This Decree stipulates conditions for issuance of certificate of eligibility for drug business, including manufacture, wholesale, retail, export & import, preservation service, testing service and clinical trial service. It covers also herbal ingredient, narcotic drugs, psychotropic drugs, drug precursors and radiopharmaceuticals.

Under this Decree, a drug-trading establishment must satisfy good practice requirements established by WHO corresponding to each form and scope of business below:

a) Good manufacturing practice (GMP) requirements shall be satisfied by drug manufacturers;

b) Good distribution practice (GDP) requirements shall be satisfied by drug wholesalers;

c) Good pharmacy practice (GPP) requirements shall be satisfied by drug retailers;

d) Good storage practice (GSP) requirements shall be satisfied by drug preservation service providers and drug importers;

dd) Good laboratory practice (GLP) requirements shall be satisfied by drug-testing service providers;

e) Good clinical practice (GCP) requirements shall be satisfied by clinical trial service providers;

g) Good storage practice (GSP) requirements applied to herbal ingredients shall be satisfied by herbal ingredient preservation service providers and herbal ingredient importers;

h) Good distribution practice (GDP) requirements applied to herbal ingredients shall be satisfied by herbal ingredient wholesalers.

This Decree becomes effective since July 1, 2016. Articles 20 through 27 of Decree No. 79/2006/ND-CP dated August 9, 2006 are abolished since the effective date of this Decree.