Continuing the program of the 32nd session, on the afternoon of April 16, the National Assembly Standing Committee gave opinions on the Law Project amending and supplementing a number of articles of the Pharmacy Law.

Reporting at the meeting, Minister of Health Dao Hong Lan said that compared to the current law, the draft Law amends and supplements 43 articles, of which: amend 40 articles, supplement 03 articles, abolish 04 articles. points and 02 clauses. 

One of the notable contents in the draft law is to amend and supplement a number of regulations on organization and rearrangement of the business and distribution system of drugs and medicinal ingredients; Authority to issue pharmacy practice certificates.

According to Minister Dao Hong Lan, the bill supplements a number of regulations related to the right to distribute drugs of FIE pharmaceutical businesses, adjusting the right to distribute drugs and medicinal ingredients of these enterprises to ensure compliance. with practice. At the same time, add a number of business types and business conditions for pharmacy chain business, medicine business by e-commerce method and the rights and responsibilities of the above business establishments; Supplementing regulations on granting Certificates of eligibility for pharmaceutical business to public service units that collect fees in pharmaceutical activities.

In addition, the draft law amends regulations on business conditions for drugs subject to special control according to the plan approved in Decision No. 1661/QD-TTg. 

On the other hand, supplement the authority of the Ministry of Public Security and the Ministry of National Defense to issue, re-issue, adjust the content, and revoke pharmacy practice certificates for people in charge of clinical pharmacy work of medical examination facilities. , medical treatment falls under management authority.

Examining this content, the Standing Committee of Social Affairs found that this addition is necessary to meet practical requirements, but proposed to clarify the connotation of “pharmacy chain business” and be more specific about the regulations. Determine conditions for establishment, operating methods, and management mechanisms to have a basis for consideration and ensure feasibility and consensus.

For trading in drugs and medicinal ingredients by e-commerce, it is necessary to have more specific regulations on the types of drugs to be traded, the forms of business to be carried out by e-commerce, and the subjects. Participate in buying and selling to create transparency in regulations and ensure safety for users. If regulations on drug retailing by e-commerce method are prescribed, it should only apply to non-prescription drugs. In addition, it is necessary to review regulations on e-commerce to ensure compliance with the Law on Electronic Transactions.

Speaking at the meeting, National Assembly Chairman Vuong Dinh Hue assessed that the preparation and development of the Law project has made great progress in thinking in pharmaceutical management; The bill was prepared meticulously and seriously; Much modified scale. At the same time, he said that although it was only a preliminary examination, the Social Committee’s opinion was very profound and comprehensive.

Regarding specific issues, paying attention to the bill supplementing regulations on new forms and methods of business, the Chairman of the National Assembly emphasized that medicine is a very special type of goods, so it is necessary to find a balance between create favorable conditions for producers and businesses while protecting people’s health. 

“Drugs are a very special item that directly affects people’s health, therefore selling drugs in general and selling drugs via e-commerce must be controlled very tightly, and specific impacts need to be assessed” – The Chairman of the National Assembly emphasized and requested the Drafting Committee and the Social Committee to coordinate to more specifically and strictly regulate this new business method.

Accordingly, it is recommended to consider carefully, on the basis of assessing the benefits, risks, and consequences for patients when buying drugs online; Assess the level of control of state management agencies; At the same time, research the experiences of countries around the world with this issue.

Referring to the draft law stipulating that pharmaceutical retail establishments are allowed to sell drugs on the list prescribed by the Ministry of Health and sold by e-commerce method in accordance with the scope of business in the certificate of eligibility. business, the Chairman of the National Assembly raised the issue: if a pharmacy is part of a pharmacy chain that shares a website, how do people determine where to sell? Who sold? In addition, it is necessary to clarify how businesses with drug retail chains for people will consider and assign responsibility when a specific incident occurs.

The Chairman of the National Assembly also suggested that it is necessary to clarify what freedom and equality in business mean between retail establishments and chains? “In reality today, in our country, most are retail stores, while there are very few chains. Therefore, it is necessary to evaluate the impact of the policy for drug retail chains on retail establishments more carefully, especially in coordination with VCCI and the Ministry of Planning and Investment to consider the issue of equality and non-discrimination. in business” – Chairman of the National Assembly emphasized.

Noting that the most concerning issue in chain business is legal issues, the Chairman of the National Assembly proposed a closer review of processes, procedures, and legal liability issues such as: Opening an additional retail outlet in the future. What procedures do pharmacy chains follow? Which facilities sell directly to buyers or are all pharmacies in the chain sold via e-commerce? If only a few establishments are sold, how is the pharmacy’s responsibility for quality and issues arising to customer rights resolved?

At the meeting, members of the National Assembly Standing Committee also discussed the State’s policies on pharmaceuticals and industrial development; reform administrative procedures, strengthen decentralization and decentralization of powers in pharmaceutical management activities; Drug price management…/.



Stellapharm J.V. Co., Ltd. is currently known as one of leading generics pharmaceutical companies and strong manufacturers in Vietnam.
Established in 2000, Stellapharm was built on the foundation of a manufacturing factory in Vietnam and formed a joint venture with a partner from Germany. We focus on both prescription drugs and non-prescription especially in cardiovascular diseases, anti-diabetics drugs, etc. Products of Stellapharm are now used by millions of patients in more than 50 countries worldwide.
The company is globally recognized for its quality through our facilities have been audited and approved by stringent authority like EMA, PMDA, Taiwan GMP, local WHO and others.

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