REGISTRATION OF IMPORTED PHARMACEUTICAL PRODUCTS CONTAIN CEFTEZOL AND RABEPRAZOLE

Update: 20/09/2017

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On 15th September 2017, Drug Administration Department of Vietnam has enforced the Official Document number 14433/QLD-ĐK about registration of exported and imported pharmaceutical products contain Ceftezol and number 14434/QLD-ĐK for those contain Rabeprazol.
Content of the official announcements as following:
1. In case the imported finished pharmaceutical product contains Ceftezol and/or Rebeprazol is not registered yet, the importer shall submit clinical researches in accordance with purchase order to affirm its safety and effects.
2. In case the registration of imported finished pharmaceutical product contains Ceftezol and/or Rebeprazol is pending approval at Drug Administration Department, the importer shall submit clinical researches as an added document for registration files. The Drug Administration Department shall not approve any registration files unless the importer submits clinical researches in accordance with purchase order to affirm its safety and effects.
3. In case registration of imported finished pharmaceutical product contains Ceftezol and/or Rebeprazol is in valid period, still the importer shall submit clinical researches mentioned in Article 1 of this Official document. One year after the enforcement date of this Official document, if the importer fails to submit relevant clinical research, the Drug Administration Department shall annul the validity of the approved registration.
Source: Click here ⇒ Drug Administration Department