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MINISTRY OF
HEALTH
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SOCIALIST
REPUBLIC OF VIET NAM
Independence-Freedom-Happiness
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No.:
12/2020/TT-BYT
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Hanoi, June 22,
2020
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CIRCULAR
AMENDING
CIRCULAR NO. 02/2018/TT-BYT DATED JANUARY 22, 2018 OF MINISTER OF HEALTH ON GOOD
PHARMACY PRACTICE
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.
155/2018/ND-CP dated November 12, 2018 providing amendments to some articles
related to business conditions under state management of the Ministry of
Health;
Pursuant to the Government’s Decree No.
75/2017/ND-CP dated June 20, 2017 defining functions, tasks, powers and
organizational structure of the Ministry of Health;
At the request of the Director of the Drug
Administration of Vietnam affiliated to the Ministry of Health;
The Minister of Health promulgates a Circular
providing amendments to the Circular No. 02/2018/TT-BYT dated January 22, 2018
of the Minister of Health on good pharmacy practice.
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1. The first paragraph of Clause 1 Article 5 is
amended as follows:
“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
the pharmacy 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”). A pharmacy that sells controlled drugs shall comply with the
provisions in Article 38 of the Law on pharmacy, Article 49 of Decree No.
54/2017/ND-CP and Clause 31 Article 5 of the Government’s Decree No.
155/2018/ND-CP dated November 12, 2018 providing amendments to some articles
related to business conditions under state management of the Ministry of Health
(hereinafter referred to as "Decree No. 155/2018/ND-CP”).
2. Clause 2 Article 6 is amended as follows:
“2. Procedures for receipt and appraisal of
an application shall be carried out in accordance with Clause 2 and Clause 5
Article 33 and Article 49 of Decree No. 54/2017/ND-CP and Clause 12 Article 5
of Decree No. 155/2018/ND-CP.”
3. Point dd Clause 1 of Article 7 is amended as
follows:
“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 in 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, deficiencies requiring corrective actions (if any),
and disagreements between the inspection team and the pharmacy after the
complete checklist has been carefully considered according 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 02
copies of which 01 copy shall be kept by the pharmacy and the other is kept by
the provincial Department of Health”.
4. Clause 1 Article 8 is amended as follows:
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Within 10 days from the completion of the site
inspection and obtainment of a valid inspection report, the Provincial
Department of Health shall issue Certificate of eligibility for pharmacy
business or GPP Certificate to the qualified pharmacy according to the Form No.
03 in Appendix III enclosed herewith”.
5. Point a and Point c Clause 2 Article 8 are
amended as follows:
“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 corrective actions against its deficiencies specified in the
inspection report;
c) Within 20 days from the receipt of the written
report on corrective actions, the Provincial Department of Health shall
evaluate results of corrective actions taken by the pharmacy and conclude the
degree of fulfillment of GPP requirements by the pharmacy:
- If the pharmacy has fulfilled the GPP
requirements, the Provincial Department of Health shall issue the Certificate
of eligibility for pharmacy business and/or GPP Certificate according to Form
No. 03 in Appendix III enclosed herewith;
- If the pharmacy still fails to fulfill the GPP
requirements, the Provincial Department of Health shall provide the written
explanation about its refusal to issue Certificate to the pharmacy.”
6. Clause 4 Article 9 is amended as follows:
“4. If a pharmacy fails to submit the application
for periodic inspection within the time limit prescribed in Clause 3 of this
Article, within 15 days from the deadline for submission of the application for
periodic inspection, the Provincial Department of Health shall request the
pharmacy in writing to submit the application for periodic inspection.”
7. Clause 5 Article 9 is amended as follows:
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8. Clause 7a is added to Article 9 as follows:
“7a. The pharmacy shall submit 01 set of application
for periodic inspection of maintenance of fulfillment of the GPP requirements
and inspection 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.”
9. Point c is added to Clause 2 Article 12 as
follows:
“c) The pharmacy shall provide explanation
about the unconformity or failure to submit explanatory report on its failure
to submit an application for periodic inspection as requested by the Provincial
Department of Health.”
10. The phrase “số hiệu đơn thuốc” (“the
prescription’s reference number") at Point b Clause 4 Section II of
Appendix I-1a is abrogated.
11. The phrase “Đối với thuốc gây nghiện, thuốc tiền
chất, thuốc hướng thần, thuốc dạng phối hợp có chứa dược chất gây nghiện, dược
chất hướng thần, tiền chất” (“With regard to narcotic drugs, precursors,
psychotropic drugs, and combined drugs that contain narcotic active
ingredients, psychotropic active ingredients or precursors”) at Point b Clause
4 Section II of Appendix I-1b shall be replaced by the phrase “Đối với thuốc dạng
phối hợp có chứa dược chất gây nghiện, dược chất hướng thần” (“With regard to
combined drugs that contain narcotic active ingredients or psychotropic active
ingredients”).
12. Point d Clause 3 Section III of Appendix I-1a
is amended as follows:
“d) Controlled drugs (narcotic drugs, psychotropic
drugs and precursors) and other toxic and/or dangerous drugs as well as drugs
associated with increased risk of overuse or causing fire or combustion (such
as liquid and solid substances which are ignitable or flammable, and compressed
air) must be stored at separate areas in which safety and security measures
must be implemented in accordance with regulations of law.”
13. Point d Clause 3 Section III of Appendix I-1b
is amended as follows:
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14. The 11th paragraph Point b Clause 4
Section III of Appendix I-1a is amended as follows:
“+ If the chief pharmacist is absent for more than
180 days, the drugstore must apply for a new certificate of eligibility for
pharmacy business. The drugstore shall continue its operations only after
obtaining a new certificate of eligibility for pharmacy business”.
15. The 10th paragraph Point b Clause 4
Section III of Appendix I-1b is amended as follows:
“+ If the chief pharmacist is absent for more than
180 days, the dispensary must apply for a new certificate of eligibility for
pharmacy business. The dispensary shall continue its operations only after
obtaining a new certificate of eligibility for pharmacy business”.
16. The 3rd paragraph Point dd Clause 5
Section III of Appendix I-1c is amended as follows:
“- If the chief pharmacist is absent for more than
180 days, the drug counter must apply for a new certificate of eligibility for
pharmacy business. The drug counter shall continue its operations only after obtaining
a new certificate of eligibility for pharmacy business”.
17. The note in Appendix II-2a is amended as
follows:
“If a drugstore does not yet start its business, it
shall be assessed according to indicators marked (*)”.
18. The following note is added to Appendix II-2b
and Appendix II-2c as follows:
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19. The mark “(*)” is added to the indicator “It is
equipped with temperature data loggers with a predetermined periodicity” at
Point 3.1.1 Appendix II-2b.
20. The phrase “điểm không chấp nhận”
(“non-compliance points”) is added to the column “Điểm trừ” (“Minus point”) at
Point 6.2 Appendix II-2a, Appendix II-2b and Point 5.3 Appendix II-2c.
21. The phrase “...thuốc gây nghiện, thuốc hướng thần,
thuốc tiền chất” (“…narcotic drugs, psychotropic drugs, precursors”) at Point
5.3.1, Point 5.3.2 and Point 7.9 of Appendix II-2b is replaced by the phrase
“...thuốc dạng phối hợp có chứa dược chất gây nghiện, dược chất hướng thần”
(“…combined drugs that contain narcotic or psychotropic active ingredients”).
22. Point 6.5 of Appendix II-2c is amended as
follows:
“It must have a firmly locked separate area or
cabinet for storing combined drugs that contain narcotic or psychotropic active
ingredients”.
23. The phrase “Quan sát thực tế” (“Actual
observation”) at Point 1.2.3 of Appendix II-2a is replaced by the phrase “Kiểm
tra hồ sơ nhân viên” (“Examination of employee dossiers”).
24. Point 1.2.4 of Appendix II-2a, Point 1.2.4 of
Appendix II-2b, Point 1.2.4 of Appendix II-2c are amended as follows:
“All pharmacists wear healthcare blouses and
nameplates indicating their professional titles, including the chief
pharmacist”.
25. The phrase “Tất cả nhân viên luyện để hiểu rõ
và thực hiện đúng các được huấn nguyên tắc GPP” at Point 1.2.6 of Appendix
II-2a and Point 1.2.5 of Appendix II-2b is replaced by the phrase “Tất cả nhân
viên được huấn luyện để hiểu rõ và thực hiện đúng các tiêu chuẩn GPP” (“All
employees must be trained to clearly understand and comply with the GPP
standards”).
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Article 2. Effect
This Circular comes into force after 45 days from the
date of promulgation.
Difficulties that arise during the implementation
of this Circular should be promptly reported to the Ministry of Health for
consideration./.
PP. MINISTER
DEPUTY MINISTER
Truong Quoc Cuong