GENERAL, ECTD & HUMAN MEDICINES TEMPLATES

Document NumberTitleCategoriesDate updatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
Notification Template 1 for Nitrosamine Risk Evaluation

2021 Dec

1Downloadtemplatesgeneral-ectd-human-medicines-guidelines
Notification Template 2 for Nitrosamine Confirmatory Testing

2021 Dec

1Downloadtemplatesgeneral-ectd-human-medicines-guidelines
Outcome of Risk for Nitrosamine Investigation

2021 Dec

1Downloadtemplatesgeneral-ectd-human-medicines-guidelines
SAHPRA Variation Validation Template for eCTD

2020 Feb

1Downloadtemplatesgeneral-ectd-human-medicines-guidelines
SAHPRA Variation Validation Template for eSubmission

2020 Feb

1Downloadtemplatesgeneral-ectd-human-medicines-guidelines
6.16New Registration Validation Template for eCTD

2019 Jul

3Downloadtemplatesgeneral-ectd-human-medicines-guidelines
6.30New Registration Validation Template for eSubmission

2019 Jul

1Downloadtemplatesgeneral-ectd-human-medicines-guidelines
6.31Summary of Critical Regulatory Elements (SCoRE)

2020 Nov

3Downloadtemplatesgeneral-ectd-human-medicines-guidelines
OF-PEM-PRE-01JBioequivalence Trial Information Form (BTIF),

2022 Aug

4, docxDownloadform templatesgeneral-ectd-human-medicines-guidelines pharmaceutical-evaluation-management
6.33Abridged review template

2019 Aug

2Downloadtemplatesgeneral-ectd-human-medicines-guidelines
6.34Verified review template

2019 Aug

2Downloadtemplatesgeneral-ectd-human-medicines-guidelines
OF-PEM-PRE-01HAdditional Strength Biowaiver Application Form,

2022 Aug

4, docxDownloadform templatesgeneral-ectd-human-medicines-guidelines pharmaceutical-evaluation-management
OF-PEM-PRE-01IBiopharmaceutics Classification System (BCS) Based Biowaiver Application Form,

2022 Aug

4, docxDownloadform templatesgeneral-ectd-human-medicines-guidelines pharmaceutical-evaluation-management