Circular No. 02/2018/TT-BYT dated January 22, 2018 of the Ministry of Health on good pharmacy practices

THE MINISTRY OF HEALTH 

Circular No.02/2018/TT-BYT dated January 22, 2018 of the Ministry of Health on good pharmacy practices

Pursuant to the Law on Pharmacy No. 105/2016/QH13 dated April 06, 2016;

Pursuant to the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for implementation of the Law on Pharmacy;

Pursuant to the Government’s Decree No. 75/2017/ND-CP dated June 20, 2017 defining Functions, Tasks, Powers and Organizational Structure of Ministry of Health;

At the request of the Director of the Drug Administration of Vietnam;

Minister of Health promulgates a Circular providing guidelines for Good Pharmacy Practices.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of adjustment

This Circular provides for promulgation and inspection of fulfillment of Good Pharmacy Practice requirements.

Article 2. Interpretation of terms

For the purpose of this Circular, the terms below are construed as follows:

1.“Good Pharmacy Practice"means a set of principles and standards for practice at drug retailers (or pharmacies) with the aims of ensuring and improve the direct supply and retailing of safe and effective drugs to patients.

2.“pharmacist”means a person who takes charge of expertise in pharmacy, works at a pharmacy and has obtained formal qualifications in pharmacy in conformity with the type and scope of operation of that pharmacy.

3."drug retailing”means the professional operation of a pharmacy, including the supply and retailing of drugs directly to patients, accompanied by giving advice and instructions to them on the safe and effective use of medicines.

4.“deficiencies”means deviation from the Good Pharmacy Practice standards or relevant regulations on pharmacy management.

5.“GPP”stands for the phrase “Good Pharmacy Practices”

Chapter II

PROMULGATION AND APPLICATION OF GOOD PHARMACY PRACTICES

Article 3. Good Pharmacy Practice standards

GPP standards are specified in the Appendix I enclosed herewith.

Article 4. Regulated entities of GPP standards

1.Drugstores apply and maintain GPP standards for drugstores specified in the Appendix I – 1a enclosed herewith.

2.Dispensaries apply and maintain GPP standards for dispensaries specified in the Appendix I – 1b enclosed herewith.

3.Drug dispensing counters affiliated to communal medical stations apply and maintain GPP standards for drug dispensing counters specified in the Appendix I – 1c enclosed herewith.

Chapter III

INSPECTION OF FULFILLMENT OF GPP REQUIREMENTS

Article 5. Documents used as basis for inspection of fulfillment of GPP requirements

1.Documents used as the basis for an inspection of fulfillment ofGPP requirements by a pharmacy are those included in its application for Certificate of eligibility for pharmacy business (the pharmacy is not required to submit these documents because they have been submitted when it applies for the Certificate of eligibility for pharmacy business) as prescribed in Article 38 of the Law on Pharmacy and Article 32 of the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for implementation of the Law on Pharmacy (hereinafter referred to as "Decree No. 54/2017/ND-CP”). If a pharmacy trades in controlled drugs, it must have the documents prescribed in Article 38 of the Law on Pharmacy and Article 49 of the Decree No. 54/2017/ND-CP.

Technical documents of a pharmacy include:

a) The organizational chart, list of employees, names, positions and qualifications of employees;

b) The layout plan displaying all areas of a pharmacy;

c) The list of equipment (including information concerning computer system and management software);

d) The list of regulations, dossiers, documentation system and standard operating procedure (SOP);

dd) The complete GPP checklist made according to the form stated in the Appendix II 2a or 2b or 2c enclosed herewith.

2.If a pharmacy applies for both GPP Certificate and Certificate of eligibility for pharmacy business, this content must be clearly specified in its application form for Certificate of eligibility for pharmacy business.

Article 6. Procedures for inspection of fulfillment of GPP requirements

1.Receipt of application:

The pharmacy shall submit an application for inspection, which includes the documents specified in Article 5 herein, accompanied by the application fees as prescribed in the Ministry of Finance’s regulations on fees for processing of applications for certification of pharmacy standards, to the Provincial Department of Health.

2.Procedures for receiving and appraising an application for inspection shall be performed according to:

a) Regulations in Clauses 2, 3, 4, 5 and 6 Article 50 of the Decree No. 54/2017/ND-CP if the applicant is a pharmacy trading in combined drugs that contain narcotic active ingredients, psychotropic active ingredients or precursors; or

b) Regulations in Clauses 2, 3, 4 and 5 Article 51 of the Decree No. 54/2017/ND-CP if the applicant is a pharmacy trading in toxic drugs, toxic medicinal ingredients, drugs and active ingredients on the list of banned substances in certain fields; or

c) Regulations in Clauses 2, 4 and 5 Article 33 of the Decree No. 54/2017/ND-CP if the applicant is a pharmacy other than the ones prescribed in Point a and Point b of this Clause.

3.Within 05 days from the receipt of a valid and satisfactory application, the Provincial Department of Health shall establish an inspection team and inform the applicant of the site inspection conducted at its premises and the expected inspection date. Within 15 days from the date of notification, the inspection team shall conduct a site inspection at the pharmacy premises.

Article 7. Process of inspecting and measuring fulfillment of GPP requirements

1.Inspection process:

a) Step 1. The inspection team will declare the Decision on establishment of inspection team, objectives, contents and plan for the site inspection at the pharmacy premises;

b) Step 2. The applicant shall briefly state contents about its organizational structure, personnel and implementation or application of GPP standards, or specific contents in conformity with the inspected contents;

c) Step 3. The inspection team shall inspect and evaluate the application of GPP standards at the pharmacy premises;

d) Step 4. The inspection team shall have a talk with the applicant about any deficiencies found in the site inspection and the degree of each deficiency; discuss with the applicant in case the applicant does not agree with the inspection team about any deficiency; evaluate and determine the degree of fulfillment of GPP requirements by the applicant;

dd) Step 5. Preparing and certifying inspection report:

The inspection team shall prepare the report on inspection of fulfillment of GPP requirements using the Form No. 02 stated in the Appendix III enclosed herewith. The inspection report must clearly specify the degree of fulfillment of GPP requirements by the pharmacy as prescribed in Clause 2 and Clause 3 of this Article, and deficiencies requiring corrective actions (if any); disagreements between the inspection team and the applicant after careful consideration of the complete checklist pursuant to relevant provisions for such type of pharmacy.

The inspection report must be certified by signatures of the pharmacy manager and the inspection team leader. The inspection report must include contents describing the composition of the inspection team, location, time and extent of inspection, and is prepared in three copies, two of which shall be kept by the Provincial Department of Health and the other is kept by the applicant.

2.Scoring rule:

a) The standard point for each criterion is prescribed in the Checklist stated in the Appendix II 2a, 2b, 2c enclosed herewith according to the step-by-step scoring rule. Each criterion will be given the maximum points; no intermediate points will be given. Plus points will be given if the pharmacy fully complies with GPP requirements. Minus points will be given if the pharmacy partially complies with GPP requirements;

b) An operating pharmacy will be evaluated and scored according to its operations actually carried out;

c) With regard to a newly established pharmacy:

-Criteria applied before its operation will be scored according to actual results;

-Criteria applied after the pharmacy officially starts its operations will be scored by consideration and evaluation of its documents, records, SOP, forms to be used during its operation and evaluation of its personnel (whether they have a thorough understanding of and comply with regulations relating their duties.

Total points used to determine the degree of fulfillment of GPP requirements by a newly established pharmacy shall exclude points of criteria for activities which are not performed by the pharmacy (for example, the pharmacy does not concoct drugs according to prescriptions or the pharmacy does not have a drug storage).

3.Determination of degrees of fulfillment of GPP requirements:

a) The pharmacy is considered to have complied with GPP requirements if it has no criterion given the “non-compliance” points and achieves at least 90% of total points;

b) The pharmacy is required to submit report on corrective actions taken if it has no criterion given the “non-compliance” points and achieves from 80% to under 90% of total points;

c) The pharmacy fails to comply with GPP requirements if it has any criteria given the "non-compliance" points or achieves less than 80% of total points.

Article 8. Dealing with results of inspection of fulfillment of GPP requirements

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 and obtainment of a valid inspection report, the Provincial Department of Health shall issues the Certificate of eligibility for pharmacy business or GPP Certificate to the qualified pharmacy using the Form No. 03 stated in the Appendix III enclosed herewith.

In case a pharmacy trades in controlled drugs, within 20 days from the completion of the site inspection and obtainment of a valid inspection report, the Provincial Department of Health shall issues the Certificate of eligibility for pharmacy business or GPP Certificate to the qualified pharmacy using the Form No. 03 stated in the Appendix III enclosed herewith.

2.If the inspection report indicates that the pharmacy is required to submit report on corrective actions taken as prescribed in Point b Clause 3 Article 7 herein:

a) Within 05 days from the completion of the site inspection at the pharmacy premises and obtainment of a valid inspection report, the Provincial Department of Health shall request the pharmacy in writing to take correction actions against its deficiencies specified in the inspection report.

In case a pharmacy trades in controlled drugs, within 15 days from the completion of the site inspection at the pharmacy premises and obtainment of a valid inspection report, the Provincial Department of Health shall request the pharmacy in writing to take correction actions against its deficiencies specified in the inspection report.

b) Upon completion of corrective actions, the pharmacy must send a written report, accompanied by evidences of its completion of such corrective actions against the deficiencies specified in the inspection report (such as documents, photographs, videos and certifications);

c) Within 20 days from the receipt of the written report on corrective actions taken, the Provincial Department of Health shall evaluate results of correction actions taken by the pharmacy and conclude the degree of fulfillment of GPP requirements by the pharmacy:

-If results of correction actions make the pharmacy meet GPP requirements, the Provincial Department of Health shall issue the Certificate of eligibility for pharmacy business or GPP Certificate to the qualified pharmacy using the Form No. 03 stated in the Appendix III enclosed herewith;

-If results of corrective actions show that the pharmacy still fails to comply with GPP requirements, the Provincial Department of Health shall provide written explanation about its refusal to issue Certificate to the pharmacy.

d) Within 06 months from the receipt of the written request of the Provincial Department of Health for supplementing the application, the pharmacy must supplement and complete the application as requested. Over this time limit, if the pharmacy fails to supplement and complete the application or after 12 months from the date of first submission of application but the pharmacy’s supplemented application is still not satisfactory, the submitted application shall be automatically invalid.

3.If the inspection report indicates that the pharmacy fails to comply with GPP requirements as prescribed in Point c Clause 3 Article 7 herein:Within 05 days from the completion of the site inspection at the pharmacy premises and obtainment of a valid inspection report, the Provincial Department of Health shall inform the pharmacy in writing of its failure to comply with GPP requirements and refusal to issue the Certificate.

4.Within 05 days from the date of issuance of the Certificate of eligibility for pharmacy business or GPP Certificate, the Provincial Department of Health shall publish the following information on its website:

a) Name and address of the pharmacy;

b) Full name of the responsible pharmacist, number of his/her pharmacy practice certificate;

c) Numbers of the Certificate of eligibility for pharmacy business and GPP Certificate (if any);

d) Validity of inspection of fulfillment of GPP requirements;

dd) The scope of operations of the pharmacy.

Chapter IV

INSPECTION OF MAINTENANCE OF FULFILLMENT OF GPP REQUIREMENTS

Article 9. Periodic inspection of maintenance of fulfillment of GPP requirements

1.The maintenance of fulfillment of GPP requirements by a pharmacy must be periodically inspected for every 03 years from the end of the previous inspection (except unexpected inspections or audits by the Ministry of Health or the Provincial Department of Health).

2.Every Provincial Department of Health, in November every year, shall publish the plan for periodic inspection of pharmacies’ maintenance of fulfillment of GPP requirements in the following year on its website.

3.Based on the plan for periodical inspection published by the Provincial Department of Health, the relevant pharmacy, at least 30 days prior to the estimated date of inspection specified in such plan, must submit an application for periodical inspection as prescribed in Clause 7 of this Article to the Provincial Department of Health.

E.g.: If the estimated date of inspection of the pharmacy A is on August 18, 2018, the pharmacy A is required to submit an application for inspection to the Provincial Department of Health by July 18, 2018.

4.If a pharmacy fails to submit the application for periodic inspection within the time limit prescribed in Clause 3 of this Article, it is required to provide a written explanation as requested in writing by the Provincial Department of Health.

5.Within 30 days from the receipt of the Provincial Department of Health’s written request for explanation about its failure to submit the application for periodic inspection, if the pharmacy still fails to submit such application of periodic inspection as prescribed, the Provincial Department of Health shall revoke the Certificate of eligibility for pharmacy business issued to that pharmacy in accordance with regulations in Clause 2 Article 40 of the Law on Pharmacy.

6.The pharmacy is allowed to continue its operations within the scope of operations permitted in the Certificate of eligibility for pharmacy business for the period from the date of submission of application for periodical inspection to the date of receipt of periodic inspection results.

7.The application for periodic inspection of maintenance of fulfillment of GPP requirements includes:

a) The application form for periodic inspection of maintenance of fulfillment of GPP requirements, made according to the Form No. 01 stated in Appendix III enclosed herewith;

b) Technical documents indicating changes in facilities, equipment and personnel of the pharmacy (if any);

c) The brief report on operating results of the pharmacy for the last three years from the date of previous inspection (except unexpected inspections or audits by the Ministry of Health or the Provincial Department of Health) to the date of this periodic inspection.

8.Procedures and process of inspection and determination of degrees of fulfillment of GPP requirements shall follow regulations in Article 6 and Article 7 herein.

Article 10. Dealing with results of periodic inspection of maintenance of fulfillment of GPP requirements

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 obtainment of a valid inspection report, the Provincial Department of Health shall issue the GPP Certificate to the qualified pharmacy using the Form No. 03 stated in the Appendix III enclosed herewith.

2.If the inspection report indicates that the pharmacy is required to submit report on corrective actions taken as prescribed in Point b Clause 3 Article 7 herein:

a) Within 05 days from the completion of the site inspection at the pharmacy premises and obtainment of a valid inspection report, the Provincial Department of Health shall request the pharmacy in writing to take correction actions against its deficiencies and send report thereof to the Provincial Department of Health;

b) Within 45 days from the receipt of the written request from the Provincial Department of Health, the pharmacy must complete corrective actions as requested and send a notification, accompanied by evidences of its completion of such corrective actions against the deficiencies specified in the inspection report (such as documents, photographs, videos and certifications) to the Provincial Department of Health;

c) Within 20 days from the receipt of the written report on corrective actions taken, accompanied by evidences thereof (such as documents, photographs, videos and certifications), the Provincial Department of Health shall evaluate results of correction actions taken by the pharmacy and conclude the degree of fulfillment of GPP requirements by the pharmacy as follows:

-If results of correction actions make the pharmacy meet GPP requirements, the Provincial Department of Health shall issue the GPP Certificate to the pharmacy;

-If results of corrective actions show that the pharmacy still fails to comply with GPP requirements, the Provincial Department of Health shall continue requesting the pharmacy in writing to take more corrective actions and submit additional report. The pharmacy shall have 45 days from the date of receipt of the written request from the Provincial Department of Health to complete corrective actions and send report thereof as requested.

d) Within 90 days from the end of the site inspection, if the pharmacy fails to submit the report on corrective actions taken or fails to fulfill GPP requirements after taking corrective actions as prescribed in Point c of this Clause, the Provincial Department of Health shall inform the pharmacy in writing of its failure to fulfill GPP requirements and impose one or some measures prescribed in Point a, Point b Clause 3 of this Clause depending on the nature and degree of non-fulfillment of GPP requirements of the pharmacy.

3.If the inspection report indicates that the pharmacy fails to comply with GPP requirements as prescribed in Point c Clause 3 Article 7 herein:

Within 05 days from the completion of the site inspection at the pharmacy premises and obtainment of a valid inspection report, based on the evaluation of effects of deficiencies found in the inspection on quality of medicines and safety of patients, the Provincial Department of Health shall inform the pharmacy in writing of its failure to fulfill GPP requirements and impose one or some of the following measures depending on the nature and degree of non-fulfillment of GPP requirements of the pharmacy:

a) Impose administrative penalties according to regulations of the Law on penalties for administrative violations;

b) Revoke the Certificate of eligibility for pharmacy business and GPP Certificate (if any) granted to the pharmacy as prescribed in Article 40 of the Law on Pharmacy.

In case a pharmacy fails to meet requirements for carrying out one or some operations licensed in its Certificate of eligibility for pharmacy business, the Provincial Department of Health shall revoke the Certificate of eligibility for pharmacy business to remove the operations for which the pharmacy is ineligible, revoke the GPP Certificate (if any) as prescribed in Article 40 of the Law on Pharmacy, and issue a new Certificate of eligibility for pharmacy business with respect of operations for which the pharmacy is eligible.

4.Within 05 days from the date of inspection of maintenance of fulfillment of GPP requirements or from the date of issuance of the Decision on revocation of Certificate of eligibility for pharmacy business, the Provincial Department of Health publish the information concerning the fulfillment of GPP requirements by the inspected pharmacy as prescribed in Clause 4 Article 8 herein or information relating the revocation of the Certificate of eligibility for pharmacy business and/or GPP Certificate of the inspected pharmacy on its website.

Article 11. Change management

1.During the interval between periodic inspections, the pharmacy must apply for the Certificate of eligibility for pharmacy business as prescribed in Point b Clause 1 Article 36 of the Law on Pharmacy or submit report on its changes using the Form No. 04 stated in the Appendix III enclosed herewith if:

a) having one of the changes specified in Point b Clause 1 Article 36 of the Law on Pharmacy; or

b) changing the location of its premises at the same business location; or

c) expanding the premises; or

d) repairing or having significant changes in its structure.

2.If having changes as prescribed in Point a Clause 1 of this Article, the pharmacy must apply for the Certificate of eligibility for pharmacy business as prescribed in Clause 2 and Clause 4 Article 38 of the Law on Pharmacy.

Procedures for inspecting and measuring fulfillment of GPP requirements, and dealing with inspection results shall follow regulations in Articles 6, 7 and 8 herein.

3.If having changes as prescribed in Point b Clause 1 of this Article, the pharmacy is required to submit the report on changes, accompanied by relevant technical documents, to the Provincial Department of Health.

a) The Provincial Department of Health shall conduct a site inspection at the pharmacy premises.If the pharmacy complies with GPP requirements,the Provincial Department of Health shall give a written approval for its changes;

b) Procedures for inspecting and measuring fulfillment of GPP requirements by the pharmacy having changes prescribed in Point b Clause 1 of this Article, and dealing with inspection results shall follow regulations in Articles 6, 7 and 10 herein.

4.If having one of the changes prescribed in Point c and Point d Clause 1 of this Article, the pharmacy is required to submit the report on changes, accompanied by relevant technical documents, to the Provincial Department of Health. The Provincial Department of Health shall verify the report on changes submitted by the pharmacy.

a) Within 10 days from the receipt of the report on changes, the Provincial Department of Health shall inform the pharmacy in writing of approval for its changes if they meet requirements;

b) Within 10 days from the receipt of the report on changes, the Provincial Department of Health shall request the pharmacy in writing to take corrective actions if its changes do not comply with requirements;

c) Within 45 days from the receipt of the written request from the Provincial Department of Health, the pharmacy must complete corrective actions as requested and send a notification, accompanied by evidences of its completion of such corrective actions against the deficiencies specified in the written request (such as documents, photographs, videos and certifications) to the Provincial Department of Health;

d) Within 10 days from the receipt of the written report on corrective actions taken, accompanied by evidences thereof (such as documents, photographs, videos and certifications), the Provincial Department of Health shall evaluate results of correction actions taken by the pharmacy and conclude the degree of fulfillment of GPP requirements by the pharmacy as follows:

-If results of corrective actions make the pharmacy meet GPP requirements, the Provincial Department of Health shall give a written approval for its changes;

-If results of corrective actions show that the pharmacy still fails to comply with GPP requirements, the Provincial Department of Health shall conduct an unexpected inspection as prescribed in Article 12 herein.

Article 12. Unexpected inspection, audits of maintenance of fulfillment of GPP requirements

1.The audit of maintenance of fulfillment of GPP requirements by pharmacies shall be carried out in accordance with applicable laws.

2.The Provincial Department of Health shall conduct unexpected inspection of a pharmacy’s maintenance of fulfillment of GPP requirements in the following cases:

a) Results of corrective actions show that the pharmacy still fails to comply with GPP requirements as prescribed in Point d Clause 4 Article 11 herein;

b) There is any denunciation or complaint, or results of audit by a competent authority shows that the pharmacy seriously commits violations against GPP standards.

3.Composition of the inspection team shall be subject to the Director of the Provincial Department of Health s decision according to the extent and purposes of the inspection.

4.Inspection procedures and dealing with results of the site inspection at the pharmacy premises shall follow regulations in Article 7 and Article 10 herein.

Chapter V

INSPECTION TEAMS CONDUCTING INSPECTIONS OF FULFILLMENT OF GPP REQUIREMENTS BY PHARMACIES

Article 13. Composition and standards of members of an inspection team

1.An inspection team shall include:

Team leader, secretary and other members who are representatives of relevant pharmaceutical agencies according to decision of the Director of the Provincial Department of Health. Each inspection team shall include no more than 04 members.

2.A member of the inspection team must satisfy the following requirements:

a) he/she must obtain an undergraduate degree or Bachelor’s degree or intermediate professional education diploma in pharmacy or medicine or higher;

b) he/she has attended training courses in GPP standards and inspection of fulfillment of GPP requirements, and has a thorough grasp of GPP standards;

c) he/she must be honest, objective and strictly comply with inspection rules and law regulations on inspection as well as have no conflict of interest with the inspected pharmacy as prescribed in Clause 3 of this Article;

d) The team leader must hold an undergraduate degree or higher and have at least 02 years of experience in pharmacy management.

3.Principles for assessing conflicts of interest: A member of the inspection team is assessed to have conflicts of interest with the inspected pharmacy if:

a) he/she has worked for the inspected pharmacy in the past five years; or

b) he/she has provided consulting services for the inspected pharmacy in the past five years; or

c) he/she is receiving financial benefits associated with the inspected pharmacy; or

d) his/her spouse, child, parent, sibling or parent-in-law is working at the inspected pharmacy.

Article 14. Rights and responsibilities of an inspection team

1.Responsibilities of the inspection team:

a) Inspect all drug retailing activities on the basis of corresponding GPP standards specified in Article 3 herein and relevant specialized regulations; clearly record inspection contents, deficiencies found and make GPP inspection report;

b) Submit inspection report or written explanation about GPP inspection report in case the pharmacy has any disagreements with the GPP inspection report;

c) Maintain confidentiality of information concerning the inspection and drug retailing activities of the pharmacy, except the case where such information is provided with the consent of the pharmacy or at the request of a competent authority.

2.Rights of the inspection team:

a) Inspect all areas, facilities and equipment of the pharmacy, and have the rights to request for inspection of other areas related to the drug retailing or concoction of the pharmacy;

b) Request the pharmacy to provide documents concerning its business, quality management and drug retailing;

c) Collect documentary evidences (take photocopies of documents, photographs and make videos) of any deficiencies found during the inspection;

d) Take samples of medicines to test their quality as regulated by law.

dd) Make inspection report and request the pharmacy to suspend its operation if the inspection team detects any violations which may cause adverse effects on quality of one or some medicine products; request the competent official to make official decision on handling of violations.

Chapter VI

IMPLEMENTATION ORGANIZATION

Article 15. Effect

1.This Circular takes effect on March 08, 2018.

2.The Circular No. 46/2011/TT-BYT dated December 21, 2011 by Minister of Health on promulgation of Good Pharmacy Practices shall be null and void as from the effective date of this Circular.

Article 16. Transitional provisions

1.Pharmacies holding an unexpired Certificate of eligibility for pharmacy business or a GPP Certificate which has been granted before the date of entry into force of this Circular may continue their drug retailing activities until the end of validity specified in such Certificates.

When the Certificate of eligibility for pharmacy business is unexpired, the pharmacy must apply for a new Certificate of eligibility for pharmacy business according to regulations in Chapter III herein.

If the GPP Certificate is unexpired before the Certificate of eligibility for pharmacy business, the pharmacy must apply for inspection of maintenance of fulfillment of GPP requirements as prescribed in Chapter IV herein so as to continue its drug retailing until the end of validity of the Certificate of eligibility for pharmacy business.

2.If a pharmacy has a Certificate of eligibility for pharmacy business with indefinite term, when ending the validity of its GPP Certificate, it is required to apply for inspection of maintenance of fulfillment of GPP requirements according to regulations in Chapter IV herein.

3.With regard to applications for Certificate of eligibility for pharmacy business or applications for periodic inspection of maintenance of fulfillment of GPP requirements submitted to Provincial Departments of Health before the date of entry into force of this Circular, Provincial Departments of Health shall conduct site inspection of pharmacies in accordance with regulations of the Circular No. 46/2011/TT-BYT dated December 21, 2011 by Minister of Health on promulgation of Good Pharmacy Practices or regulations herein if they deem conformable with the reality of the inspected pharmacy.

Article 17. Implementation responsibilities

1.Drug Administration of Vietnam shall:

a) Take charge and cooperate with relevant agencies to disseminate this Circular;

b) Consolidate and publish the list of pharmacies nationwide which have been granted Certificates of eligibility for pharmacy business, information about status of Certificates of eligibility for pharmacy business and GPP Certificates, and other information as prescribed in Clause 4 Article 8 herein on its website within the ambit of assigned functions and duties;

c) Take charge or cooperate with the Inspectorate of the Ministry of Health to conduct inspection of compliance with regulations herein and take actions against violations intra vires;

d) Cooperate with relevant agencies to develop and provide pharmacy software.

2.Every Provincial Department of Health shall:

a) Cooperate with relevant agencies to disseminate this Circular and instruct the application of this Circular to pharmacies in the province;

b) Receive applications for Certificate of eligibility for pharmacy business or applications for inspection of maintenance of fulfillment of GPP requirements; conduct inspection of fulfillment of GPP requirements; issue Certificates of eligibility for pharmacy business and GPP Certificates to qualified pharmacies in the province;

c) Publish the list of pharmacies nationwide which have been granted Certificates of eligibility for pharmacy business, information about status of Certificates of eligibility for pharmacy business and GPP Certificates, and other information as prescribed in Clause 4 Article 8 herein on its website within the ambit of assigned functions and duties;

d) Inspect the compliance with law by pharmacies in the province; take actions against any violations intra vires;

dd) Send quarterly report on the list of pharmacies in the province which have been granted Certificates of eligibility for pharmacy business, and their degrees of fulfillment of GPP requirements as prescribed in Clause 4 Article 8 herein to the Drug Administration of Vietnam.

3.Every pharmacy shall:

a) Organize the implementation of applicable regulations on pharmacy and GPP standards promulgated under this Circular;

b) Maintain its fulfillment of GPP requirements during its drug retailing;

c) Carry out drug retailing activities within the scope of business and in compliance with law regulations.

Any difficulties arising in the course of this Circular should be promptly reported to the Ministry of Health for consideration./.

For the Minister

The Deputy Minister

Truong Quoc Cuong

 * All Appendices are not translated herein.