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KPMG
Recent updates on legal legislation in November.
Tilleke & Gibbins
The last days of October brought some excitement for one of the leading pharmaceutical companies in the world, Novartis, when its patent litigation case in Vietnam against a local generic...
Tilleke & Gibbins
On June 30, 2023, the Ministry of Health of Vietnam issued Circular No. 14/2023/TT-BYT stipulating the process and procedure for building bidding package prices...
Tilleke & Gibbins
On March 3, 2023, the government of Vietnam issued Decree No. 07/2023/ND-CP (Decree 07) amending Decree 98/2021/ND-CP on medical device management (Decree 98) to resolve many urgent...
Tilleke & Gibbins
According to the Ministry of Health of Vietnam, many healthcare facilities in the country are facing a shortage of drugs, medical devices, and materials/chemicals.
Tilleke & Gibbins
On September 5, 2022, the Ministry of Health of Vietnam issued Circular No. 07/2022/TT-BYT on drugs requiring bioequivalence (BE) studies and requirements for dossiers reporting BE data when registering drugs in Vietnam (Circular 07).
Tilleke & Gibbins
On September 5, 2022, Vietnam's Ministry of Health (MOH) issued Circular No. 08/2022/TT-BYT on the registration of drugs and drug materials (Circular 08).
Russin & Vecchi
Vietnam's response to COVID-19 is a perfect example of how a country with modest financial means can successfully address a grave health challenge. At the end of Vietnam's first pandemic...
Tilleke & Gibbins
On July 13, 2022, the Vietnamese government issued Decree No. 46/2022/ND-CP amending and supplementing some articles of Decree No. 13/2020/ND-CP providing...
Tilleke & Gibbins
In late 2021, the government of Vietnam issued Decree 98 on the management of medical devices (Decree No. 98/2021/ND-CP dated November 8, 2021), which came into force on January 1, 2022.
Russin & Vecchi
Am hiểu luật và các quy định của Việt Nam liên quan đến thực phẩm có thể là một thách thức. Chính phủ dựa vào các luật chung để quy định chất lượng của hàng hóa, bao gồm thực phẩm.
Russin & Vecchi
Understanding Vietnamese laws and regulations concerning food can be a challenge. The government relies on general laws to regulate the quality of goods, including food.
Tilleke & Gibbins
On November 8, 2021, the Vietnamese government issued Decree No. 98/2021/ND-CP on the Management of Medical Devices ("Decree 98").
Tilleke & Gibbins
The Ministry of Health of Vietnam recently issued Circular No. 10/2021/TT-BYT dated June 30, 2021, stipulating the list of substances prohibited from use in the production and trading of health supplements ("Circular 10").
Duane Morris LLP
There is no denying that Vietnam truly is an attractive investment destination in South East Asia. It has great potential to develop a qualitative, self-sustaining life science sector.
Tilleke & Gibbins
Since 2016, the government of Vietnam has issued a number of legal documents on medical device management, including Decree No. 36/2016/ND-CP dated May 15, 2016; Decree No. 169/ND-CP dated December 31, 2018; and ...
Tilleke & Gibbins
The main administrative penalties under Decree 117 are reprimands and fines.
Duane Morris LLP
-Investment sector reduction: Article 04.01 of the new law sets out 05 investment sectors. Compared to Article 04.01 of Decree No. 63/2018/ND-CP...
Duane Morris LLP
Laut einer neu verabschiedeten Regelung in Jakarta, benötigt jedes nicht in Indonesien hergestellte Medikament eine zwingende Lizenz. Während für wirtschaftliche ...
Rouse
Nick Redfearn discusses Pharma-related counterfeiting in SEA in the Law, Lore & Practice, PTMG December 2022 edition...
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