Thông tư 12/2020/TT-BYT sửa đổi Thông tư 02/2018/TT-BYT thực hành tốt cơ sở bán lẻ thuốc

CIRCULAR

On amending and supplementing a number of Article of the Circular No. 02/2018/TT-BYT dated May 04, 2018 of the Minister of health on good pharmacy practices

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

Pursuant to the Government’s Decree No. 54/2017/ND-CP of May 8, 2017, detailing a number of articles of and providing measures for implementation of the Pharmacy Law;

Pursuant to the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 amending and supplementing a number of 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 prescribing the functions, tasks, powers and organizational structure of the Ministry of Health;

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

The Minister of Health hereby issues the Circular on amending and supplementing a number of Article of the Circular No. 02/2018/TT-BYT dated May 04, 2018 of the Minister of health on good pharmacy practices.

Article 1. On amending and supplementing a number of Article of the Circular No. 02/2018/TT-BYT dated May 04, 2018 of the Minister of health on good pharmacy practices

1. The first paragraph of Clause 1 Article 5 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 documents on good pharmacy practices 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”). For special control pharmacy, to implement as prescribed in Article 38 of the Law on Pharmacy, Article 49 of the Decree No. 54/2017/ND-CP and Clause 31 Article 5 of Decree No. 155/2018/ND-CP November 12, 2018 of the Government on amending and supplementing a number of regulations related to business conditions under the state management of the Ministry of Health (hereinafter referred to as the Decree No. 155/2018/ND-CP).

2. To amend Clause 2 Article 6 as follows:

“2. Order of dossier receipt and appraisal: Implement as prescribed in Clause 2 and Clause 5 of Article 33, Article 49 of the Decree No. 54/2017/ND-CP and Clause 12 Article of the Decree 155/2018/ND-CP.”

3. To amend point dd Clause 1 Article 7 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 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); agreement and 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 two copies, 01 of which shall be kept by the Provincial Department of Health and the other is kept by the applicant.”

4. To amend Clause 1 Article 8 as follows:

“1. If the inspection report indicates that the pharmacy complied 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 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.”

5. To amend point a and c of Clause 2 Article 8 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 correction actions against its deficiencies specified in the inspection report;

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 and/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.

6. To amend Clause 4 Article 9 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 the time limit of 15 days from the due date of periodic inspection submission, it is required to provide a written explanation as requested in writing by the Provincial Department of Health.”

7. To amend Clause 5 Article 9 as follows:

“5. Within 45 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 implement irregular inspection on GPP compliance of the pharmacy as prescribed in Article of this Circular.”

8. To supplement Clause 7a to Article 9 as follow:

“7a. The pharmacy shall submit 01 request dossier on periodic evaluation of GPP compliance with the charge of appraisal to the Provincial Department of Health in accordance with provisions of the Ministry of Finance on charge and fee of appraising condition and standards of drugs trading.”

9. To supplement Clause c to Clause 2 Article 12 as follow:

“c) The pharmacy explanation is unreasonable or the pharmacy fail to submit the explanation report on the reason of its failure to submit the application for periodic inspection as requested by the Provincial Department of Health.”

10. To eliminate the phrase of “prescription number” in point b Clause 4 of Section II in the Appendix No. I-1a.

11. To replace the phrase of “For addictive medicines, pre-substances, psychotropic medicines, combined medicines containing addictive substances, psychotropic medicines, pre-substances” by the phrase “For combined medicines containing addictive substances, psychotropic medicines” in point b Clause 4, Section II of the Appendix I-1b.

12. To amend point d Clause 3 Section III of the Appendix I-1a as follow:

“d) For special controlled drugs (addictive, psychotropic medicines and pre- substances) and other poisonous and/or dangerous medicines as well as medicine with high potential of abusive, inflammable, explosible (such as inflammable liquid and solid substances and compressed gas) must be stored in separate area with safety and security measurement in accordance with law provisions.”

13. To amend point d Clause 3 Section III of the Appendix I-1b as follow:

“d) For special controlled drugs (combined medicines containing addictive substances, psychotropic medicines) and other poisonous and/or dangerous medicines as well as medicine with high potential of abusive, inflammable, explosible (such as inflammable liquid and solid substances and compressed gas) must be stored in separate area with safety and security measurement in accordance with law provisions.”

14. To amend the eleventh paragraph of point b Clause 4 Section III of the Appendix I-1a as follow:

“+ In case the absence time longer than 180 days, the pharmacy must conduct the procedure on application for newly granted of Certificate of eligibility for pharmacy business. The pharmacy allowed to operate only after granted the new Certificate of eligibility for pharmacy business.”

15. To amend the tenth paragraph of point b Clause 4 Section III of the Appendix I-1b as follow:

“+ In case the absence time longer than 180 days, the pharmacy must conduct the procedure on application for newly granted of Certificate of eligibility for pharmacy business. The pharmacy allowed to operate only after granted the new Certificate of eligibility for pharmacy business.”

16. To amend the third paragraph of point dd Clause 5 Section III of the Appendix I-1c as follow:

“+ In case the absence time longer than 180 days, the pharmacy must conduct the procedure on application for newly granted of Certificate of eligibility for pharmacy business. The pharmacy allowed to operate only after granted the new Certificate of eligibility for pharmacy business.”

17. To amend the note of the Appendix Ii-2a as follow:

“For the pharmacy not yet operate, only carry out inspection for criteria with (*) mark.”

18. To supplement the Note for the Appendix II-2b and Appendix Ii-2c as follow:

“Note: “For the pharmacy not yet operate, only carry out inspection for criteria with (*) mark.”

19. To supplement the mark (*) for the content of “Having automatically recording temperature monitoring device with the right frequency” in point 3.1.1 in Appendix II-2b.

20. To supplement the phrase of “Refusal reason” in the Column of “Negative points” in point 6.2 of Appendix II-2a, Appendix II-2b and point 5.3 of Appendix II-2c.

21. To replace the phrase of “...addictive medicines, pre-substances, psychotropic medicines, pre- substances medicines” by the phrase “...combined medicines containing addictive substances, psychotropic medicines” in point 5.3.1, 5.3.2 and point 7.9 of Appendix II-2b.

22. To amend point 6.5 of the Appendix II-2c as follow:

“Having separate section or locker with safety lock to store combined medicines containing addictive substances, psychotropic medicines.”

23. To replace the phrase of “Practical observation” to “Employee dossier inspection” in point 1.2.3 of the Appendix II-2a.

24. To amend point 1.2.4 of the Appendix II-2a, Appendix II-2b, point 1.2.4 Appendix II-2c as follow:

“Wearing the white coat with name tag clearly state the title, including the specialized manager.”

25. To replace the phrase of “All the employee shall be thoroughly understanding and implement  trained to according to GPP principal” to “All the employee shall be trained to thoroughly understand and implement according to GPP principal” in point 1.2.3 of Appendix Ii-2a, point 1.2.5 of Appendix II-2b.

26. To supplement the form No. 04 on changing report in the Appendix No. III attached to this Circular.

Article 2. Effect

This Circular takes effect 45 days after the issuance date.

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

For the Minister

Deputy Minister

Truong Quoc Cuong