Circular No. 15/2011/TT-BYT on the organization and operation of retail drug outlets in hospitals

CIRCULAR

Regulations on the organization and operation of retail drug outlets in hospitals

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Pursuant to the Medicine Law No. 34/2005-QH11 dated June 14, 2005;

Pursuant to the Government's Decree No. 188/2007/NĐ-CP dated December 27, 2007 on the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to Resolution No. 71/2006/QH11 of the National Assembly dated November 29, 2006 approving the Protocol for Accession to the World Trade Organization (WTO) Agreement;

Pursuant to the Government's Decree No. 43/2006/NĐ-CP dated April 25, 2006 on the rights to self-management and self-responsibility for the performance of tasks, organizational structure, staffing, and finance for public service units;

The Ministry of Health hereby stipulates regulations on the organization and operation of retail drug outlets in hospitals as follows:

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation and Applicability

This Circular stipulates the organization and operation of retail drug outlets in hospitals.

This Circular applies to individuals and organizations within and outside Vietnam that engage in activities related to the retail sale of drugs in hospitals.

Article 2. Interpretation of Terms

In this Circular, the following terms are understood as follows:

1. A retail drug outlet in a hospital (hereinafter referred to as a retail drug outlet) is a retail drug outlet located within the hospital premises organized in the forms of a pharmacy, a drug counter, or a specialized retail drug outlet selling traditional medicine and herbal drugs.

2. Finished drugs are drug products that have undergone all stages of production, including final packaging and labeling.

Chapter II

REGULATIONS ON THE ORGANIZATION AND OPERATING CONDITIONS OF RETAIL DRUG OUTLETS

Article 3. Regulations on the organization of retail drug outlets

1. For hospitals under the Ministry, provincial-level hospitals (hereinafter referred to as provincial hospitals), except for provincial-level mental health hospitals, convalescent hospitals, and rehabilitation hospitals: The hospital director must organize the retail drug outlet themselves. The hospital director is responsible for the operation (including financial assurance) of the retail drug outlet.

2. For provincial-level mental health hospitals, convalescent hospitals, and rehabilitation hospitals; hospitals under the Sector; district-level hospitals, urban district hospitals, and city town hospitals (hereinafter referred to as district hospitals), including district health centers where there is no separate district general hospital; regional general hospitals; regional specialized hospitals: It is encouraged for hospitals to organize their own retail drug outlets. The hospital director or district health center director is responsible for the operation (including financial assurance) of the retail drug outlet.

In cases where it is not possible to organize a retail drug outlet, the hospital may form joint ventures or partnerships with pharmaceutical businesses or individuals to establish a retail drug outlet to ensure adequate drug supply for patients. The business director or individual involved in the joint venture or partnership shares responsibility with the hospital director or district health center director for the operation of the retail drug outlet. The hospital director, district health center director, business director, or individual involved in the joint venture or partnership is responsible for ensuring the operational funding of the retail drug outlet in accordance with the provisions of the Government's Decree No. 43/2006/NĐ-CP dated April 25, 2006 on the rights to self-management and self-responsibility for the performance of tasks, organizational structure, staffing, and finance for public service units and relevant regulations.

3. Foreign-invested hospitals are not allowed to open their own retail drug outlets or form joint ventures or partnerships to establish retail drug outlets, except in cases approved by the Government for pilot implementation. To ensure drug supply for patients, the hospital creates conditions for pharmaceutical businesses or individuals to organize retail drug outlets in compliance with Vietnamese laws.

Article 4. Provisions on the operating conditions of retail drug outlets

1. Retail drug outlets must have a Certificate of Eligibility for Drug Business issued in accordance with Circular 02/2007/TT-BYT dated January 24, 2007 of the Ministry of Health detailing the implementation of certain provisions on drug business conditions under the Medicine Law and Decree 79/2006/NĐ-CP dated August 9, 2006 of the Government detailing the implementation of certain provisions of the Medicine Law.

In cases where retail drug outlets organized by hospitals cannot obtain a Business Registration Certificate, the Department of Health shall report to the People's Committee of the province or centrally-administered city for instructions to relevant authorities to consider and create conditions for such retail drug outlets to obtain a Business Registration Certificate to complete the procedures for obtaining a Certificate of Eligibility for Drug Business.

2. Retail outlets selling traditional medicine and herbal drugs must have physical facilities, technical equipment, and personnel applying Good Pharmacy Practice principles and standards according to the schedule set out in Clause 3, Section I, Chapter III of the Good Pharmacy Practice principles and standards promulgated together with Decision 11/2007/QĐ-BYT dated January 24, 2007.

Chapter III

PROVISIONS ON THE OPERATIONS OF RETAIL DRUG OUTLETS

Article 5. Scope of professional activities of retail drug outlets

1. Pharmacies and drug counters: sell finished pharmaceutical products permitted for circulation in Vietnam.

2. Pharmacies may compound drugs based on prescriptions at the pharmacy (if there is a compounding arrangement) and sell compounded hospital drugs.

3. Retail outlets selling traditional medicine and herbal drugs: sell traditional medicine and herbal drugs.

4. Purchase or entrust importation of drugs to meet the treatment needs of hospitals.

5. The list of drugs at retail drug outlets must comply with the drug list for patient treatment published by the Hospital Medicines and Treatment Council.

Article 6. Provisions on professional activities of retail drug outlets

1. The hospital pharmacy department advises the hospital director to implement professional regulations on medicines of retail drug outlets within the hospital.

2. Based on the actual conditions of the hospital, retail drug outlets arrange drug sales by shifts to ensure drug supply to patients including outside regular working hours, holidays, and weekends.

3. Retail drug outlets must display drug prices in accordance with Joint Circular No. 11/2007/TTLT-BYT-BTC-BCT dated August 31, 2007 of the Ministry of Health, Ministry of Finance, and Ministry of Industry and Trade guiding the state management of drug prices for use by people and must not sell at prices higher than the displayed price.

4. The retail price at retail drug outlets includes the purchase price recorded on the invoice and the retail markup; the retail price must not be higher than the market price of similar drugs (drugs with the same name, dosage form, manufacturer, and country of manufacture).

a) For drug items included in the hospital’s tender list: The purchase price of drugs by retail drug outlets must not be higher than the winning bid price at the same time.

b) For drug items not included in the hospital’s tender list or drug items for which suppliers refuse to sell at the winning bid price due to market price fluctuations being higher than the winning bid price: The hospital director decides and is responsible for the drug list and purchase price.

When purchasing the above items, the hospital requires enterprises to provide wholesale prices declared or re-declared to the competent state agency managing drug prices (the Drug Administration or the Department of Health) for verification and must not purchase drugs with wholesale prices higher than the declared or re-declared prices or those that have not completed the price declaration process in accordance with regulations.

5. The Ministry of Health stipulates the maximum retail markup for finished pharmaceutical products at retail drug outlets as follows:

a) For retail drug outlets at hospitals directly under the Ministry, hospitals with foreign investment capital participating in pilot programs, provincial-level hospitals excluding provincial mental health, convalescent, and rehabilitation hospitals:

- For drugs with a purchase price calculated per smallest unit package not exceeding 1,000 VND, the maximum retail markup is 15%.

- For drugs with a purchase price calculated per smallest unit package from over 1,000 VND to 5,000 VND, the maximum retail markup is 10%.

- For drugs with a purchase price calculated per smallest unit package from over 5,000 VND to 100,000 VND, the maximum retail markup is 7%.

- For drugs with a purchase price calculated per smallest unit package from over 100,000 VND to 1,000,000 VND, the maximum retail markup is 5%.

- For drugs with a purchase price calculated per smallest unit package over 1,000,000 VND, the maximum retail markup is 2%.

b) For provincial-level mental health, convalescent, and rehabilitation hospitals; hospitals directly under the Health Sector; district-level general hospitals including district health centers without separate district general hospitals; regional general hospitals; regional specialized hospitals:

- For drugs with a purchase price calculated per smallest unit package not exceeding 1,000 VND, the maximum retail markup is 20%.

- For drugs with a purchase price calculated per smallest unit package from over 1,000 VND to 5,000 VND, the maximum retail markup is 15%.

- For drugs with a purchase price calculated per smallest unit package from over 5,000 VND to 100,000 VND, the maximum retail markup is 10%.

- For drugs with a purchase price calculated per smallest unit package from over 100,000 VND to 1,000,000 VND, the maximum retail markup is 7%.

- For drugs with a purchase price calculated per smallest unit package over 1,000,000 VND, the maximum retail markup is 5%.

The smallest unit package is defined as follows:

- For solid dosage forms, the smallest unit package is the tablet.

- For liquid dosage forms, the smallest unit package is the vial, bottle, bag, prefilled syringe, or prefilled cylinder.

- For powder for injection dosage forms, the smallest unit package is the vial, bottle, prefilled syringe.

- For powder or granule for oral suspension dosage forms, the smallest unit package is the packet, bottle.

- For topical cream, ointment, or gel dosage forms, the smallest unit package is the tube or bottle.

- For transdermal patch dosage forms, the smallest unit package is the patch.

- For pharmaceutical preparations in the form of sprays or inhalers, the smallest unit of packaging is a spray bottle or a container for use with an inhaler machine.

- For pharmaceutical preparations in the form of combination kits, the smallest unit of packaging is a kit.

6. Retail pharmacies must strictly comply with Decision No. 04/2008/QD-BYT dated February 1, 2008 on Prescription Regulations for Outpatient Treatment and Circular No. 08/2009/TT-BYT dated July 1, 2009 on the List of Non-Prescription Drugs.

Chapter IV

IMPLEMENTATION

Article 7. Transitional Provisions

1. From the date this Circular takes effect, hospitals under the Ministry and provincial-level hospitals currently organizing retail pharmacies through joint ventures or partnerships are encouraged to switch to the form of self-organizing retail pharmacies.

2. Retail pharmacies organized through joint ventures or partnerships at the hospitals mentioned in Clause 1 of this Article, excluding provincial-level mental health, convalescent, and rehabilitation hospitals, which have obtained a Business Condition Certificate before the effective date of this Circular, may continue operations until the expiration date of their Business Condition Certificate.

Article 8. Inspection and Audit

1. The Drug Administration Department and the Inspectorate of the Ministry of Health shall organize inspections and audits of the implementation of this Circular within their respective jurisdictions concerning retail pharmacies.

2. Provincial Departments of Health shall be responsible for inspecting and auditing the implementation of this Circular within their jurisdictional areas.

Chapter V

IMPLEMENTING PROVISIONS

Article 9. Effective Date

1. This Circular takes effect from June 10, 2011. Decision No. 24/2008/QD-BYT dated July 11, 2008 of the Ministry of Health on the organization and operation of hospital pharmacies is hereby repealed.

2. During the implementation process, if there are difficulties or obstacles, retail establishments and individuals are requested to provide written comments to the Ministry of Health (Drug Administration Department) for consideration and resolution./.