Decree No. 79/2006/ND-CP dated August 09, 2006 of the Government detailing the implementation of a number of articles of the Pharmacy Law
SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
Hanoi, August 09, 2006
DETAILING THE IMPLEMENTATION OF A NUMBER OF ARTICLES OF THE PHARMACY LAW
Pursuant to the December 25, 2001 Law on Organization of the Government;
Pursuant to the June 14, 2005 Pharmacy Law;
At the proposal of the Health Minister,
Article 1.- Scope of regulation and subjects of application
1. This Decree details the implementation of a number of articles of the Pharmacy Law regarding:
a/ State policies on pharmacy;
b/ State management of drug prices;
c/ Conditions for trade in drugs;
d/ Management of drugs on the lists of those subject to special control;
e/ Drug quality standards, state-run drug-testing establishments and settlement of complaints about conclusions on drug quality;
f/ Competence and responsibility for state management of pharmacy.
2. This Decree shall apply to domestic and foreign agencies, organizations and individuals operating in the field of pharmacy in Vietnam.
Article 2.- Interpretation of terms
In this Decree, the terms below shall be construed as follows:
1. Lawful pharmaceutical establishments are those operating in the field of pharmacy and established under the provisions of law, including:
a/ Drug dealing establishments;
b/ Pharmaceutical sections of medical examination and treatment establishments;
c/ Pharmaceutical workers' schools;
d/ Pharmaceutical research institutes, drug-testing institutes or centers;
e/ Pharmacy state management agencies;
f/ Representative offices of foreign traders operating in the field of pharmacy in Vietnam;
g/ Other pharmaceutical establishments defined by law.
2. Posting of drug prices means the publicization of drug sale prices by way of printing, sticking, showing sale prices on drug packages or outer drug packages or displaying them on boards, papers or other means placed, hung or stuck at places where drugs are sold or supplied as provided for in Article 11 of this Decree.
Article 3.- Types of drug-dealing organizations
1. Drug-producing establishments shall cover the following types of business organizations:
a/ Drug-producing enterprises;
b/ Cooperatives, individual households producing materia medica, eastern medicines and/or drugs from materia medica.
2. Drug-wholesaling establishments shall cover the following types of business organizations:
a/ Drug-wholesaling enterprises;
b/ Cooperatives, individual households wholesaling materia medica, eastern medicines and/or drugs from materia medica;
c/ Vaccine and biologicals-wholesaling agents.
3. Drug-retailing establishments shall cover the business organization types specified in Clause 1, Article 24 of the Pharmacy Law.
4. Drug-exporting, -importing enterprises.
5. Enterprises providing drug preservation services.
6. Enterprises providing drug test services.
STATE POLICIES ON PHARMACY
Article 4.- Pharmaceutical projects entitled to investment preferences
Pharmaceutical projects shall enjoy investment preferences in capital, land, tax and other preferences under the provisions of law, including:
1. Projects aiming to develop the pharmaceutical industry into a spearhead econo-technical branch:
a/ Projects specified in Clause 1, Article 3 of the Pharmacy Law;
b/ Investment projects on construction of establishments for bio-equivalence experiment, drug utility assessment; pharmaceutical establishments satisfying good practice standards on production, preservation, test, distribution of drugs, clinical test of drug, cultivation, gathering and processing of materia medica.
2. Projects aiming to develop sources of materia medica and production of drugs therefrom:
a/ Projects on cultivation of materia medica, exploitation of meteria medica from nature, conservation and development of pharmaceutical gens sources;
b/ Projects on research into, proving scientific grounds and compiling standards for testing eastern drug prescriptions; survey and statistics on kinds of materia medica for drug production; collection, inheritance, popularization and rational application of eastern drug prescriptions; search for, and exploitation of the use of, new materia medica, export of materia medica.
Article 5.- Forms of support in drugs
1. Policy beneficiaries, ethnic minority areas, regions meeting with exceptional socio-economic difficulties, regions meeting with socio-economic difficulties shall enjoy drug prices not higher than the prices of drugs sold in mountainous communes, enjoy drug money exemption, reduction or supports as well as other regimes and policies on drug supports under the provisions of law.
2. The Health Ministry shall assume the prime responsibility for, and coordinate with the Ministry of Labor, War Invalids and Social Affairs, the Nationality Committee and the Finance Ministry, based on the requirements and policies on drug supports in each period, in studying the amendment and supplementation of drug support forms, regimes and policies provided for in Clause 1 of this Article, and submitting them to the Prime Minister for decision.
Article 6.- Planning on drug circulation, distribution and supply networks
Based on the tasks of socio-economic development of the country in each period, the Health Ministry shall formulate plannings and plans on development of drug circulation, distribution and supply nationwide, attaching special importance to deep-lying and remote regions, in order to ensure adequate drugs of good quality at reasonable prices, meeting people's drug demands and submit them to the Prime Minister for decision; organize the implementation of such plannings and plans after they are approved by the Prime Minister.
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