The Ministry of Health has stopped accepting applications for drug registration certificates from a pharmaceutical company.

The notice was signed by Mr. Nguyen Thanh Lam, Deputy Director of the Department of Drug Administration ( Ministry of Health ), on July 30, stating that the reason is that this company produced 2 batches of drugs that violated level 2 quality. The time limit for stopping receiving applications is 12 months, starting from July 30, 2025. When the deadline expires, companies wishing to register drugs and pharmaceutical ingredients must submit applications according to regulations.

Previously, in March, the Drug Administration of Vietnam announced the recall of two batches of Femancia Hard Capsules (Elemental Iron (as Ferrous fumarate 305 mg) 100 mg; Folic Acid 350 mcg), with registration number VD-27929-17, registered by Me Di Sun Pharmaceutical Joint Stock Company ( Ho Chi Minh City).

2 batches include: Batch number 031222, production date 12/2/2022, expiry date 12/2/2025 and batch number 020223, production date 2/21/2023, expiry date 2/21/2026. These batches were found to not meet quality standards for quantitative indicators, solubility, violating level 2.

In mid-July, the pharmaceutical management agency under the Ministry of Health also announced the revocation of the drug registration certificate in Vietnam for Femancia - an iron supplement that prevents iron deficiency anemia. At that time, the Drug Administration of Vietnam said that Femanica would not be produced and circulated on the market from July 16. Me Di Sun Pharmaceutical Joint Stock Company must recall the above drug according to regulations.

The level of drug violations is divided into 3 levels, of which level 1 is the most serious. Level 2 drugs are drugs with evidence of not ensuring full treatment effectiveness or having a risk of being unsafe for users but not to the extent of causing serious harm to health or affecting the life of the user.

The Ministry of Health also stipulates 24 cases of level 2 drug violations, for example, drugs produced from raw materials that do not meet quality standards; drugs without evidence of quality inspection during the production process and before being released from the factory; drugs without a circulation registration certificate or not yet permitted for import; drugs with a content exceeding the 5% limit compared to the limit specified in the registration dossier.

Vietnamnet

Source: https://baohaiphongplus.vn/bo-y-te-ngung-nhan-ho-so-cap-giay-dang-ky-luu-hanh-thuoc-cua-mot-cong-ty-duoc-417673.html