Circular No. 02/2018/TT-BYT on Good Practices for Retail Pharmaceutical Outlets

CIRCULAR

Regulations on Good Pharmacy Practices for Retail Drug Outlets

Pursuant to Law No. 105/2016/QH13 dated April 6, 2016 on pharmaceuticals;

Pursuant to Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government detailing certain provisions and implementing mechanisms of the Pharmaceutical Law;

Decree No. 75/2017/NĐ-CP dated 20 the 6 Article 2. The receipt, handling of reflections and petitions from individuals and organizations concerning administrative regulations shall be carried out in accordance with Decree No. 20/2008/NĐ-CP dated February 14, 2008 of the Government on the receipt, handling of reflections and petitions from individuals and organizations concerning administrative regulations (amended and supplemented by Decree No. 48/2013/NĐ-CP dated May 14, 2013 on amending and supplementing certain articles of decrees related to administrative procedure control and Decree No. 92/2017/NĐ-CP dated August 7, 2017 on amending and supplementing certain articles of decrees related to administrative procedure control).7 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Drug Administration Department,

Article 1. Amending and supplementing some articles of Circular No. 21/2023/TT-BTTTT dated December 31, 2023 of the Ministry of Information and Communications on functions and technical features of the Administrative Procedure Handling Information System at the ministerial and provincial levels (hereinafter referred to as Circular No. 21/2023/TT-BTTTT) as follows: The Ministry of Health issues this Circular regulating Good Pharmacy Practices for Retail Drug Outlets. 

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates the issuance and evaluation of compliance with Good Pharmacy Practices for Retail Drug Outlets.

Article 2. Interpretation of Terms

In this Circular, the following terms are understood as follows:

1. Good Pharmacy Practices for Retail Drug Outlets are a set of principles and standards in the practice at retail drug outlets aimed at ensuring the supply and direct sale of drugs to end-users and encouraging safe and effective drug use for users.

2. Retail drug seller is the person responsible for professional matters related to pharmaceuticals and staff working at retail drug outlets who have appropriate qualifications and training in pharmaceuticals suitable for the type and scope of operations of the outlet.

3. Retailing of drugs is the professional activity of retail drug outlets including the provision and direct sale of drugs to end-users along with counseling and guidance on safe and effective drug use for users.

4. Deviation is deviation from the principles and standards of Good Pharmacy Practices for Retail Drug Outlets or other legal regulations on pharmaceutical management.

5. GPP is the abbreviation in English for "Good Pharmacy Practices," which translates to Vietnamese as "Good Pharmacy Practices for Retail Drug Outlets."

Chapter II

ISSUANCE AND APPLICATIONGOOD PHARMACY PRACTICES FOR RETAIL DRUG OUTLETS

Article 3. Principles and Standards of Good Pharmacy Practices for Retail Drug Outlets

Issuing principles and standards of GPP as specified in Appendix I attached to this Circular.

Article 4. Subjects to Apply Principles and Standards of Good Pharmacy Practices for Retail Drug Outlets

1. Pharmacies shall implement and meet the GPP standards for pharmacies as defined in Appendix I - 1a attached to this Circular.

2. Medicine counters shall implement and meet the GPP standards for medicine counters as defined in Appendix I - 1b attached to this Circular.

3. Village health station medicine cabinets shall implement and meet the GPP standards for medicine cabinets as defined in Appendix I - 1c attached to this Circular.

Chapter III

EVALUATION OF COMPLIANCEGOOD PHARMACY PRACTICES FOR RETAIL DRUG OUTLETS

Article 5. Documents as Basis for Evaluating Compliance with Good Pharmacy Practices for Retail Drug Outlets

1. The documents serving as basis for evaluating compliance with GPP for retail drug outlets are the application documents for the Certificate of Eligibility for Pharmaceutical Business Operations (which must be submitted when applying for the Certificate of Eligibility for Pharmaceutical Business Operations, retail drug outlets do not need to submit additional documents), implemented according to Article 38 of the Pharmaceutical Law and Article 32 of Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government detailing certain provisions and implementing mechanisms of the Pharmaceutical Law (hereinafter referred to as Decree No. 54/2017/NĐ-CP). In cases where retail drug outlets engage in the business of special control drugs, they must comply with the provisions of Article 38 of the Pharmaceutical Law and Article 49 of Decree No. 54/2017/NĐ-CP.

Technical documents about retail drug outlets include:

a) Staff organization chart, list of staff, names, positions, and professional qualifications;

b) Layout plan of areas within the retail drug outlet;

c) List of equipment (including information on computer systems and networked management software);

d) List of regulations, documents, standard operating procedures;

đ) Self-inspection report on Good Pharmacy Practices for Retail Drug Outlets according to the inspection checklist specified in Appendix II 2a, 2b, or 2c attached to this Circular for corresponding retail drug outlets applying for the Certificate of Eligibility for Pharmaceutical Business Operations.

2. In cases where retail drug outlets apply for both the GPP Certificate and the Certificate of Eligibility for Pharmaceutical Business Operations, the retail drug outlets must clearly state this in the Application Form for the Certificate of Eligibility for Pharmaceutical Business Operations.

1. Receiving documents:

The retail pharmacy shall submit one set of documents as prescribed in Article 5 of this Circular along with the fee for assessment as stipulated by the Ministry of Finance regarding the assessment fee for retail drug conditions and standards to the Department of Health of the province or centrally governed city (hereinafter referred to as the Department of Health).

2. The procedure for receiving and reviewing the documents is carried out in accordance with the provisions of:

a) Clauses 2, 3, 4, 5, and 6 of Article 50 of Decree No. 54/2017/ND-CP for pharmacies that sell combined drugs containing addictive substances, combined drugs containing psychotropic substances, and combined drugs containing precursors.

b) Clauses 2, 3, 4, and 5 of Article 51 of Decree No. 54/2017/ND-CP for retail pharmacies selling toxic drugs, raw materials for making drugs; drugs, pharmaceutical substances listed in the list of prohibited substances in certain sectors.

c) Clauses 2, 4, and 5 of Article 33 of Decree No. 54/2017/ND-CP for pharmaceutical businesses not falling under the cases specified in points a and b of this Clause.

3. Within five days from the date of receiving valid documents, the Department of Health shall establish an Evaluation Team, notify the retail pharmacy about the Evaluation Team and the anticipated time for on-site evaluation. Within fifteen days from the date of the notification, the Evaluation Team shall conduct the actual on-site evaluation at the retail pharmacy.

Article 7. Process of evaluating compliance and classifying compliance with Good Pharmacy Practice (GPP)

1. Evaluation Process:

a) Step 1. The Evaluation Team announces the Decision to establish the Evaluation Team, the purpose, content, and planned schedule for the evaluation at the retail pharmacy.

b) Step 2. The retail pharmacy presents a summary of its organizational structure, personnel, and implementation of GPP or specific content according to the evaluation period.

c) Step 3. The Evaluation Team conducts an on-site evaluation of the implementation of GPP at the retail pharmacy according to specific contents.

d) Step 4. The Evaluation Team meets with the retail pharmacy to inform them of any issues discovered during the evaluation (if any); assess the severity of each issue; discuss with the retail pharmacy if there is disagreement between the Evaluation Team's assessment and the retail pharmacy's view on each issue; classify the level of compliance with GPP of the retail pharmacy.

e) Step 5. Draft and sign the minutes:

The Evaluation Team is responsible for drafting the GPP Evaluation Minutes according to Model No. 02 attached as Appendix III to this Circular; the minutes must classify the level of compliance with GPP of the retail pharmacy as prescribed in Clause 2 and Clause 3 of this Article and list and analyze the issues that the retail pharmacy needs to address (if any); compare the provisions with the corresponding checklist scores based on the type of retail pharmacy, the agreed and disagreed contents between the Evaluation Team and the retail pharmacy.

The GPP Evaluation Minutes shall be signed and confirmed by the Leader of the retail pharmacy and the Head of the Evaluation Team. The minutes must reflect the members of the Evaluation Team, the location, scope of the evaluation, and be made in three copies: one copy retained by the retail pharmacy, two copies retained by the Department of Health.

2. Scoring Principles:

a) The standard score for each criterion is defined in the Checklist at Appendix II 2a, 2b, 2c of this Circular according to the principle of step-by-step scoring. The score for each criterion must be the maximum score, no intermediate scores are given. Additional points are applied if the retail pharmacy performs above the minimum requirement. Deductions are made if the retail pharmacy implements the criteria but still has many issues.

b) For operating retail pharmacies, the evaluation and scoring are based on the actual operations at the retail pharmacy.

c) For newly established retail pharmacies that have not yet commenced operations:

- Criteria implemented before operations: scored based on the actual implementation results;

- Criteria implemented after the retail pharmacy commences operations: scored based on the operational procedures, standard operating procedures, forms for implementing activities, and the evaluation of retail pharmacy staff on their understanding and correct application of relevant regulations according to job descriptions.

The total score for classifying compliance of the retail pharmacy does not include criteria for non-operating pharmacies (pharmacies that do not prepare medications according to prescriptions, pharmacies without storage facilities).

3. Classification of Compliance with GPP:

a) Retail pharmacy compliant with GPP: The retail pharmacy does not commit any unacceptable errors and achieves 90% or more of the total score.

b) Retail pharmacy required to report corrective actions: The retail pharmacy does not commit any unacceptable errors and achieves between 80% and less than 90% of the total score.

c) Non-compliant retail pharmacy: The retail pharmacy commits one or more unacceptable errors or achieves less than 80% of the total score.

Article 8. Handling the Results of Good Pharmacy Practice (GPP) Compliance Assessment for Retail Drug Outlets

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

Within ten days from the date of completion of the on-site assessment at the retail drug outlet and signing of the assessment report, the Department of Health shall issue a Certificate of Eligibility for Pharmaceutical Business Operations or a GPP Compliance Certificate according to Model No. 03 specified in Appendix III attached to this Circular.

In cases where the retail drug outlet engages in the sale of specially controlled drugs, within twenty days from the date of completion of the on-site assessment at the outlet and signing of the assessment report, the Department of Health shall issue a Certificate of Eligibility for Pharmaceutical Business Operations or a GPP Compliance Certificate according to Model No. 03 specified in Appendix III attached to this Circular.

2. In cases where the GPP assessment report concludes that the retail drug outlet must submit a corrective action report as stipulated in Point b, Clause 3, Article 7 of this Circular:

a) Within five days from the date of completion of the on-site assessment at the outlet and signing of the assessment report, the Department of Health shall send a written notice requesting the retail drug outlet to rectify and address deficiencies recorded in the assessment report.

In cases where the retail drug outlet engages in the sale of specially controlled drugs, within fifteen days from the date of completion of the on-site assessment at the outlet and signing of the assessment report, the Department of Health shall send a written notice requesting the retail drug outlet to rectify and address deficiencies recorded in the assessment report.

b) After completing the rectification and correction, the retail drug outlet must submit a written notification accompanied by evidence (documentation files, images, videos, certificates) proving the completion of the rectification and correction of deficiencies recorded in the assessment report;

c) Within twenty days from the date of receipt of the report on rectification, the Department of Health shall evaluate the results of rectification by the retail pharmacy and conclude on the status of compliance with GPP of the retail pharmacy:

- If the rectification measures taken by the retail drug outlet meet the requirements, the Department of Health shall issue a Certificate of Eligibility for Pharmaceutical Business Operations or a GPP Compliance Certificate according to Model No. 03 specified in Appendix III attached to this Circular;

- If the rectification measures taken by the retail drug outlet do not meet the requirements, the Department of Health shall issue a written response explaining the reasons for non-issuance.

d) Within six months from the date the Department of Health issues a request for modification and supplementation, the retail drug outlet must submit a modified and supplemented application as required. After this period, if the retail drug outlet does not modify and supplement or if the supplementary application submitted twelve months after the initial application does not meet the requirements, the previously submitted application will lose its validity.

3. In cases where the GPP assessment report concludes that the retail drug outlet does not comply with GPP as stipulated in Point c, Clause 3, Article 7 of this Circular: Within five days from the date of completion of the on-site assessment at the retail drug outlet and signing of the assessment report, the Department of Health shall issue a written notice to the retail drug outlet regarding non-compliance with GPP and non-issuance of a certificate.

4. Within five days from the date of issuance of the Certificate of Eligibility for Pharmaceutical Business Operations or the GPP Compliance Certificate, the Department of Health shall publish the following information on the Department's electronic information website:

a) Name and address of the retail drug outlet;

b) Name of the person responsible for pharmaceutical expertise and their Pharmaceutical Practitioner License number;

c) Number of the Certificate of Eligibility for Pharmaceutical Business Operations and the GPP Compliance Certificate (if applicable);

d) Expiry date of the GPP compliance inspection;

đ) Scope of operation of the retail drug outlet.

Chapter IV

ASSESSMENT OF THE MAINTENANCE OF COMPLIANCEGOOD PHARMACY PRACTICES FOR RETAIL DRUG OUTLETS

Article 9. Periodic Assessment of Compliance with Good Pharmacy Practice (GPP)

1. The periodic assessment period for compliance with GPP at retail pharmacies is three years, starting from the day following the end of the previous assessment (excluding any unscheduled assessments, inspections, or checks conducted by the Ministry of Health or the Department of Health).

Example: If the planned assessment date at Retail Pharmacy A is August 18, 2018, then Retail Pharmacy A must submit the application for periodic assessment to the Department of Health by July 18, 2018.

5. Within thirty days from the date the Department of Health issues a document requesting the retail pharmacy to report and explain the reasons for not submitting the application for periodic assessment, if the retail pharmacy still fails to submit the application for periodic assessment as required, the Department of Health will revoke the Certificate of Eligibility for Pharmaceutical Business Operations of the retail pharmacy according to Clause 2 of Article 40 of the Drug Law.

b) Updated technical documentation regarding the physical facilities, equipment, and personnel of the retail pharmacy (if there have been changes);

c) A summary report on the operations of the retail pharmacy over the last three years, calculated from the date of the last assessment (excluding any unscheduled assessments, inspections, or checks conducted by the Ministry of Health or the Department of Health) up to the date of the periodic assessment.

8. The procedures for assessment, the assessment process, and classification of compliance with GPP shall be carried out in accordance with the provisions of Articles 6 and 7 of this Circular.

Article 10. Handling Results of Periodic Assessment of Compliance with Good Pharmacy Practice (GPP)

Within ten days from the date of completing the actual assessment at the retail pharmacy and signing the assessment record, the Department of Health shall issue the Certificate of Compliance with GPP according to Form No. 03 stipulated in Appendix III attached to this Circular.

2. In cases where the GPP assessment report concludes that the retail drug outlet must submit a corrective action report as stipulated in Point b, Clause 3, Article 7 of this Circular:

a) Within five days from the date of completing the actual assessment at the retail pharmacy and signing the assessment record, the Department of Health shall issue a document requesting the retail pharmacy to take corrective actions and submit a report on these actions to the Department of Health;

b) Within forty-five days from the date the Department of Health issues the request, the retail pharmacy must complete the corrective actions and submit a report on these actions along with supporting evidence (documents, images, videos, certificates) proving that the corrective actions have been completed;

- If the corrective actions taken by the retail pharmacy meet the requirements: The Department of Health shall issue the Certificate of Compliance with GPP;

- If the corrective actions taken by the retail pharmacy do not meet the requirements: The Department of Health shall issue a document requesting further corrective actions and submit a supplementary report. The extended period for continuing corrective actions and reporting is forty-five days from the date of issuing the request.

d) Within ninety days from the date of completing the actual assessment, if the retail pharmacy does not submit a report on corrective actions or if the results of the corrective actions still do not meet the requirements after the measures stipulated in Point c of Clause 3 of this Article, the Department of Health shall issue a notice of non-compliance with GPP and, depending on the nature and degree of non-compliance with GPP, implement one or more measures as provided for in Point a, b of Clause 3 of this Article.

3. In cases where the GPP assessment record concludes that the retail pharmacy does not comply with GPP as stipulated in Point c of Clause 3 of Article 7 of this Circular:

Within five days from the date of completing the assessment at the retail pharmacy and signing the assessment record, based on the evaluation of the risks associated with the quality of drugs and the safety of users, the Department of Health shall issue a notice of non-compliance with GPP and, depending on the nature and degree of non-compliance with GPP, implement one or more of the following measures:

a) Administrative penalties according to laws on administrative violations.

b) Revoke the Certificate of Eligibility for Pharmaceutical Business Operations and the Certificate of Compliance with GPP (if issued) according to Article 40 of the Drug Law.

In cases where the retail pharmacy does not comply with one or several business scopes specified in the Certificate of Eligibility for Pharmaceutical Business Operations, the Department of Health shall revoke the Certificate of Eligibility for Pharmaceutical Business Operations to remove the non-compliant business scopes and revoke the Certificate of Compliance with GPP (if issued) according to Article 40 of the Drug Law, and issue a new Certificate of Eligibility for Pharmaceutical Business Operations consistent with the business scopes that the retail pharmacy complies with.

4. Within five days from the date when the retail pharmacy is assessed to maintain compliance with GPP or from the date of issuance of the decision to revoke the Business Registration Certificate for pharmaceuticals issued due to the retail pharmacy's failure to maintain compliance with GPP, the Department of Health shall update the status of GPP compliance on the Department of Health’s Electronic Information Website in accordance with the content prescribed in Clause 4, Article 8 of this Circular for cases where the retail pharmacy complies with GPP or information about the revocation of the Business Registration Certificate for pharmaceuticals, the GPP Certificate (if applicable).

Article 11. Change Control

1. During the period between periodic assessment cycles, the retail pharmacy must submit an application for issuance of the Business Registration Certificate for pharmaceuticals in accordance with Point b, Clause 1, Article 36 of the Medicine Law or submit a change report in Form No. 04 prescribed in Appendix III attached to this Circular if it falls under any of the following circumstances:

a) There is one of the changes prescribed in Point b, Clause 1, Article 36 of the Medicine Law;

b) Change in the location of the retail pharmacy at the same business site;

c) Expansion of the retail pharmacy;

d) Repair, major structural changes to the retail pharmacy.

2. In the case where the retail pharmacy has a change as prescribed in Point a, Clause 1 of this Article, the retail pharmacy must submit an application for issuance of the Business Registration Certificate for pharmaceuticals in accordance with Clause 2 and Clause 4, Article 38 of the Medicine Law.

The procedures for assessing compliance with GPP, classifying results, and handling assessment results shall be carried out in accordance with the provisions of Articles 6, 7, and 8 of this Circular.

3. In the case where the retail pharmacy has a change as prescribed in Point b, Clause 1 of this Article, the retail pharmacy must submit a change report along with corresponding technical documentation to the Department of Health.

a) The Department of Health conducts an on-site assessment at the retail pharmacy. If the retail pharmacy meets the requirements, the Department of Health issues a document agreeing with the change made by the retail pharmacy;

b) The procedures for assessing, classifying results, and handling assessment results for the retail pharmacy that has a change as prescribed in Point b, Clause 1 of this Article shall be carried out in accordance with the provisions of Articles 6, 7, and 10 of this Circular.

4. In the case where the retail pharmacy has a change as prescribed in Points c and d, Clause 1 of this Article, the retail pharmacy must submit a change report along with corresponding technical documentation to the Department of Health. The Department of Health shall assess the change report submitted by the retail pharmacy.

a) Within ten days from the date of receipt of the notification document, the Department of Health shall issue a notification document agreeing with the content of the change if the change meets the requirements;

b) Within ten days from the date of receipt of the notification document, the Department of Health shall issue a notification document specifying the contents that need to be rectified and corrected if the requirements are not met;

c) Within forty-five days from the date the Department of Health issues the notification document, the retail pharmacy must complete the rectification and correction and submit a notification document accompanied by evidence (documentation files, images, videos, certificates) proving the completion of the rectification and correction mentioned in the notification document;

d) Within ten days from the date of receipt of the rectification report accompanied by evidence (documentation files, images, videos, certificates) proving the rectification, the Department of Health shall evaluate the rectification result of the retail pharmacy and conclude on the status of GPP compliance of the retail pharmacy:

- In the case where the rectification meets the requirements: The Department of Health shall issue a notification document agreeing with the content of the change;

- In the case where the rectification does not meet the requirements: The Department of Health shall conduct an urgent assessment and handle the assessment results in accordance with the provisions of Article 12 of this Circular.

Article 12. Sudden assessment, inspection, and supervision of the maintenance of Good Pharmacy Practice (GPP) at retail drug outlets

1. The work of inspecting and supervising the maintenance of GPP at retail drug outlets shall be carried out in accordance with the provisions of the law.

2. The Department of Health shall conduct sudden assessments of the maintenance of GPP at retail drug outlets in any of the following cases:

a) The retail drug outlet has not yet met the requirements for rectification as stipulated in Point d Clause 4 Article 11 of this Circular;

b) There is information reflecting, suggesting, or the results of inspections and supervision by competent authorities concluding that there are serious violations of the principles and standards of GPP.

3. The composition of the Assessment Team shall be decided by the Director of the Department of Health according to the scope and purpose of the assessment.

4. The procedures for conducting the assessment and handling the results of the assessment at retail drug outlets shall be implemented in accordance with the provisions of Article 7 and Article 10 of this Circular.

Chapter V

ASSESSMENT TEAMGOOD PHARMACY PRACTICES FOR RETAIL DRUG OUTLETS

Article 13. Composition and Standards for Members of the Evaluation Team

1. The composition of the Evaluation Team includes:

The Head, Secretary, and members representing relevant units involved in pharmaceutical management shall be decided by the Director of the Department of Health. The number of members of the Assessment Team shall not exceed four people.

2. Staff participating in the Evaluation Team must meet the following standards:

a) Having a bachelor's degree or higher in pharmacy or medicine;

b) Having been trained and instructed on GPP, inspection, and assessment of GPP, and mastering the principles and standards of GPP;

c) Being honest, objective, and strictly adhering to regulations and laws during the assessment process without having conflicts of interest with the assessed retail drug outlet as stipulated in Clause 3 of this Article;

d) The Head of the Assessment Team must have a bachelor's degree in pharmacy or higher and at least two years of experience in pharmaceutical management.

3. Conflict of Interest Assessment Principle: An Assessment Team member shall be considered to have a conflict of interest with the assessed retail drug outlet if they fall under any of the following circumstances:

a) Having worked for the assessed retail drug outlet within the last five years;

b) Having participated in advisory activities for the assessed retail drug outlet within the last five years;

c) Currently having financial interests with the assessed retail drug outlet;

d) Having a spouse, child, parent, sibling, father or mother of the spouse, or father or mother of the husband working for the assessed retail drug outlet.

Article 14. Responsibilities and Authorities of the Evaluation Team

1. Responsibilities of the Inspection Team:

a) Conduct a comprehensive evaluation of all retail drug selling activities in accordance with the corresponding GPP principles and standards set forth in Article 3 of this Circular and current specialized regulations related thereto; record specific contents of the assessment, issues identified, and prepare a GPP assessment report;

b) Report the assessment results or provide explanations regarding the GPP assessment report when the retail drug outlet disagrees with the contents of the GPP assessment report;

c) Maintain confidentiality of all information related to the assessment period and all information related to the retail drug selling activities of the retail drug outlet, except where the retail drug outlet consents or upon request by authorized state agencies for inspection, supervision, or investigation purposes;

2. Authorities of the Inspection Team:

a) Inspect all areas and equipment of the retail drug outlet and have the authority to request inspections of other areas related to retail drug selling and compounding activities of the retail drug outlet;

b) Request the provision of documents and materials related to business operations, quality management, and retail drug selling activities of the retail drug outlet;

c) Collect evidence through documentation (photocopies of documents, photographs, videos) to prove issues identified during the assessment;

d) Take samples of drugs for quality testing in accordance with the law;

đ) Prepare a report and require the retail drug outlet to temporarily suspend its retail drug selling activities if the Assessment Team identifies serious violations affecting the quality of one or more drug products during the assessment; report to the authorized person to issue a formal decision on handling.

Chapter VI

IMPLEMENTING PROVISIONS

1. This Circular takes effect from March 8, 2018.

2. Circular No. 46/2011/TT-BYT dated December 21, 2011, issued by the Minister of Health on the principles of Good Pharmacy Practice (GPP) for pharmacies, shall cease to be effective from the date this Circular takes effect.

1. For retail drug outlets that have been granted a Certificate of Eligibility for Pharmaceutical Business Operations or a GPP Certificate with remaining validity before the date this Circular takes effect, the outlet may continue to sell drugs until the expiration date stated on the certificate.

In case the Certificate of Eligibility for Pharmaceutical Business Operations expires, the retail drug outlet must proceed with the application for a new Certificate of Eligibility for Pharmaceutical Business Operations in accordance with Chapter III of this Circular.

In case the GPP Certificate expires earlier, the retail drug outlet must proceed with the application for an assessment of the maintenance of GPP in accordance with Chapter IV of this Circular to continue operations until the expiration date stated on the Certificate of Eligibility for Pharmaceutical Business Operations.

2. For retail drug outlets that have been granted an unlimited-term Certificate of Eligibility for Pharmaceutical Business Operations, when the GPP Certificate expires, the retail drug outlet must proceed with the application for an assessment of the maintenance of GPP in accordance with Chapter IV of this Circular.

3. For applications for a Certificate of Eligibility for Pharmaceutical Business Operations or periodic GPP compliance assessment applications submitted to the Department of Health before the date this Circular takes effect, the Department of Health shall assess the retail drug outlet in accordance with Circular No. 46/2011/TT-BYT dated December 21, 2011, issued by the Minister of Health on the principles of Good Pharmacy Practice (GPP) for pharmacies or this Circular, whichever is appropriate given the actual conditions of the retail drug outlet.

Article 17. 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) Compile and publish on the website of the Drug Administration the list of retail drug outlets nationwide that have been granted Certificates of Eligibility for Pharmaceutical Business Operations, update the status of Certificates of Eligibility for Pharmaceutical Business Operations, GPP compliance status, and other information as stipulated in Clause 4 Article 8 of this Circular, within the scope of their assigned functions and responsibilities;

c) Serve as the lead or coordinate with the Ministry of Health Inspectorate to implement inspections and supervision of compliance with the provisions of this Circular and handle violations within their authority;

d) Coordinate with relevant units to implement the development and provision of software programs for managing drugs at retail drug outlets.

2. The Department of Health shall be responsible for:

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

b) Carry out the acceptance of applications for the issuance of Certificates of Eligibility for Drug Business or evaluations to maintain compliance with Good Pharmacy Practice (GPP); conduct GPP assessments; issue Certificates of Eligibility for Drug Business and GPP Certificates for retail drug outlets within the jurisdiction.

d) Inspect and audit the compliance of retail drug outlets within the jurisdiction; handle violations within the authority granted.

đ) Report periodically every quarter the updated list of retail drug outlets within the jurisdiction that have been issued Certificates of Eligibility for Drug Business, the status of compliance with GPP of retail drug outlets according to the content prescribed in Clause 4, Article 8 of this Circular to the Drug Administration of Vietnam.

3. Retail drug outlets shall be responsible for:

a) Organizing the implementation of current regulations on pharmaceuticals and standards promulgated in this Circular.

b) Ensuring continuous compliance with GPP standards throughout the operation of the retail drug outlet.

During implementation, if there are difficulties or obstacles, please report them to the Ministry of Health for consideration and resolution./.