30/05/2020
The legal framework for regulatory reforms in Vietnamese Pharma. Prepared in association with Tilleke & Gibbins, a leading law firm in Vietnam, this is an extract from The Pharma Legal Handbook: Vietnam, available to purchase here for GBP 75. 1. Are there proposals for reform or significant change to the healthcare system? The MOH published a draft version of an amended Law on Medical Examination and Treatment dated 12 October 2019 to collect public opinions. Once adopted, the new…
All about patents & trademarks in Viatnamese Pharma. Prepared in association with Tilleke & Gibbins, a leading law firm in Vietnam, this is an extract from The Pharma Legal Handbook: Vietnam, available to purchase here for USD 99. 1. What are the basic requirements to obtain patent and trademark protection? PATENT To qualify for patent protection, an invention must meet the following basic conditions: Be globally novel; Involve an inventive step; and Have its subject matter capable of industrial…
The low-down on the situation regarding product liability in Vietnamese Pharma. Prepared in association with Tilleke & Gibbins, a leading law firm in Vietnam, this is an extract from The Pharma Legal Handbook: Vietnam, available to purchase here for GBP 75. 1. What types of liability are recognized in your jurisdiction? The following types of liability are recognized under Vietnamese laws: disciplinary liability, administrative liability, civil liability and criminal liability. 2. How do these types of liabilities apply…
Want to know more about traditional medicines and OTC products in Vietnamese Pharma? Read on! Prepared in association with Tilleke & Gibbins, a leading law firm in Vietnam, this is an extract from The Pharma Legal Handbook: Vietnam, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The Law on Pharmacy and its implementing regulations are equally applicable to modern drugs and traditional and herbal drugs.…
The key facts about marketing, manufacturing, packaging & labeling, advertising in Vietnamese Pharma. Prepared in association with Tilleke & Gibbins, a leading law firm in Vietnam, this is an extract from The Pharma Legal Handbook: Vietnam, available to purchase here for GBP 75. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? PHARMACEUTICAL PRODUCTS Under Vietnamese law, pharmaceutical products or drugs are defined to cover all modern…
A brief overview of the situation regarding preclinical and clinical trial requirements in Vietnamese Pharma. Prepared in association with Tilleke & Gibbins, a leading law firm in Vietnam, this is an extract from The Pharma Legal Handbook: Vietnam, available to purchase here for GBP 75. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? By law, clinical research documentation for the purpose of obtaining the MA must conform to the…
An intro to the legal situation for regulatory, pricing and reimbursement in Vietnamese Pharma. Prepared in association with Tilleke & Gibbins, a leading law firm in Vietnam, this is an extract from The Pharma Legal Handbook: Vietnam, available to purchase here for GBP 75. 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? In Vietnam, pharmaceutical products (including drugs and biologicals) and medical devices are under the overall management of the…
20/03/2019
The market for pharmaceuticals in Vietnam is developing rapidly, in step with the country’s growing and aging population, rising per capita income, and increasing awareness of foreign brand-name drugs, which many Vietnamese consumers consider to be more reliable than generics and local brands. Naturally, Vietnam has become an attractive investment destination for foreign pharmaceutical companies eager to target new customers. The government is doing its part to encourage this investment, as seen by its participation in international free trade…
The key facts about marketing, manufacturing, packaging & labeling, advertising…
All about patents & trademarks in Viatnamese Pharma. Prepared in…
The low-down on the situation regarding product liability in Vietnamese…
The market for pharmaceuticals in Vietnam is developing rapidly, in…
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