Based on practice and management requirements, the Ministry of Health reported to the Government, proposing to include this content in the Law amending a number of articles of the Law on Pharmacy and was approved by the National Assembly at the meeting on November 21, 2024.
Because medicine is an essential commodity that directly affects the health and even the lives of patients, the drafting agency was very cautious when proposing regulations on e-commerce in pharmaceutical business when promulgating this Law. To strictly control, management tools will be deployed synchronously, including pre-inspection and post-inspection.
The law stipulates that an establishment wishing to conduct e-commerce must be specifically assessed for its facilities, personnel, and documents and must be granted a Certificate of Eligibility for Pharmaceutical Business. That is, it must be an existing business establishment that has been licensed to operate in the traditional manner. Online sales are simply an activity carried out in parallel with traditional sales.
Therefore, whether doing business in the traditional way or online, the establishment must still fully comply with general regulations.
In addition, the draft stipulates that, except for cases of isolation due to group A epidemics, pharmaceutical business establishments are only allowed to retail via e-commerce for non-prescription drugs that are not drugs subject to special control or drugs with retail restrictions; drugs and pharmaceutical ingredients are sold wholesale via e-commerce for drugs and pharmaceutical ingredients that are not in the group of drugs subject to special control; in special cases, when a group A epidemic (similar to the recent COVID-19) is announced, establishments are allowed to retail prescription drugs according to regulations of the Ministry of Health; It is strictly forbidden to trade drugs and pharmaceutical ingredients via e-commerce through means other than e-commerce trading floors, e-commerce sales applications, and e-commerce sales websites with online ordering functions.
It is the responsibility of pharmaceutical businesses to provide customers with information about drugs and advice on drug use.
The draft has provisions that establishments doing business in e-commerce are responsible for:
+ Post information about the facility's Certificate of Eligibility for Pharmaceutical Business, Drug Circulation Registration Certificate, and approved information about the drug;
+ Must organize online consultation and guidance on how to use drugs in accordance with legal regulations for drug buyers and organize the delivery of drugs to buyers in accordance with regulations.
It is expected that when the revised Law on Pharmacy is issued, the Circulars guiding good retail drug practices will be adjusted and amended accordingly and have specific requirements for the operations of drug businesses in the form of e-commerce, including the method of implementation, advice on drug use, the responsibility of the professional in charge of selling drugs in the electronic environment to suit the characteristics of this form of business (for example, the control and approval of drug dispensing by retail establishments; advice and recording of drug use advice before the drug is delivered to customers, etc.), regulations on receiving online orders but before making the sale, there must be online or phone contact to determine whether the drug is eligible for sale, advice on use before selling the drug to the buyer, etc.
The establishment must notify the competent authority before conducting business via e-commerce.
Along with regulations to strictly manage e-commerce activities, the Drug Administration of Vietnam is also reviewing and proposing additional acts and measures to sanction administrative violations related to e-commerce in pharmaceutical business. In the initial phase of implementing the Law, e-commerce activities will certainly be prioritized for inspection and supervision to ensure that regulations are properly and fully implemented, helping people use drugs safely and effectively.
The legalization of e-commerce activities in pharmaceutical business provides many opportunities for retailers or wholesalers because it not only provides an additional sales channel but also opens up new markets, promotes products, enhances brand recognition and expands business capabilities of enterprises, while at the same time, creating favorable conditions for people to access information and buy drugs more easily.
