Thông tư 15/2011/TT-BYT

CIRCULAR

REGULATIONS ON ORGANIZATION AND OPERATION OF DRUG RETAIL ESTABLISHMENT

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

Pursuant to the Decree No.188/2007/ND-CP dated December 27, 2007 of the Government stipulating the functions, duties, powers and organizational structure of the Ministry of Health;

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

Pursuant to the Decree No.43/2006/ND-CP dated April 25, 2006 of the Government providing for the right of public non-business units to autonomy and accountability for task performance, organizational apparatus, payroll and finance;

The Ministry of Health stipulates the organization and operation of drug retail establishment in hospitals as follows:

Chapter I

GENERAL PROVISIONS

Article 1. Scope of adjustment and subjects for application

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

This Circular is applicable to organizations, individuals domestic and in foreign country carrying out the activities relating to the drug retail in hospitals;

Article 2. Explanation of term

In this Circular, the terms below are construed as follows:

1. Drug retail establishment in hospital (hereinafter referred to as drug retail establishment for short) means the drug retail establishment in hospital organized in the forms: a pharmacy, drug counter or drug retail establishment specialized in selling oriental medicine drug, drug from medicinal material.

2. Finished drug is a form of drug that have gone through all stages of production, including packing in the final packaging and labeling.

Chapter II

REGULATION ON ORGANIZATION AND OPERATION CONDITION OF DRUG RETAIL ESTABLISHMENT

Article 3. Regulation on organization of drug retail establishment

1. For hospitals directly under the Ministry, central-affiliated provincial/municipal hospitals (hereinafter referred to as provinces for short) except for the provincial hospitals specialized in mental, nursing and rehabilitation: The directors of hospitals must organize drug retail establishments by themselves. The directors of hospitals must take responsibility for the operation (including fund assurance) of the drug retail establishments.

2. For the provincial hospitals specialized in mental, nursing and rehabilitation; hospitals under the Health Sector; district and town hospitals (hereinafter referred to as districts for short) including the district Health centers where there is no the particular district general hospitals; area general hospitals; area specialized hospitals: encouraging hospitals to organize drug retail establishments by themselves. The directors of hospitals, directors of district health centers are responsible for the activities (including fund assurance) of the drug retail establishments.

In case failing to organize drug retail establishments by themselves, hospitals can cooperate and associate with drug trading enterprises or individuals to organize retail drug establishments to ensure adequate supply of drug to patients. The directors of trading enterprises or individuals joining venture and associating will jointly take responsibility with the directors of hospitals or the director of district health centers for the activities of drug retail establishments. The directors of hospitals, directors of district health centers, directors of trading enterprises or individuals joining venture and associating will take responsibility for ensuring operational fund of drug retail establishments in conformity with the provisions in Decree No. 43/2006/ND-CP dated April 25, 2006 of the Government providing for the right of public non-business units to autonomy and accountability for task performance, organizational apparatus, payroll and finance and relevant provisions

3. The hospitals with the foreign invested capital are not entitled to open their own drug retail establishments, not entitled to join venture and associate in order to set up drug retail establishments, except for the case as permitted by the Government to deploy for pilot. In order to ensure the supply of drug to patients, the hospitals should facilitate the drug trading enterprises or individuals to organize the drug retail establishments in accordance with the provisions of Vietnamese law.

Article 4. Regulations on operational conditions of retail drug establishments

1. The drug retail establishments must have Certificate of eligibility for drug trading as prescribed in the Circular No. 02/2007/TT-BYT dated January 24, 2007 of the Ministry of Health guiding the implementation of a number of articles on the conditions of drug trading as prescribed of the Pharmacy Law and the Decree No.79/2006/ND-CP dated August 09, 2006 of the Government stipulating in detail the implementation of a number of articles of the Pharmacy Law.

In case the drug retail establishments organized by hospitals cannot own Certificates of business registration, the Service of Health will make a report to the People’s Committees of central-affiliated provinces and cities in order to direct the competent agencies for consideration and facilitation for the drug retail establishments to own Certificates of business registration in order to carry out the procedures for granting the Certificates of eligibility for drug trading.

2. The retail establishments of oriental medicine drugs and drugs from medicinal materials must have material and technical facility and personnel to apply the principle and standard “Good Pharmacy Practice” according to the roadmap prescribed in clause 3, Section 1, Chapter III of the principle and standard “Good Pharmacy Practice” promulgated together with the Decision No.11/2007/QD-BYT dated January 24, 2007.

Chapter III

REGULATION ON OPERATION OF DRUG RETAIL ESTABLISHMENTS

Article 5. Professional operational scope of the drug retail establishments

1. Pharmacies and drug counters: Retailing finished drugs permitted for circulation in Vietnam.

2. Pharmacies are entitled to prepare under the hospital prescription at pharmacies (if activity of preparation under prescription arranged) and retail prepared drug of the hospitals.

3. The retail establishments of oriental medicine drugs and drugs from medicinal materials: retailing oriental medicine drugs and drugs from medicinal materials.

4. Purchasing or authorized import of drugs to serve the treating demand of hospitals

5. Lists of drugs at the drug retail establishments must meet the lists of drugs treating for patients announced by the Drug and Treatment Council of hospitals

Article 6. Regulations on professional operation of drug retail establishments

1. The pharmacy departments of hospitals will advise the hospitals directors to carry out professional regulations on pharmacy of the drug retail establishments at the hospitals.

2. Based on the actual conditions of the hospitals, the drug retail establishments will arrange for the sale of drug by shift including outside working hours, on holidays and days-off in order to ensure drug supply for patients.

3. The drug retail establishments will perform the listing of drug prices as prescribed in the Joint Circular No. 11/2007/TTLT-BYT-BTC-BCT dated August 31, 2007 of Inter Ministry of Health – Finance – Industry and Trade guiding the implementation of state management on the price of drugs used for human and not selling at prices higher than the listed prices.

4. The retail price at the drug retail establishments includes the purchase price stated on invoice and retail surplus; the retail price must not be higher than the price of the same type of drug in the market (drugs with the same name, content, dosage, form of preparation, producing company and country).

a) For drug items in the bidding list of hospitals: price of purchased drugs of the retail establishments must not be higher than the price winning bid at the same time.

b) For drug items not in the bidding list of hospitals or the drug items that the providers refuse to sell with the winning bid price due to the fluctuation in market price higher than the winning bid price: The hospitals directors will decide and take responsibility for the drug list and price of purchases drugs.

Upon purchasing the items above mentioned, the hospitals will require the enterprises to supply the declared wholesale price or to re-declare with the state management agencies on drug price (Drug Administration or Service of Health) for checking. Do not purchase the drugs with the wholesale prices higher than that declared, re-declared or not conducting the declaration of drug price as prescribed.

5. The Ministry of Health will specify the maximum retail surplus of finished drugs at the drug retail establishments as follows:

a) For the drug retail establishments at the hospitals under the Ministry, the hospitals with foreign invested capital are permitted for pilot application; the provincial hospitals except for the provincial hospitals specialized in mental, nursing and rehabilitation:

- For drugs with the purchase price calculated on the smallest packaging unit less than or equal to VND 1,000, the retail surplus is 15% maximumly.

- For drugs with the purchase price calculated on the smallest packaging unit between VND 1,000 and 5,000, the retail surplus is 10% maximumly.

- For drugs with the purchase price calculated on the smallest packaging unit between VND 5,000 and 100,000, the retail surplus is 7% maximumly.

- For drugs with the purchase price calculated on the smallest packaging unit between VND 100,000 and 1,000,000, the retail surplus is 5% maximumly.

- For drugs with the purchase price calculated on the smallest packaging unit over VND 1,000,000, the retail surplus is 2% maximumly.

b) For the provincial hospitals specialized in mental, nursing and rehabilitation hospitals; hospitals under the Health Sector; district hospitals including district Health centers where there is no the particular district general hospital; area general hospitals; area specialized hospitals:

- For drugs with the purchase price calculated on the smallest packaging unit less than or equal to VND 1,000, the retail surplus is 20% maximumly.

- For drugs with the purchase price calculated on the smallest packaging unit between VND 1,000 and 5,000, the retail surplus is 15% maximumly.

- For drugs with the purchase price calculated on the smallest packaging unit between VND 5,000 and 100,000, the retail surplus is 10% maximumly.

- For drugs with the purchase price calculated on the smallest packaging unit between VND 100,000 and 1,000,000, the retail surplus is 7% maximumly.

- For drugs with the purchase price calculated on the smallest packaging unit over VND 1,000,000, the retail surplus is 5% maximumly.

c) The smallest packaging unit is specified as follows:

- For the form of preparation is pill, the smallest packaging unit is pill.

- For the form of preparation is liquid, the smallest packaging unit is ampoule, bottle, vial, phial, sachet, syringe, prefilled-drug syringe.

- For the form of preparation is powder for injection, the smallest packaging unit is ampoule, bottle, vial, phial, prefilled-drug syringe.

- For the form of preparation is oral powder, granular, the smallest packaging unit is sachet, bottle, vial.

- For the form of preparation is cream, ointment, gel for external use, the smallest packaging unit is tube and vial.

- For the form of preparation is adhesive plaster, the smallest packaging unit is plaster

- For the form of preparation is sprays or aerosol, the smallest packaging unit is spray bottles or vials of drugs for aerosol machine.

- For the form of preparation is combined kit set, the smallest packaging unit is kit set

6. The drug retail establishments must strictly comply with the Decision No. 04/2008/QD-BYT dated February 01, 2008 on Regulation on drug prescription in outpatient treatment and the Circular No. 08/2009/TT-BYT dated July 01, 2009 promulgating the list of non- prescription drugs.

Chapter IV

IMPLEMENTATION ORGANIZATION

Article 7. Transitional provision

1. Form the date this Circular takes effect, the hospitals directly under the Ministry, provincial hospitals organizing the drug retail establishments in the joint-venture and associated form are encouraged to transform to the form of self-organization of drug retail establishments.

2. The drug retail establishments that have been organized in the joint-venture and associated form at the hospitals mentioned in clause 1 of this Article except for the provincial hospitals specialized in mental, nursing and rehabilitation and already owned the Certificate of eligibility for drug trading before the date this Circular takes effect are entitled to operate until the expiration of this Certificate of eligibility for drug trading.

Article 8. Examination and Inspection

1. The Drug Administration and Inspector of Ministry of Health will organize the examination and Inspection of the implementation of this Circular under the competence regarding to drug retail establishments

2. The Service of Health of central-affiliated provinces and cities are liable to examine and inspect the implementation of this Circular within their respective localities

Chapter V

EFFECT FOR IMPLEMENTATION

Article 9. Effect

1. This Circular takes effect on June 10, 2011. Annulling the Decision No. 24/2008/QD-BYT dated July 11, 2008 of the Ministry of Health promulgating regulations on organization and operation of hospital pharmacy

2. Any problem arising in the course of implementation should be promptly reported to the Ministry of Health (Drug Administration) for consideration and settlement.