GENERAL, ECTD & HUMAN MEDICINES TEMPLATES

Document NumberTitleCategoriesDate updatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
Notification Template 1 for Nitrosamine Risk Evaluation

2021 Dec

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Notification Template 2 for Nitrosamine Confirmatory Testing

2021 Dec

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Outcome of Risk for Nitrosamine Investigation

2021 Dec

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SAHPRA Variation Validation Template for eCTD

2020 Feb

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SAHPRA Variation Validation Template for eSubmission

2020 Feb

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6.16New Registration Validation Template for eCTD

2019 Jul

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6.30New Registration Validation Template for eSubmission

2019 Jul

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6.31Summary of Critical Regulatory Elements (SCoRE)

2020 Nov

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6.32Bioequivalence Trial Information Form (BTIF)

2020 Nov

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6.33Abridged review template

2019 Aug

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6.34Verified review template

2019 Aug

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6.38Additional Strength Biowaiver Application Form

2020 Nov

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6.39Biopharmaceutics Classification System (BCS) Based Biowaiver Application Form

2020 Nov

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