The decision stated that the recovery was implemented based on the request of the Head of the Drug Registration Division - the Drug Administration Department. Specifically, 3 drugs were revoked the circulation registration certificate, which was requested by the drug registration facility that voluntarily stopped circulating these products in the Vietnamese market. The recovered drugs include:
1. Tadalafil 20mg. Registration number: 893110457024 (old registration number: VD-31364-18). Registration and production facility: Meyer-BPC Joint Venture Company. Address: 6A3, National Highway 60, Phu Tan Ward, Ben Tre City, Ben Tre Province
2. Odistad 120. Registration number: 893100515124 (old registration number: VD-21535-14). Registration facility: contest contested Photopharm Company Limited. Registration address: K63/1 Nguyen Thi Soc, My Hoa 2 Hamlet, Xuan Thoi Dong Commune, Hoc Mon District, Ho Chi Minh City. Production facility: Stellapharm - Branch 1, No. 40 Thu Do Avenue, VSIP Industrial Park, An Phu Ward, Thuan An City, Binh Duong Province
3. Vacobufen 400. Registration and production facility: Vacopharm Pharmaceutical Joint Stock Company. Registration address: 59 Nguyen Hue, Ward 1, Tan An City, Long An Province. Production address: Km 1954, National Highway 1A, Tan Khanh Ward, Tan An City, Long An Province
Accordingly, drugs that have been produced before the effective date are still allowed to continue circulation until the expiration date. However, drug registration and manufacturing facilities must still take full responsibility for monitoring the quality, ensuring the safety and effectiveness of the drug throughout the remaining circulation process.
At the same time, Directors of the Departments of Health of provinces and centrally run cities, pharmaceutical businesses, as well as directors of establishments registering and producing the above drugs must seriously implement the contents of the decision.
