THE MINISTRY OF HEALTH
DRUG ADMINISTRATION OF VIETNAM

Official Dispatch No. 7616/QLD-CL dated May 21, 2013 of the Drug Administration of Vietnam preparing dossier to request for the announcement of drugs with documents proving bioequivalence
Respectfully to:
- Departments of Health of central-affiliated cities and provinces;
- Drug manufacturers and traders;
- The establishments having drugs registered and circulated in Vietnam.
Following the Decision No. 2962/QD-BYT dated 22/8/2012 of the Minister of Health, on promulgating temporary regulation on documents need supply in order to announce lists of original proprietary medicines, medicines used for treatment similar with original proprietary medicines, medicines with documents proving bioequivalence,
Pursuant to provisions in the Circular No. 08/2010/TT-BYT dated 26/4/2010 of the Ministry of Health, guiding report of bioavailability/bioequivalence study data when registering drugs, the Joint Circular No. 01/2012/TTLT-BYT-BTC dated 19/01/2012 of the Ministry of Health and the Ministry of Finance guiding bidding of drugs procurement in the medical facilities; the Circular No. 11/2012/TT-BYT dated  28/6/2012 of the Ministry of Health providing guidance on preparation of tender invitation documents for drug purchase in medical facilities,
Drug Administration of Vietnam specifies dossiers to request for the announcement of drugs with documents proving bioequivalence, including dossier to report on bioequivalence study data enclosed with dossier of drug registration as follows:
I. Dossier to request for the announcement of drugs with documents proving bioequivalence
Establishments requesting for the announcement of drugs with documents proving bioequivalence should supply dossier in Vietnamese or English as follows:
1. Written request for the announcement of drugs with documents proving bioequivalence: made according to Form in the Annex 3 of Decision No. 2962/QD-BYT dated 22/8/2012 (this content does not apply to parts of dossier to report on bioequivalence study data enclosed with dossier of drug registration). 
2. Dossier to prove the legality of establishments studying bioequivalence: Establishments requesting for the announcement must supply one of following valid legal papers (original already consular legalized or copy from the original already consular legalized and authenticated lawfully):
2.1. Permit or certificate of establishments participating in study for eligibility to conduct bioavailability/bioequivalence study that is issued by the Ministry of Health or the Drug Management Authority of host country. In case of failing to supply permits or certificates above, establishments may supply information and evidences on the establishments participating in study having their names in list of study establishments recognized by the Ministry of Health or the Drug Management Authority of their host countries.
2.2. GCP and GLP Certificates (in accordance with regulations of host countries) that are issued by competent agencies or the recognized organizations of quality certification to the bioavailability/bioequivalence study establishments