Ministry of Health revokes circulation registration certificates of 13 drugs

The Drug Administration of Vietnam ( Ministry of Health ) has just decided to revoke the drug circulation registration certificates in Vietnam for 13 types of drugs, due to the drug registration facilities voluntarily requesting to revoke the circulation registration certificates.

Illustration photo. (Source: Internet)

Accordingly, the drug circulation registration certificate in Vietnam was revoked for 13 types of drugs including:

Tetraspan 6% solution for infusion, intravenous infusion dosage form, registration number: VN-18497-14, is registered by B. Braun Medical Industries Sdn. Bhd. (Address: Bayan Lepas Free Industrial Zone, 11900 Bayan Lepas, Pulau Pinang, Malaysia). Spiolto Respimat, inhalation solution dosage form, registration number VN3-361-21, is registered by Boehringer Ingelheim International GmbH (Address: Binger Strasse 173, 55216 Ingelheim am Rhein, Germany). Tamiflu, hard capsule dosage form, registration number VN-18299-14, is registered by F.Hoffmann-La Roche Ltd. (Address: 124 Grenzacherstrasse, CH-4070 Basel, Switzerland).

MS Contin 10mg, extended-release tablet formulation, registration number VN-21318-18; MS Contin 30mg, extended-release tablet formulation, registration number VN-21319-18; Norspan 10mcg/h, transdermal patch formulation, registration number VN3-266-20; Norspan 20mcg/h, transdermal patch formulation, registration number VN3-267-20; Norspan 5mcg/h, transdermal patch formulation, registration number VN3-268-20, are all registered by Mundipharma Pharmaceuticals Pte. Ltd (Address: 12 Marina View, #22-01 Asia Square Tower 2, Singapore 018961, Singapore).

Vinorelbine “Ebewe”, dosage form is concentrated solution for infusion, registration number VN-20829-17; Calciumfolinate “Ebewe”, dosage form is infusion solution, registration number VN-23089-22; Calciumfolinate “Ebewe”, dosage form is infusion solution, registration number VN-23090-22; Gliclazide Sandoz 30mg, dosage form is modified-release tablet, registration number VN-23041-22; Amoxicillin 250mg, dosage form is dispersible tablet, registration number VN-22180-19, all registered by Novartis (Singapore) Pte Ltd (Address: 10 Collyer Quay, # 10-01, Ocean Financial Centre Singapore (049315), Singapore).

According to the decision of the Drug Administration, foreign drugs imported into Vietnam before June 21 are allowed to be circulated until the expiry date of the drug. Drug registration and production establishments must be responsible for monitoring and taking responsibility for the quality, safety and effectiveness of the drug during its circulation.

This Decision takes effect from the date of signing and promulgation (June 21, 2023).

Source