Pharmaceutical company FitoPharma was fined 120 million VND

Accordingly, FitoPharma Pharmaceutical Company Limited (Headquarters address: 26Bis/1 Trung Quarter, Vinh Phu Ward, Thuan An City, Binh Duong Province) committed many administrative violations and was subject to various forms of sanctions. Specifically: For the act of not carrying out the procedure for registering changes and supplementing the circulation registration certificate with the competent state agency and obtaining approval before circulating drugs and pharmaceutical ingredients for major changes and minor changes that need approval for the drug Andrographis paniculata, registration number: VD-24528-16, the company was fined 80 million VND.

The above behavior violates the provisions of Point c, Clause 3, Article 56 of Decree 117/2020/ND-CP dated September 28, 2020, amended and supplemented by Point b, Clause 13, Article 2 of Decree 124/2021/ND-CP dated December 28, 2021.

Next, for the act of not performing the notification procedure to the competent state agency for minor changes in the case of requiring notification before circulation for 5 drugs: Kim tien thao - f (Registration number: VD-21493-14), Diep ha chau (Registration number: VD-23286-15), Hoat huyet duong nao (Registration number: VD-22645-15), Gung (Registration number: VD-23926-15), Andrographis paniculata (Registration number: VD-24528-16), the company was fined 40 million VND (due to aggravating circumstances of violations for 5 drugs. This is considered a repeated violation).

The decision also clearly states that if FitoPharma Pharmaceutical Company Limited fails to comply within the prescribed time limit, it will be subject to enforcement in accordance with the provisions of law.

According to VNA