Although Vietnam is still a developing country, Vietnamese people are improving the knowledge about protecting health, curing and maintaining beauty. Due to the direct impact of pharmacy to human health, pharmacy is highly regulated area. Our pharmaceutical lawyers in Vietnam constantly monitor changes in legal environment and keep our client update on changes that would impact their business.
As defined in Law No.34/2005/QH11 on pharmacy, the concept of pharmacy means drugs and drug-related activities in which drugs include substances or mixtures for purposes of prophylaxis, therapy or diagnosis of disease or modification of physiological functions of human bodies, and consist of finished drugs, raw materials for drug manufacture, vaccines and medical biological products other than functional foods. Therefore, pharmacy concept under Vietnamese law covers all types of drug, vaccine, functional foods as well. As stated in Article 8 of Law No.34/2005/QH11, pharmacy activities are governed specially by Vietnam Ministry of Health. Due to the impact on human’s health, the process to bring a type of dug into a market must contain a number of steps and be strictly managed by government authorities. On production, the manufacturer is encouraged to set-up production in Vietnam as such could enjoy incentives on capital, land and taxation. In opposite, pharmacy trading is conditional business that requires approval from provincial or municipal health service and academic requirement of drug-retail owner.
The drug registration and circulation also attract the attentions from investors because of increasing demand in foreign drugs from Vietnamese. Based on results of clinical trials of the effectiveness and safety of drug, technical documents and current Vietnam’s national policies on drugs, a new type of drug may be registered at Vietnam Ministry of Health to grant a drug registration numbers after six month of submission. To proceed the next step for circulation, the drug must satisfy the quality standards as registry, label with full information such as name, preparation form, composition, packing specifications, conditions on packaging and price declaration. In case of imported, the drug must ensure the price is not higher than those of drug imported into regional countries with the healthcare and commercial conditions similar to Vietnam. Investors may consider investing or researching new drug, new functional foods, and vaccine in Vietnam.
ANT Lawyers advise pharmaceutical regulations in Vietnam. For our clients, this translates into comprehensive service across the range of legal, regulatory and legislative issues that manufacturers, importers, distributors and advertisers are likely to encounter in the pharmaceutical industry. Our lawyers provide expert assistance in the drug industries. Our scope of legal services include counseling clients on Vietnamese regulatory compliance, counseling clients on regulatory compliance under the rules of the government authorities, review of advertising and product claims in traditional and online media, documentation and review of sales contracts, distribution contracts, supply contracts and licensing agreements, and representation in administrative hearings and civil litigation. ANT Lawyers, your lawyers in Vietnam.