| THE MINISTRY OF PUBLIC HEALTH ------- | SOCIALIST REPUBLIC OF VIET NAM Independence - Freedom - Happiness ---------- |
| No: 02/2007/TT-BYT | Hanoi, January 24, 2007 |
CIRCULAR
GUIDING IN DETAIL THE IMPLEMENTATION OF A NUMBER OF ARTICLES ON DRUG-DEALING CONDITIONS PRESCRIBED BY THE PHARMACY LAW AND THE GOVERNMENT'S DECREE NO. 79/2006/ND-CP OF AUGUST 9, 2006, DETAILING THE IMPLEMENTATION OF A NUMBER OF ARTICLES OF THE PHARMACY LAW
Pursuant to Pharmacy Law No. 34/2005-QH11 of June 14, 2005;
Pursuant to the Government's Decree No. 49/2003/ND-CP of May 15, 2003, specifying the functions, tasks, powers and organizational apparatus of the Health Ministry;
Pursuant to the Government's Decree No. 79/2006/ND-CP of August 9, 2006, detailing the implementation of a number of articles of the Pharmacy Law;
The Health Ministry hereby guides in detail the implementation of a number of article on drug-dealing conditions prescribed by the Pharmacy Law and Decree No. 79/2006/ND-CP of August 9, 2006, detailing the implementation of a number of articles of the Pharmacy Law (hereinafter referred to as Decree No. 79/2006/ND-CP) as follows:
I. GENERAL PROVISIONS
1. Governing scope and subjects of application
a/ This Circular guides in detail the implementation of a number of provisions on drug-dealing conditions; geographical areas where drug-retailing establishments in the form of drugstores, drug agents, commune health stations' medicine chests may be opened; diplomas for galenic physicians or herbalists, certificates of traditional drug prescriptions and traditional medicine and pharmacy qualifications; the form of pharmaceutical practice certificate and the form of certificate of full satisfaction of drug dealing conditions.
b/ This Circular applies to Vietnamese organizations and individuals, overseas Vietnamese; foreign organizations and individuals conducting drug business in Vietnam.
2. Principles of guidance
a/ This Circular only details articles, clauses and points assigned by the Pharmacy Law and Decree No. 79/2006/ND-CP to the Health Ministry to guide the implementation.
b/ Drug-dealing organizations and individuals shall abide by the provisions of the Pharmacy Law, Decree No. 79/2006/ND-CP, this Circular and other relevant legal documents.
3. Interpretation of terms
Drug-dealing locations of enterprises mean locations where drugs are directly manufactured, wholesaled, retailed or preserved or where drug-testing services are provided, which are at the same places of, or places other than, their headquarters or branch offices, and must be granted certificates of full satisfaction of drug-dealing conditions under the provisions of the Pharmacy Law.
II. DRUG-DEALING CONDITIONS
1. Drug-dealing conditions
a/ Professional managers possess the pharmaceutical practice certificates provided for in Article 15 of Decree No. 79/2006/ND-CP.
b/ The material and technical foundations and personnel meet the schedule for implementation of good practice standards suitable to each form of drug dealing under the provisions of Articles 21, 22, 23, 24, 25 and 26 of Decree No. 79/2006/ND-CP.
c/ The rights and obligations, the scopes of operation of drug-dealing establishments are defined in Articles 15, 16, 18, 22, 23, 26, 27, 28, 30, 32, 33 and 34 of the Pharmacy Law.
2. Conditions on drug-wholesaling locations of enterprises
a/ The drug-dealing conditions for drug-wholesaling locations of enterprises are defined in Article 22 of Decree No. 79/2006/ND-CP.
b/ For drug-wholesaling locations which were opened before June 1, 2003, whose professional managers are pharmacists of intermediate level, the business establishments must work out plans on training and arrangement of professional personnel or reorganize their business system to arrange people who meet the conditions prescribed at Point a, Clause 3, Article 15 of Decree No. 79/2006/ND-CP as professional managers by December 31, 2010, at the latest.
3. Conditions on drug-retailing locations of enterprises
The drug-dealing conditions on drug-retailing locations of enterprises are defined in Article 23 of Decree No. 79/2006/ND-CP.
4. Drug-retailing establishments as prescribed in Clause 2, Article 24 of the Pharmacy Law
a/ Forms of drug retail in wholesaling establishments are defined at Items a, b and c, Clause 1, Article 24 of the Pharmacy Law.
b/ Forms of drug retail in medical examination and treatment establishments cover drugstores, drug counters, medicine chests of health stations or traditional medicine or pharmaceutical drug-selling establishments.
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