The official letter 5890/BYT-QLD On guiding temporarily the extension of registration numbers and duration for submitting dossier of re-registration
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THE MINISTRY
OF HEALTH
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SOCIALIST REPUBLIC OF VIET NAM
Independence – Freedom - Happiness
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No. 5890/BYT-QLD
On guiding temporarily the extension of
registration numbers and duration for submitting dossier of re-registration
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Hanoi,
September 19, 2013
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Respectfully to:
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- The Health Departments of provinces and central
affiliated cities;
- Companies related to registration and production of drugs circulated in
Vietnam
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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;
c) Having dossier of request for the effect
extension of registration numbers of units related to registration for
production and circulation of drugs as prescribed in Clause 2 section I of this
official dispatch.
2. Dossier of request for the effect extension of
registration numbers includes:
a) Official dispatch of request for the effect extension
of registration numbers in which clearly stating reason;
b) Originals or copies notarized lawfully of:
- Notice of winning bid within 06 months from the
day of issuing notice, for medical examination and treatment establishments
organizing bid every 06 months /time, or annual basis, from the day of issuing
notice for establishments organizing bid every year /time, with respect to
drugs requested for extension.
- Contract of provision of drugs for medical
examination and treatment establishments, with respect to drugs of request for
extension.
3. The extended time and effect:
a) The extended time of old registration number
does not exceed 06 months, from the day the Ministry of Health (the Drug
Administration of Vietnam) issue a permission of extension in writing. Drugs
permitted production or import in time of effect extension of registration
numbers must be complied with dossier of registration kept in the Drug
Administration of Vietnam, and permitted to circulate till the use expiry day
of drugs.
b) Consideration to extend effect of registration
number for drugs shall be applied until this content of the Circular No.
22/2009/TT-BYT is amended, supplemented or replaced.
II. On time for submitting dossier of
re-registration
Dossiers of re-registration are submitted within 12
months before the expired day of old numbers of registration for circulation.
If dossiers of re-registration meet full conditions for grant of new
registration numbers before the expired day of old registration numbers, the
Ministry of Health shall consider grant of new registration numbers after the
expired day of old registration numbers.
The Ministry of Health notifies the Health
Departments of provinces and central affiliated cities, and units for
implementation. In the course of implementation, any arising problems should be
reported timely to the Ministry of Health (the Drug Administration of Vietnam)
for consideration and settlement.
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UNDER
AUTHORIZATION OF THE MINISTER OF HEALTH
DIRECTOR OF THE DRUG ADMINISTRATION OF VIETNAM
Truong Quoc Cuong
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