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(ii) Detailed information: Detailed information should include: (a) complete study protoco...

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(ii) Detailed information: Detailed information should include: (a) complete study protoco...

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7.7 Animal studies: (i) Where studies in an animal model have been undertaken to provide e...

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7.7 Animal studies: (i) Where studies in an animal model have been undertaken to provide e...

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Design and development validation: Design and development validation shall be performed in...

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7.3.6 Design and development validation: Design and development validation shall be perfor...

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PART IV INFORMATION REQUIRED TO BE SUBMITTED WITH THE APPLICATION FORM FOR IMPORT OR MANU...

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Note: 1. All the test reports submitted as a part of the dossier should be signed and date...

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Note: 1. All reports submitted as a part of the dossier should be signed and dated by the ...

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