Tiếng Việt
Foreign investors interested to investing in the healthcare sector, specifically in the pharmaceutical industry of manufacturing, importing and distributing products to the market, they will have concerns how is Vietnam’s commitments to opening the market. In this article, herein we discuss the rights to distribute pharmaceutical products of foreign-invested enterprises in Vietnam.
Law on Pharmacy 105/2016/QH13, defined Pharmaceuticals are drugs and medicinal ingredients. Drug means a preparation that contains active ingredients or herbal ingredients used for prevention, diagnosis, treatment, alleviation of diseases in humans, regulation of human physiological functions, including modern drugs, herbal drugs, traditional drugs, vaccines and biologicals. Medicinal ingredient means an ingredient incorporated into the drug which may be an active ingredient, herbal ingredient, excipient, or capsule shells used during the manufacture of drugs.
Vietnam has excluded of the commitments in distribution services for certain products, which including pharmaceuticals products and drugs (for the purposes of this schedule, “pharmaceuticals and drugs” do not include non-pharmaceutical nutritional supplements in tablet, capsule and powder form). Its means that foreign-invested enterprises will not be allowed to conduct Pharmaceuticals distribution services in the Vietnam market.
Clause 10 Article 91 of Decree 54/2017/ND-CP, prescribed: “The entities that are entitled to import but not entitled to distribute drugs and medicinal ingredients in Vietnam must do activities related to distribution of drugs and medicinal ingredients in Vietnam except for drugs and medicinal ingredients they manufacture in Vietnam, including:
- Selling drugs and medicinal ingredients, delivery drugs and medicinal ingredients to health facilities, retailers, individuals and organizations other than wholesalers of drugs and medicinal ingredients;
- Receiving orders or payments for drugs and medicinal ingredients from health facilities, retailers, individuals and organizations other than wholesalers of drugs and medicinal ingredients;
- Providing drug, medicinal ingredient transport or storage services;
- Impose prices for drugs or medicinal ingredients distributed by other pharmaceutical-trading establishment;
- Deciding the strategy or policy on selling drugs, medicinal ingredients distributed by other pharmaceutical trading establishment;
- Developing the plan to supply of drugs and medicinal ingredients of health facilities in Vietnam;
- Provide financial assistance for buyers of drugs, medicinal ingredients to control the distribution of imported drugs and medicinal ingredients;
- Other activities related to drug distribution defined by law.”
Consequently, foreign-invested enterprises in Vietnam can’t distribute drugs and medicinal ingredients imported by its own. As an example, Official Letter No. 1109/QLD-KD dated September 24, 2021, the Drug Administration of Vietnam provides information about a wholesaler has the right to import drugs and medicinal ingredients but is not allowed to have the right to distribute such products in Vietnam, Johnson & Johnson (Vietnam) Co., Ltd. has the right to import, while Vimedimex Binh Duong One Member Co., Ltd has the right to wholesale for such products imported by Johnson & Johnson.
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Note: This article is for informational purposes only and it is not a legal advice. The content of the article represents its own of TTVN Legal, it subject to change without prior notice.