According to a decision by the Drug Administration, Wealphar Pharmaceutical Joint Stock Company (Head office address: Lot CN5, Thuy Van Industrial Park, Nong Trang Ward, Phu Tho Province) was fined 125 million VND.
The reason this company was fined is for committing an administrative violation: Failing to register changes and additions to the marketing authorization with the competent state agency and obtain prior approval before marketing the drugs and drug raw materials for minor changes requiring approval for 05 drugs: Valproate EC DWP 200mg (Registration No.: 893114113524), Metronidazole DWP 375mg (Registration No.: VD-35847-22), Oxcarbazepine DWP 150mg (Registration No.: 893114159723), Fefolic DWP 100 mg/350 mcg (Registration No.: 893110044924), Cyperdin 250mg (Registration No.: 893110159623).
Failure to notify the competent state authority of minor changes requiring prior notification before circulation for the following four drugs: Valproate EC DWP 200mg (Registration No.: 893114113524), Oxcarbazepine DWP 150mg (Registration No.: 893114159723), Felolic DWP 100 mg/350 mcg (Registration No.: 893110044924), and Cyperdin 250mg (Registration No.: 893110159623).
The above behavior violates the provisions of Point c, Clause 3, Article 56 of Government Decree No. 117/2020/ND-CP dated September 28, 2020, on administrative sanctions in the field of health, as amended by Point b, Clause 13, Article 2 of Government Decree No. 124/2021/ND-CP dated December 30, 2021, amending Decree 115/2018/ND-CP on administrative sanctions for food safety violations and Decree 117/2020/ND-CP on administrative sanctions in the field of health; and Clause 6, Article 56 of Government Decree No. 117/2020/ND-CP, as amended and supplemented by Point c, Clause 13, Article 2 of Government Decree No. 124/2021/ND-CP.
Point b, Clause 1, Article 56 of Government Decree No. 117/2020/ND-CP dated September 28, 2020, stipulating administrative sanctions in the field of health, is amended by Point a, Clause 13, Article 2 of Government Decree No. 124/2021/ND-CP dated December 30, 2021, amending Decree 115/2018/ND-CP stipulating administrative sanctions on food safety and Decree 117/2020/ND-CP stipulating administrative sanctions in the field of health; Clause 6, Article 56 of Government Decree No. 117/2020/ND-CP is amended and supplemented by Point c, Clause 13, Article 2 of Government Decree No. 124/2021/ND-CP.
According to the Drug Administration, the aggravating circumstances include the company's repeated violations (involving 5 drugs and 4 drugs).
Source: https://suckhoedoisong.vn/bo-y-te-phat-cong-ty-co-phan-duoc-pham-wealphar-169251231175015805.htm






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