Decision No. 24/2008/QD-BYT dated July 11, 2008 of the Ministry of Health promulgating the regulation on organization and operation of hospital pharmacies

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.

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.

3. A hospital pharmacys operational fund must not be taken from non-business funds (including aid sources and hospital fees).

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:

a/ To retail drugs permitted for circulation.

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:

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:

III. ORGANIZATION OF IMPLEMENTATION

1. All hospitals shall organize the implementation of this Regulation, Directive No. 01/2008/ CT-BYT of January 25,2008, and other relevant regulations.

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.