SECTION 5: Technical information about the product quality.

5.1. Production process: The production process must be described fully, exactly and the factor that can pollute the product must be clearly indicated. 5.2. Criteria on the quality and testing method:The standard quality of the components, active ingredients and the exipient  (adjuvant) of the product must be suitable with the technical information promulgated in the […]

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SECTION 4: The label of veterinary products.

The proposed label must be contained in the dossier. For the imported veterinary products, the original label must be translated into the Vietnamese language. The information in the label must be suitable with the content of the Summary of product characteristics, including: Name of the veterinary products; The form of preparation; The component and the […]

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SECTION 3: Summary of Product Characteristics

This Summary of Product characteristics must include the important information about the products that the applicant wishes to register. The DAH will check the information in the dossier, if it meets the requirement and the meet the professional and management requirements, the content of the Summary of Product characteristics will be accepted and included in […]

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SECTION 1: The cover page and the index of the dossier.

A.     The cover page of the dossiers must include: (As indicated in sample 1) The purpose of registration of veterinary products; The name of the applicant; The names of veterinary products to be registered. B.     The index of the dossier (As indicated in sample 2) The dossier must be arranged in accordance with right order; […]

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Guidance for registration of veterinary product in Vietnam

I. The content of one dossier for registration of veterinary products The dossier for registration of veterinary products must be made in 03 sets, printed on the A4-sized papers, arranged in accordance with regulated order. One dossier for registration of veterinary products includes: Section 1: The cover page of the dossier (Sample 1); index of […]

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