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THE
MINISTRY OF HEALTH
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SOCIALIST
REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
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No.
24/2008/QD-BYT
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Hanoi,
July 11, 2008
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DECISION
PROMULGATING
THE REGULATION ON ORGANIZATION AND OPERATION OF HOSPITAL PHARMACIES
THE MINISTER OF HEALTH
Pursuant to the Governments
Decree No. 188 2007/ND-CP of December 27, 2007, defining the functions, tasks,
powers and organizational stmcture of the Ministry of Health;
Pursuant to Pharmacy Law No. 34/2005-OH11 of June 14, 2005;
Pursuant to the Governments Decree No. 79/ 2006/ND-CP of August 9, 2006,
detailing the implementation of a number of articles of the Phannacy Law;
Pursuant to the Governments Decree No. 43/2006/ND-CP of April 25,2006,
providing for the right of public non-business units to autonomy and
accountability for task performance, organizational apparatus, payroll and
finance;
At the proposal of the director of the Drug Administration of Vietnam,
DECIDES:
Article 1.- To promulgate
together with this Decision the Regulation on organization and operation of
hospital pharmacies.
Article 2.-This Decision
takes effect 15 days after its publication in "CONG BAO."
Article 3.- The director
of the Office and the Chief Inspector of the Ministry, the director of the Drug
Administration of Vietnam, heads of units under the Ministry, directors of
provincial/ municipal Health Services, health agencies of branches and
directors of hospitals shall implement this Decision.
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FOR THE MINISTER
OF HEALTH
VICE MINISTER
Cao Minh Quang
REGULATION
ON
ORGANIZATION AND OPERATION OF HOSPITAL PHARMACIES
(Promulgated together with the Health Ministers Decision No. 24/2008/QD-BYT
of July 11, 2008)
For uniform management of drug
retail sale activities in hospitals and research institutes having patient beds
(below collectively referred to as hospitals) and in order to effectively serve
the protection, care and improvement of peoples health, the Ministry of Health
provides for the organization and operation of hospital pharmacies as follows:
I. PROVISIONS ON ORGANIZATION
1. Hospital pharmacy means a
drug retail sale establishment inside the area of a hospital organized in the
form of a pharmacy, drug stall or establishment retailing traditional medicines
or pharmaceutical material-based drugs. Drug stalls may only be opened in
hospitals in districts of provinces and centrally run cities.
2. Hospital directors shall take
responsibility for the operation of hospital pharmacies. When a hospital
pharmacy is a joint venture or association of the hospital, the director of the
unit or the individual entering the joint venture or association and the
hospital director shall take joint responsibility for the operation of the
hospital pharmacy.
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4. Every hospital pharmacy must
possess a certificate of eligibility for drug trading under die Health
Ministrys Circular No. 02/2007/TT-BYT of January 24,2007, detailing the implementation
of a number of articles on drug trading conditions under the Pharmacy Law and
the Governments Decree No. 79/2006/ND-CP of August 9, 2006, detailing the
implementation of a number of articles of the Pharmacy Law.
5. A hospital pharmacy must have
technical and material foundations and personnel satisfying Good Pharmacy
Practice principles and standards according to the following roadmap:
a/ For pharmacies:
- To satisfy Good Pharmacy
Practice principles standards as of January 1,2009.
- Newly established pharmacies
in inner-city districts and wards of Hanoi, Da Nang, Ho Chi Minh and Can Tho
cities must satisfy Good Pharmacy Practice standards.
b/ Drug stalls must satisfy Good
Pharmacy Practice principles and standards as of January 1, 2010.
c/ Establishments retailing
traditional medicines and pharmaceutical material-based drugs shall follow the
roadmap specified in Clause 3, Section I, Chapter III of Good Pharmacy Practice
principles and standards.
II. PROVISIONS ON OPERATION
1. Scope of professional
operations of a hospital pharmacy:
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b/ To retail a number of types
of specialized drugs prepared under the hospitals prescriptions (according to
the guidance specified at Item 4, Clause 2.1, Article 2 of the Drug
Registration Regulation promulgated together with the Health Ministers Decision
No. 3121/2001/QD-BYT of July 18, 2001).
c/ To procure or entrust the
import of drugs to meet the hospitals treatment requirements.
d/ The list of drugs at a
hospital pharmacy must fully contain required drugs as announced by the
hospitals Drug and Treatment Council.
2. A hospital pharmacy shall,
based on the hospitals actual conditions, sell drugs in shifts outside working
hours, on holidays and at weekends to ensure supply for patients.
3. A hospital pharmacy shall
post up drug prices according to Joint Circular No. 11/2007/ TTLT-BYT-BTC-BCT
of August 31, 2007, of the Ministry of Health, the Ministry of Finance and the
Ministry of Industry and Trade, guiding the state management of human drug
prices, and may not sell drugs at prices higher than the posted-up prices.
4. The retail price at a
hospital pharmacy includes the invoiced purchase price upon procurement of
goods (original price) and the retail surplus (rational retail expenses and
profits).
To stabilize the drug market and
ensure peoples healthcare needs, the Ministry of Health temporarily prescribes
the maximum retail surplus as follows:
No.
Drug
value based on original price of smallest packing unit
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1
Less than or equal to VND
1,000
207%
2
Over VND 1,000 to VND 5,000
15%
3
Over VND 5,000 to VND 100,000
10%
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Over VND 100,000 to VND
1,000,000
7%
5
Over VND 1,000,000
5%
The Ministry of Health may
adjust the examine hospital pharmacies according to maximum retail surplus in
each period suitable to law. market realities.
Smallest packing units are
specified as follows:
No.
Forms
of preparation
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1
Pill
Pill
2
Liquid
Phial, bottle, vial, ampoule
3.
Powder for injection
Phial, bottle, vial, ampoule
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Oral powder and granule
Sachet, bottle, vial
5
Cream, ointment, gel for
external use
Tube, bottle
6
Adhesive plaster
Plaster
III. ORGANIZATION OF
IMPLEMENTATION
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2. Foreign-invested enterprises
may not open their own drug retail establishments according to the National
Assemblys Resolution No. 76/2003/QH11 of November 29, 2006, ratifying the
Protocol on Vietnams accession to the World Trade Organization, and the Trade
Ministrys Decision No. 10/2007/QD-BTM of May 21, 2007, announcing the roadmap
for goods trading and related activities.
3. The Ministry of Health and
provincial/ municipal Health Services shall inspect and examine hospital
pharmacies according to law.
4. In the course of
implementation, any arising problem should be reported in writing to the
Ministry of Health (the Drug Administration of Vietnam) for study and
settlement.