REGULATIONS ON DRUG PROCESSING ACTIVITIES
On August 13, 2013, the Ministry of Health issues the Circular No. 23/2013/TT-BYT guiding the drug processing activities.
At this Circular, the Ministry of Health requires that The Vietnamese legal drug business establishments, foreign drug business and manufacturing establishments that have “Operation Permit of foreign enterprises on drugs and drug materials in Vietnam” and drugs whose registration number has been issued by the Vietnam Ministry of Health and is still valid or that are the patent owners or research subjects accepted as prescribed by Vietnam law or product research materials at the processing establishment for drugs without circulation registration number in Vietnam ordered for manufacturing and processing.
The processing Party may consist of a lot of manufacturers and each manufacturer is involved in one or a lot of stages of manufacturing and must satisfy conditions as follows: for pharmaceutical chemical drugs, herbal drugs (except for oriental drug), vaccines, sera containing antibodies, biomedical products: manufacturing establishment in
Vietnam with certificates of edibility for drug business and certificate of standard satisfaction of "Good manufacturing practice" (GMP) with the dosage form of suitable for drugs intended for processing; and for in vitro diagnostic biological products: manufacturing establishment in Vietnam with certificate of eligibility for drug business and certificate of standard satisfaction of "Good manufacturing practice" (GMP) or TCVN ISO 13485 or other equivalent standards with the dosage form of suitable for drugs intended for processing.
Besides, the Circular also prescribes some processed and manufactured drugs For drugs with circulation registration number in Vietnam: Being manufactured and processed in one, a number or entire stage of the manufacturing process at one or a number of processing manufacturers; and for drugs without circulation registration number in Vietnam: Being manufactured and processed in the entire stage of the manufacturing process and placed only at one processing manufacturer.
This Circular takes effect on October 01, 2013.
