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MINISTRY OF HEALTH SOCIALIST REPUBLIC OF VIETNAM
------- Independence – Freedom – Happiness
---------------
No.: 02/2018/TT-BYT Hanoi, January 22, 2018
CIRCULAR
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
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”, which means “Thực hành tốt cơ sở bán lẻ thuốc”
in Vietnamese.
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 of GPP 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;
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