Penalties for drug regulation violations against 7 pharmaceutical companies

Mr. Nguyen Viet Hung - Deputy Director of the Department of Drug Administration (Ministry of Health) said that the Department's leaders have just signed an Official Dispatch announcing the temporary suspension of receiving and reviewing dossiers on drug registration, drug import... for 7 domestic and foreign pharmaceutical companies.

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These are: Yash Pharma Laboratories Pvt. Ltd India; M/s Bio-Labs (Pvt) Ltd., Pakistan; Austin Pharma Specialties Co., HongKong; Healthecare Pvt Ltd, India; United Pharmaceuticals Limited; Miracle Labs (P) Ltd. India; Biodeal Pharmaceutical Pvt Ltd., India.

Accordingly, the Drug Administration of Vietnam temporarily stops receiving initial registration applications, re-registration applications, and temporarily stops issuing drug circulation registration numbers for submitted applications produced and registered by the seven above-mentioned companies.

The Drug Administration of Vietnam also temporarily stops receiving and reviewing drug import dossiers for drugs manufactured and supplied to Vietnam by these companies; Temporarily stops receiving and reviewing dossiers for declaration of original brand-name drugs and bioequivalent drugs manufactured and declared by the above companies.

The period of temporary suspension of receiving and reviewing company applications is 12 months from January 9, 2015.

For the submitted dossiers (if any) of the seven Companies before January 9, 2015, the Department of Drug Administration is still conducting appraisal but has not considered granting registration numbers within the 12-month period mentioned above.

According to Vietnam+