Circular No. 12/2020/TT-BYT dated June 22, 2020 on providing amendments to the Circular No. 02/2018/TT-BYT on good pharmacy practice

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.

Article 1. Amendments to Circular No. 02/2018/TT-BYT dated January 22, 2018 of Minister of Health on good pharmacy practice

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:

“1. If the inspection report indicates that the pharmacy fulfils the GPP requirements as prescribed in Point a Clause 3 Article 7 hereof:

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:

“5. If the pharmacy fails to submit an application for periodic inspection within 45 days from the deadline for submission of the application for periodic inspection, the Provincial Department of Health shall conduct an ad hoc inspection of maintenance of fulfillment of the GPP requirements as prescribed in Article 12 hereof.”

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:

“d) Controlled drugs (combined drugs that contain narcotic or psychotropic active ingredients) 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 separately and protected by safety and security measures in accordance with regulations of law.”

14. The 11^th 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 10^th 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 3^rd 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:

“Note:  If a dispensary or dispensing counter does not yet start its business, it shall be assessed according to indicators marked (*)”.

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”).

26. Form No. 04 – Report on changes is added in Appendix III of this Circular.

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./.