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GENERAL, ECTD & HUMAN MEDICINES TEMPLATES

Document NumberTitleCategoriesDate UpdatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
GLF-PEM-02DTemplate for Module 2.3_Quality Overall Summary (QOS)03/05/20231, docxDownloadtemplatesgeneral-ectd-human-medicines-guidelines pharmaceutical-evaluation-management
GLF-PEM-02CTemplate for Module 2.3_Quality Information Summary (QIS)03/05/20231, docxDownloadtemplatesgeneral-ectd-human-medicines-guidelines pharmaceutical-evaluation-management
OF-PEM-PRE-01QQuality And Bioequivalence Verified Review Template13/04/20231, , docxDownloadtemplatesgeneral-ectd-human-medicines-guidelines pem-pre-reg pharmaceutical-evaluation-management
GLF-PEM-02BTemplate of Standardised Content of Letter of Access14/10/20221docxDownloadtemplatesgeneral-ectd-human-medicines-guidelines
OF-PEM-PRE-01PQuality And Bioequivalence Abridged Review Template13/04/20231, , docxDownloadtemplatesgeneral-ectd-human-medicines-guidelines pem-pre-reg pharmaceutical-evaluation-management
6.31Summary of Critical Regulatory Elements (SCoRE)19/11/20203docxDownloadtemplatesgeneral-ectd-human-medicines-guidelines
6.30New Registration Validation Template for eSubmission17/07/20191Downloadtemplatesgeneral-ectd-human-medicines-guidelines
6.16New Registration Validation Template for eCTD17/07/20193Downloadtemplatesgeneral-ectd-human-medicines-guidelines
SAHPRA Variation Validation Template for eSubmission27/02/20201Downloadtemplatesgeneral-ectd-human-medicines-guidelines
GLF-HPA-03AValidation Template For ECTD Variation Applications16/05/20232docxDownloadtemplatesgeneral-ectd-human-medicines-guidelines
Outcome of Risk for Nitrosamine Investigation29/12/20211Downloadtemplatesgeneral-ectd-human-medicines-guidelines
Notification Template 2 for Nitrosamine Confirmatory Testing15/12/20211Downloadtemplatesgeneral-ectd-human-medicines-guidelines
Notification Template 1 for Nitrosamine Risk Evaluation31/12/20211Downloadtemplatesgeneral-ectd-human-medicines-guidelines