Circular No. 12/2020/TT-BYT Issuing the Circular amending and supplementing Circular No. 02/2018/TT-BYT dated January 22, 2018 of the Minister of Health on Good Pharmacy Practice.

 

CIRCULAR

AMENDMENTS AND SUPPLEMENTS TO CERTAIN ARTICLES OF CIRCULAR NO. 02/2018/TT-BYT OF JANUARY 22, 2018, ISSUED BY THE MINISTER OF HEALTH ON GOOD PRACTICE FOR RETAIL PHARMACIES

Pursuant to Law No. 105/2016/QH13 dated April 6, 2016 on pharmaceuticals;

Pursuant to the Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government detailing some provisions and measures for implementing the Medicine Law;

Pursuant to the Decree No. 155/2018/NĐ-CP dated November 12, 2018 of the Government amending and supplementing certain regulations related to investment and business conditions within the scope of management of the Ministry of Health;

Pursuant to the Government's Decree No. 75/2017/NĐ-CP dated June 20, 2017 stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Drug Administration Department, Ministry of Health,

The Minister of Health issues this Circular amending and supplementing Circular No. 02/2018/TT-BYT dated January 22, 2018 of the Minister of Health on good practice for retail pharmacies.

Article 1. Amending and supplementing certain articles of Circular No. 02/2018/TT-BYT dated January 22, 2018 of the Minister of Health on good practice for retail pharmacies

1. Clause 1, Article 5 shall be amended as follows:

"The dossier serving as the basis for evaluating compliance with GPP for retail pharmacies is the application dossier for the Pharmaceutical Business License (which is submitted when applying for the Pharmaceutical Business License, retail pharmacies do not need to submit additional dossiers for GPP evaluation) in accordance with Article 38 of the Pharmaceutical Law and Article 32 of Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government detailing some provisions and measures to implement the Pharmaceutical Law (hereinafter referred to as Decree No. 54/2017/NĐ-CP). For retail pharmacies subject to special control, they must comply with the provisions of Article 38 of the Pharmaceutical Law, Article 49 of Decree No. 54/2017/NĐ-CP and Clause 31 of Article 5 of Decree No. 155/2018/NĐ-CP dated November 12, 2018 of the Government amending and supplementing certain regulations related to investment and business conditions under the management of the Ministry of Health (hereinafter referred to as Decree No. 155/2018/NĐ-CP)."

2. Clause 2, Article 6 shall be amended as follows:

"2. Procedures for receiving and examining the dossier: Implemented in accordance with Clause 2 and Clause 5 of Article 33, Article 49 of Decree No. 54/2017/NĐ-CP and Clause 12 of Article 5 of Decree No. 155/2018/NĐ-CP."

3. Point đ, Clause 1, Article 7 shall be amended as follows:

"đ) Step 5. Draft and sign the minutes:

The inspection team is responsible for drafting the Good Practice Evaluation Minutes according to Model No. 02 stipulated in Appendix III attached hereto; the minutes must classify the level of compliance with GPP of the retail pharmacy according to Clause 2 and Clause 3 of this Article and list and analyze the deficiencies that the retail pharmacy needs to rectify (if any); compare the provisions of the checklist with the corresponding scores based on the type of retail pharmacy, and unify and reconcile the contents between the inspection team and the retail pharmacy.

The Good Practice Evaluation Minutes must be signed and confirmed by the Head of the Retail Pharmacy and the Leader of the Inspection Team. The minutes must reflect the members of the inspection team, location, time, scope of the evaluation, and be drafted in two copies: one copy retained at the retail pharmacy, one copy retained at the Department of Health."

4. Clause 1, Article 8 shall be amended as follows:

"1. In the case where the GPP inspection report concludes that the retail drug outlet complies with GPP as stipulated in Point a of Clause 3 of Article 7 of this Circular:

Within ten days from the date of completion of the actual evaluation at the retail pharmacy and signing the evaluation minutes, the Department of Health shall issue the Pharmaceutical Business License and/or the GPP Certificate according to Model No. 03 stipulated in Appendix III attached hereto."

5. Point a and point c, Clause 2, Article 8 shall be amended as follows:

"a) Within five days from the date of completing the actual evaluation at the facility and signing the evaluation minutes, the Department of Health shall send a letter requesting the retail pharmacy to rectify and repair the deficiencies recorded in the evaluation minutes;

c) Within twenty days from the date of receipt of the report on rectification, the Department of Health shall evaluate the results of rectification by the retail pharmacy and conclude on the status of compliance with GPP of the retail pharmacy:

- In case the rectification by the retail pharmacy meets the requirements, the Department of Health shall issue the Pharmaceutical Business License and/or the GPP Compliance Certificate according to Model No. 03 stipulated in Appendix III attached hereto;

- In case the rectification by the retail pharmacy does not meet the requirements, the Department of Health shall issue a reply stating the reasons for non-issuance."

"4. In case the retail pharmacy fails to submit the periodic evaluation application dossier within the deadline stipulated in Clause 3 of this Article, within fifteen days from the due date of submission of the periodic evaluation application dossier, the Department of Health shall issue a notice requiring the retail pharmacy to submit the periodic evaluation application dossier."

"5. Within forty-five days from the due date of submission of the periodic evaluation application dossier, if the retail pharmacy fails to submit the periodic evaluation application dossier after this period, the Department of Health shall conduct an unscheduled inspection and supervision of the maintenance of GPP compliance of the facility in accordance with Article 12 of this Circular."

"7a. The retail pharmacy shall submit one set of the periodic evaluation application dossier for maintaining GPP compliance along with the examination fee as prescribed by the Ministry of Finance regarding the examination fee for retail drug sale conditions and standards to the Department of Health."

"c) The retail pharmacy provides explanations for non-compliance or fails to submit a report explaining the reasons for not submitting the periodic evaluation application dossier as required by the Department of Health."

10. Delete the phrase "prescription number" in Point b, Clause 4, Part II, Appendix I-1a.

12. Point d, Clause 3, Part III, Appendix I-1a shall be amended as follows:

"d) Narcotic drugs (including narcotics, psychotropics, and precursors) and other hazardous and/or dangerous drugs, as well as drugs with a high risk of abuse, such as flammable liquids, combustible solids, and compressed gases, must be stored in separate areas with safety and security measures in accordance with the law."

13. Point d, Clause 3, Part III, Appendix I-1b shall be amended as follows:

"d) Special controlled drugs (combination drugs containing addictive substances, psychotropic substances), and other harmful and/or dangerous drugs, as well as drugs with a special risk of abuse, causing fire and explosion (such as flammable liquids and solids, compressed gases) must be stored separately, with safety and security measures in accordance with the provisions of the law."

14. Paragraph 11, Point b, Clause 4, Section III, Annex I-1a shall be amended as follows:

"+ If the absence period exceeds 180 days, the establishment must apply for a new business license for retail drug sales. The establishment may only operate once it has been issued a new Business License."

15. Paragraph 10, Point b, Clause 4, Section III, Annex I-1b shall be amended as follows:

"+ If the absence period exceeds 180 days, the establishment must apply for a new business license for retail drug sales. The establishment may only operate once it has been issued a new Business License."

16. Paragraph 3, Point d, Clause 5, Section III, Annex I-1c shall be amended as follows:

"- If the absence period exceeds 180 days, the establishment must apply for a new business license for retail drug sales. The establishment may only operate once it has been issued a new Business License."

17. The Note to Annex II-2a shall be amended as follows:

"For establishments that have not yet commenced business operations, only criteria marked with (*) shall be evaluated."

18. Add the following Note to Annex II-2b and Annex II-2c:

"Note: For establishments that have not yet commenced business operations, only criteria marked with (*) shall be evaluated."

19. Add the symbol "(*)" to the content "Having temperature recording equipment with appropriate frequency" at Point 3.1.1, Annex II-2b.

20. Add the phrase "non-acceptance point" in the "Deduction Points" column of Point 6.2, Annex II-2a, Annex II-2b, and Point 5.3, Annex II-2c.

21. Replace the phrase "...narcotic drugs, psychotropic drugs, precursor drugs" with the phrase "...combination drugs containing addictive substances, psychotropic substances" at Point 5.3.1, Point 5.3.2, and Point 7.9, Annex II-2b.

22. Point 6.5, Annex II-2c shall be amended as follows:

"There is a separate area or locked cabinet for storing combination drugs containing addictive substances, psychotropic substances."

23. Replace the phrase "On-site observation" with the phrase "Employee file review" at Point 1.2.3, Annex II-2a.

24. Point 1.2.4, Annex II-2a, Point 1.2.4, Annex II-2b, Point 1.2.4, Annex II-2c shall be amended as follows:

"Wearing blue shirts and name badges clearly indicating their positions, including the person in charge of professional matters."

25. Replace the phrase "All employees are trained to understand and properly implement the GPP principles" with the phrase "All employees are trained to understand and properly implement the GPP standards" at Point 1.2.6, Annex II-2a, Point 1.2.5, Annex II-2b.

26. Add Form No. 04 regarding change reports attached to this Circular at Annex III.

Article 2. Effective Date.

This Circular takes effect 45 days from the date of issuance.

During implementation, if there are difficulties or obstacles, please report them to the Ministry of Health for consideration and resolution./.