Công văn 5890/BYT-QLD hướng dẫn tạm thời việc gia hạn số đăng ký và thời hạn nộp hồ sơ đăng ký lại do Bộ Y tế ban hành

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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