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THE
MINISTRY OF HEALTH
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THE
SOCIALIST REPUBLIC OF VIETNAM
Independence– Freedom – Happiness
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No.:
15/2011/TT-BYT
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Ha
Noi, April 19, 2011
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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
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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
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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
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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.
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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.
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- 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.
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- 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
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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
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PP.
MINISTRY
DEPUTY MINISTER
Cao Minh Quang