| Document Number | Title | Categories | Date Updated | Version | Units | File Type | Link | doc_categories_hfilter | doc_tags_hfilter |
|---|---|---|---|---|---|---|---|---|---|
| GLF-PEM-02L | Sameness Declaration Form for Reliance-based Models | Form | 20/08/2024 | 1 | General ECTD & human medicines, HPA, PEM | docx | Download | form | general-ectd-human-medicines-guidelines hpa pem |
| GLF-HPA-06B | CTD Checklist | Form | 23/07/2024 | 1 | General ECTD & human medicines | docx | Download | form | general-ectd-human-medicines-guidelines |
| GLF-HPA-06A | Z-Code Request Form | Form | 23/07/2024 | 1 | General ECTD & human medicines | docx | Download | form | general-ectd-human-medicines-guidelines |
| GLF-PEM-02E | Letter of Access for Reliance | Form | 26/05/2023 | 1 | General ECTD & human medicines, PEM Pre-Reg, Pharmaceutical Evaluation Management | docx | Download | form | general-ectd-human-medicines-guidelines pem-pre-reg pharmaceutical-evaluation-management |
| GLF-PEM-02A | Submission Form Template | Form | 01/07/2024 | 2 | General ECTD & human medicines | docx | Download | form | general-ectd-human-medicines-guidelines |
| GLF-BAU-HPA-07A | Medicines Application Form Module 1.2.1 | Application forms, Form | 18/05/2023 | 7 | General ECTD & human medicines | docx | Download | application-forms form | general-ectd-human-medicines-guidelines |
| OF-PEM-PRE-01I | Biopharmaceutics Classification System (BCS) Based Biowaiver Application Form | Form | 12/08/2022 | 4 | General ECTD & human medicines, PEM Pre-Reg, Pharmaceutical Evaluation Management | docx | Download | form | general-ectd-human-medicines-guidelines pem-pre-reg pharmaceutical-evaluation-management |
| OF-PEM-PRE-01H | Additional Strength Biowaiver Application Form | Form | 18/08/2022 | 4 | General ECTD & human medicines, PEM Pre-Reg, Pharmaceutical Evaluation Management | docx | Download | form | general-ectd-human-medicines-guidelines pem-pre-reg pharmaceutical-evaluation-management |
| OF-PEM-PRE-01J | Bioequivalence Trial Information Form (BTIF) | Form | 19/08/2022 | 4 | General ECTD & human medicines, PEM Pre-Reg, Pharmaceutical Evaluation Management | docx | Download | form | general-ectd-human-medicines-guidelines pem-pre-reg pharmaceutical-evaluation-management |
| OF-HPA-06A | SAHPRA Pre-Submission Meeting Request Form | Form | 05/08/2021 | 2 | General ECTD & human medicines, HPA | docx | Download | form | general-ectd-human-medicines-guidelines hpa |