THE MINISTRY OF HEALTH

Official Dispatch No. 5890/BYT-QLD dated September 19, 2013 of the Ministry of Health on guiding temporarily the extension of registration numbers and duration for submitting dossier of re-registration 
Respectfully to:
- The Health Departments of provinces and central affiliated cities;
- Companies related to registration and production of drugs circulated in Vietnam
On November 24, 2009, the Minister of Health promulgated the Circular No. 22/2009/TT-BYT, on registration of drugs (hereinafter abbreviated to the Circular No. 22/2009/TT-BYT). In the course of implementation, there are some difficulties, inadequacies which need to be amended to be consistent with the actual conditions. While waiting for amendments to Circular No. 22/2009/TT-BYT in accordance with procedures for promulgating legal documents and for timely removing the difficulties for enterprises in this present time, satisfying demand of production and business of companies related to registration and production of drugs circulated in Vietnam (hereinafter abbreviated to units), specially, enterprises with drugs already won bid for provision to medical examination and treatment establishments, as well as contributing in the effective implementation of Scheme on “ Vietnamese prioritizes the use of drugs made in Vietnam”, the Ministry of Health notifies guidelines on temporarily solving for effect extension of registration numbers and duration for submitting dossiers of re-registration as follows:
I. On effect extension of registration numbers:
1. The Ministry of Health shall consider permitting the effect extension of registration numbers for drugs of which the registration numbers are expired if they satisfy the following conditions:
a) Dossiers of re-registration have been submitted at the Ministry of Health (the Drug Administration of Vietnam) before the expired day of the old registration numbers but not yet been re-granted the registration numbers;
b) Having notices of winning bid of medical examination and treatment establishments before the expired day of registration numbers, but not yet re-granted new registration numbers;