows:
“d) Send a written notification to the specialized health authority of the province where its business location exists before conduct of e-commerce activities according to the Form No. 08 specified in the Appendix IV to this Circular and before termination of e-commerce activities according to Form No. 09/GPP specified in the Appendix IV to this Circular. Send the written notification in person or by post or email to the provincial specialized health authority. The facility organizing the pharmacy chain shall notify the provincial specialized health authority of the list of pharmacies involved in e-commerce activities in the province.”.
9. Some sections of Appendix I are amended as follows:
a) Section 14.11 in clause 14 is amended as follows:
“14.11. All distributors must use IT equipment connected to the internet and applications to manage their distribution of medicinal products and medicinal materials; ensure the control of origin, prices, and sources of medicinal products purchased and sold; ensure traceability of medicinal products and medicinal materials; fully provide the above information at the request of competent authorities; fully connect and update data with the pharmacy information system as instructed by the Ministry of Health.”;
b) Section 14.16 is added to clause 14 as follows:
“14.16. For a facility organizing the pharmacy chain, all activities related to the supply, circulation, storage and preservation of medicinal products, and data related to medicinal product buyers at all pharmacies in the chain must be managed by the same process and controlled by the chief pharmacists of the facility, ensuring the ability to track production batch numbers, expiry dates, export, import and inventory history, information of medicinal product buyers (complying with confidentiality) and seamless connection between pharmacies and headquarters.”.
10. Some forms in the Appendix IV are amended, supplemented and repealed as follows:
a) Form No. 07/GDP provided in Form No. 03 in the Appendix to this Circular is added after Form No. 06/GDP;
b) Form No. 08/GDP provided in Form No. 01 in the Appendix to this Circular is added after Form No. 07/GDP;
c) Form No. 09/GDP provided in Form No. 02 in the Appendix to this Circular is added after Form No. 08/GDP;
d) Form No. 04/GDP is replaced with the Form No. 07 in the Appendix to this Circular;
dd) Form No. 05/GDP is replaced with the Form No. 08 in the Appendix to this Circular;
e) Form No. 01/GDP and Form No. 02/GDP are repealed.
11. Some phrases in articles of the Circular are replaced as follows:
a) The phrase “Cơ sở phân phối vắc xin trong Chương trình Tiêm chủng mở rộng quốc gia ở tuyến tỉnh và tuyến huyện” (“distributors of vaccines that are part of the National Expanded Program on Immunization of provinces or districts”) in clause 4 of Article 2 and clause 3 of Article 4 is replaced with the phrase “Cơ sở phân phối vắc xin trong Chương trình Tiêm chủng mở rộng quốc gia ở cấp tỉnh và cơ quan được giao quản lý về tiêm chủng cấp xã” (“distributors of vaccines that are part of the National Expanded Program on Immunization of provinces and communal-level agencies assigned to manage immunization”);
b) The phrase “hồ sơ đề nghị đánh giá” (“application for inspection”) in clause 6 and clause 7 Article 9 and point b clause 3 Article 18 of the Circular is replaced with the phrase “hồ sơ đánh giá” (“periodic dossier”);
c) The phrase “Sở Y tế tỉnh, thành phố trực thuộc Trung ương” (“Departments of Health of provinces and central-affiliated cities”), “Sở Y tế” (“Department of Health”) in the Circular is replaced with the phrase “cơ quan chuyên môn về y tế của tỉnh” (“provincial specialized health authority”). For the regulations set out under clause 3 of Article 6, Article 7, Article 8, points a, b and d clause 2, clause 3 and clause 4 of Article 10, Article 11 and Article 12, the phrase “Sở Y tế” (“Department of Health”) is changed to the phrase “Cơ quan tiếp nhận” (“Receiving authority”);
d) The phrase “giấy chứng nhận đủ điều kiện kinh doanh thuốc” (Certificate of Satisfaction of Conditions for Medicinal Product Business”) in the Appendix IV is replaced with the phrase “giấy chứng nhận đủ điều kiện kinh doanh dược” (“Certificate of Satisfaction of Conditions for Pharmaceutical Business”).
Article 2. Amending, supplementing and repealing some Articles and Appendices of the Circular No. 36/2018/TT-BYT dated November 22, 2018 of the Minister of Health on Good Storage Practices for medicinal products and medicinal materials
1. Some clauses of Article 5 are amended as follows:
a) Clause 2 is amended as follows:
“2. If a facility applies for both certificate of GSP compliance and Certificate of Satisfaction of Conditions for Pharmaceutical Business, this content must be clearly specified in its application form for Certificate of Satisfaction of Conditions for Pharmaceutical Business. If a facility granted the Certificate of Satisfaction of Conditions for Pharmaceutical Business wishes to apply for issuance of the Certificate of GSP compliance, it shall prepare an application form for issuance of the Certificate of GSP compliance. The receiving authority shall consider the issuance of the Certificate of GSP compliance based on the result of the latest GSP inspection.”;
b) Clause 3 is added after clause 2 as follows:
“3. If a facility is involved in pharmaceutical activities for non-commercial purposes wishes to obtain a Certificate of GSP compliance, the facility must submit an application form for issuance of Certificate of GSP compliance accompanied by technical documents in accordance with guidelines for the site master file provided in the Appendix VI to this Circular. The receiving authority shall consider GSP inspection and issuance of the Certificate of GSP compliance.”.
2. Clause 1 of Article 9 is amended as follows:
“1. GSP compliance by a storage facility shall be periodically inspected every 03 years from the date of signing the previous inspection record (except unexpected inspections or audits by the Ministry of Health or the Provincial People’s Committee (specialized agency assigned to be in charge of pharmaceutical expertise, hereinafter referred to as “provincial specialized health authority)”..
3. Some clauses of Article 10 are amended as follows:
a) Clause 1 is amended as follows:
“1. In case the GSP inspection record concludes that the medicinal product and medicinal material storage facility is in GSP degree 1 according to point a clause 3 Article 7 of this Circular:
Within 10 days from the end of the site inspection at the facility, the receiving authority shall issue a written notification of maintenance of compliance with GSP requirements by the facility or a Certificate of GSP compliance according to the Form No. 05 specified in the Appendix VII to this Circular if the distributor applies for issuance of the Certificate of GSP compliance; the receiving authority shall update the GSP compliance status of the facility on its website.”;
b) Point c of clause 2 is amended as follows:
“c) Within 20 days from the receipt of the corrective action report of the material product and medicinal material storage facility, the receiving authority shall evaluate results of correction actions taken by the material product and medicinal material storage facility and conclude the its GSP compliance status as follows:
- If results of correction actions make the storage facility comply with GSP requirements, the receiving authority shall issue a written notification of maintenance of compliance with GSP requirements by the facility or a Certificate of GSP compliance according to the Form No. 05 specified in the Appendix VII to this Circular if the distributor applies for issuance of the Certificate of GSP compliance; the receiving authority shall update the GSP compliance status of the facility on its website.
- If results of corrective actions show that the medicinal product and material distributor still fails to comply with GSP requirements, the receiving authority shall continue requesting the facility in writing to take more corrective actions and submit an additional report. The facility shall have 45 days from the date of receipt of the written request to complete corrective actions and send a report thereon.”.
4. Clause 1 and clause 3 of Article 21 are repealed.
5. Some clauses are added to Article 22 as follows:
a) Point d is added after point c clause 3 of Article 22 as follows:
“d) Publish the List of exporters and importers of medicinal products and medicinal materials and wholesalers of medicinal products and medicinal materials involved in e-commerce activities in the province on website of the provincial specialized health authority within 05 working days from the date of receiving the facility’s written notification;”;
b) Point dd is added after point d clause 4 of Article 22 as follows:
“dd) Send a written notification in person or by post or email to the specialized health authority of the province where its business location exists before conduct of e-commerce activities according to the Form No. 07 specified in the Appendix VII to this Circular and before termination of e-commerce activities according to Form No. 08 specified in the Appendix VII to this Circular.”.
6. Some contents in Appendix I are amended as follows:
a) The content “Lấy mẫu nguyên liệu, xử lý dụng cụ lấy mẫu” (“Sample collection, handling of sampling tools”) in section 5.3 of clause 5 is amended as follows:
“-In case the material sampling is requested, the sampling of materials and handling of sampling tools shall be carried out at the facility's sampling area or under a contract with another facility whose material sampling area meets the requirements in section 5.6 of this Appendix.”.
b) Section 5.6 in clause 5 is amended as follows:
“5.6. Regarding a facility having a material sampling area, this area must be designed and have a system of equipment satisfying the regulations on material sampling areas specified in the Circular of the Ministry of Health on Good Storage Practices for medicinal products and medicinal materials.”;
c) Section 5.11 in clause 5 is amended as follows:
“5.11. There should be IT equipment connected to the internet and applications to manage the storage of medicinal products and medicinal materials. Mechanisms should exist to allow for transfer of information, including information about receipt, release and distribution of medicinal products and medicinal materials to a customer; ensure the traceability of medicinal products and medicinal materials; fully provide the above information at the request of competent authorities; fully connect and update data with the pharmacy information system as instructed by the Ministry of Health.”;
d) Section 8.4 in clause 8 is amended as follows:
“8.4. A foreign-invested pharmacy business establishment is only allowed to dispatch and deliver medicinal products and medicinal materials to a wholesaler of medicinal products and medicinal materials at the medicinal product and medicinal material warehouse of the storage facility, transport medicinal products and medicinal materials from a customs warehouse to warehouse of the facility or between warehouses of the storage facility, deliver and transport medicinal products and medicinal materials as prescribed in points d, d and e clause 3 Article 53a of the Law on Pharmacy. In the case of radioactive drugs with a shelf life of 30 days or less, the facility shall comply with the provisions in section 9.11 clause 9 of Appendix I.”;
dd) Section 9.11 in clause 9 is amended as follows:
“9.11. Written procedures for the receipt and dispatch of medicinal products and medicinal materials should be established. Such procedures should take into account the nature of the medicinal products and medicinal materials as well as any special precautions to be observed. In the case of radioactive drugs with a shelf life of 30 days or less, the facility may transport the drugs from the port of import to the place of use; the receipt and dispatch procedures must clearly specify the steps to be taken, responsibilities of relevant personnel and files this case to facilitate the management of the receipt and dispatch process and the control of radioactive drugs.”;
e) Section 9.18 in clause 9 is amended as follows:
“9.18. A written sanitation program should be available indicating the frequency of cleaning and the methods to be used to clean the warehouses and storage areas; medicinal product and medicinal material sampling areas (for facilities having sampling areas).”.
7. Some contents in Appendix III are amended as follows:
a) The content “Lấy mẫu nguyên liệu, xử lý dụng cụ lấy mẫu” (“Sample collection, handling of sampling tools”) in section 2.3 of clause 2 is amended as follows:
“-In case the material sampling is requested, the sampling of materials and handling of sampling tools shall be carried out at the facility's sampling area or under a contract with another facility whose material sampling area meets the requirements in section 2.6 of this Appendix.”;
b) Section 2.6 in clause 2 is amended as follows:
“2.6. Regarding a facility having a material sampling area, this area must be designed and have a system of equipment satisfying the regulations on material sampling areas specified in the Circular of the Ministry of Health on Good Storage Practices for medicinal products and medicinal materials.”;
c) Section 2.12 is amended as follows:
“2.12. There should be IT equipment connected to the internet and applications to manage the storage of medicinal products and medicinal materials. Mechanisms should exist to allow for transfer of information, including information about receipt, release and distribution of medicinal products and medicinal materials to a customer; ensure the traceability of medicinal products and medicinal materials; fully provide the above information at the request of competent authorities; fully connect and update data with the pharmacy information system as instructed by the Ministry of Health.”;
c) Section 5.4 of clause 5 is repealed;
d) Section 6.18 in clause 6 is amended as follows:
“6.18. A written sanitation program should be available indicating the frequency of cleaning and the methods to be used to clean the warehouses and storage areas; medicinal product and medicinal material sampling areas (for facilities having sampling areas.”.
8. Some forms in the Appendix VII are amended and supplemented as follows:
a) Form No. 01 is replaced with the Form No. 04 in the Appendix to this Circular;
b) Form No. 05 is replaced with the Form No. 06 in the Appendix to this Circular;
c) Form No. 07 provided in Form No. 01 in the Appendix to this Circular is added after Form No. 06;
d) Form No. 08 provided in Form No. 02 in the Appendix to this Circular is added after Form No. 07.
9. Some phrases in articles and appendices of the Circular are amended as follows:
a) The phrase “giấy chứng nhận đủ điều kiện kinh doanh thuốc” (Certificate of Satisfaction of Conditions for Medicinal Product Business”) in the Appendix VI of the Circular is replaced with the phrase “giấy chứng nhận đủ điều kiện kinh doanh dược” (“Certificate of Satisfaction of Conditions for Pharmaceutical Business”);
b) The phrase “Cơ sở bảo quản vắc xin trong Chương trình Tiêm chủng mở rộng quốc gia tuyến huyện” (“storage facilities for storage of vaccines under the National Expanded Program on Immunization in districts”) is replaced with the phrase “cơ quan được giao quản lý về tiêm chủng cấp xã”” (“communal-level agencies assigned to manage immunization”)”;
c) The phrase “Sở Y tế tỉnh, thành phố trực thuộc Trung ương” (“Departments of Health of provinces and central-affiliated cities”), “Sở Y tế” (“Department of Health”) is replaced with the phrase “cơ quan chuyên môn về y tế của tỉnh” (“provincial specialized health authority”);
d) The phrase “(sau đây được gọi tắt là Sở Y tế) (“hereinafter referred to as “Department of Health”) is repealed.
Article 4. Amending and repealing some articles and clauses of circulars on amendments to some 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 for medicinal products and medicinal materials
1. Some Articles of the Circular No. 12/2020/TT-BYT dated June 22, 2020 of the Minister of Health on amendments to some Articles of the Circular No. 02/2018/TT-BYT dated January 22, 2018 of the Minister of Health on Good Pharmacy Practices are amended and repealed as follows:
a) Clause 6 of Article 1 is repealed;
b) The phrase “hồ sơ đề nghị đánh giá định kỳ” (“application for periodic inspection”) in clause 8 and clause 9 of Article 1 is changed to “hồ sơ đánh giá định kỳ” (“dossier on periodic inspection”);
c) The phrase “Sở Y tế” (“provincial Department of Health”) is replaced with the phrase “cơ quan chuyên môn về y tế của tỉnh” (“provincial specialized health authority”).
2. Some Articles of the Circular No. 09/2020/TT-BYT dated June 10, 2020 of the Minister of Health on amendments to some Articles of the Circular No. 03/2018/TT-BYT dated January 22, 2018 of the Minister of Health on Good Distribution Practices for medicinal products and medicinal materials are amended and repealed as follows:
a) Clause 6 and clause 11 of Article 1 are repealed;
b) The phrase “hồ sơ đề nghị đánh giá định kỳ” (“application for periodic inspection”) in clause 7 of Article 1 is changed to “hồ sơ đánh giá định kỳ” (“dossier on periodic inspection”);
c) The phrase “Sở Y tế” (“provincial Department of Health”) is replaced with the phrase “cơ quan chuyên môn về y tế của tỉnh” (“provincial specialized health authority”).
Article 5. Effect
1. This Circular comes into force from July 01, 2025.
2. The regulations stipulating that pharmacy business establishments must fully connect and update data with the pharmacy information system as instructed by the Ministry of Health shall be implemented as of January 01, 2026.
Article 6. Transitional clauses
Any application submitted before the effective date of this Circular shall continue to be processed in compliance with the regulations in force at the time of submission or the regulations of this Circular as of July 01, 2025, whichever is more convenient for the applicant.
Article 7. Responsibility for implementation
1. The Drug Administration of Vietnam shall:
a) Preside over and cooperate with related agencies in organizing the dissemination of this Circular;
b) Act as a conduit and cooperate with related units to provide guidelines on the implementation of this Circular to provincial specialized health authorities, health authorities and pharmacy business establishments within the bounds of its assigned functions and tasks;
c) Inspect the compliance with regulations of this Circular and impose penalties or recommend penalties for violations under its authority.
2. The Traditional Medicine Administration of Vietnam shall:
a) Act as a conduit and cooperate with related units to provide guidelines on the implementation of this Circular to provincial specialized health authorities, health authorities and distributors of traditional medicinal products and herbal materials within the bounds of its assigned functions and tasks;
b) Inspect the compliance with regulations of this Circular and impose penalties or recommend penalties for violations under its authority.
3. Provincial People’s Committees shall direct agencies owned by and affiliated to the provincial People’s Committees to inspect the compliance with good practice principles by pharmacy business establishments within their provinces and direct provincial specialized health authorities to:
a) Cooperate with related agencies in organizing the dissemination of this Circular and provide guidelines on the implementation thereof to units in the localities;
b) Inspect the compliance with regulations of this Circular and impose penalties for violations under their authority.
4. Pharmacy business establishments shall:
a) Organize the study and implementation of this Circular;
b) Comply with good practice principles throughout their operation;
c) Conduct business in medicinal products and medicinal materials within the licensed scope on the basis of compliance with regulations of law.
Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Health (Drug Administration of Vietnam) for consideration and resolution./.
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