| GLF-PEM-02D | Template for Module 2.3_Quality Overall Summary (QOS) | Templates | 03/05/2023 | 1 | General ECTD & human medicines, Pharmaceutical Evaluation Management | docx | Download | templates | general-ectd-human-medicines-guidelines pharmaceutical-evaluation-management |
| GLF-PEM-02C | Template for Module 2.3_Quality Information Summary (QIS) | Templates | 03/05/2023 | 1 | General ECTD & human medicines, Pharmaceutical Evaluation Management | docx | Download | templates | general-ectd-human-medicines-guidelines pharmaceutical-evaluation-management |
| OF-PEM-PRE-01Q | Quality And Bioequivalence Verified Review Template | Templates | 13/04/2023 | 1 | General ECTD & human medicines, PEM Pre-Reg, Pharmaceutical Evaluation Management | docx | Download | templates | general-ectd-human-medicines-guidelines pem-pre-reg pharmaceutical-evaluation-management |
| GLF-PEM-02B | Template of Standardised Content of Letter of Access | Templates | 14/10/2022 | 1 | General ECTD & human medicines | docx | Download | templates | general-ectd-human-medicines-guidelines |
| GLF-PEM-VET-04A | Residue Overall Summary (ROS) | Templates | 15/09/2022 | 1 | Veterinary medicines | docx | Download | templates | veterinary-medicines |
| Veterinary Clinical Trial Application Template | Templates | 18/12/2019 | 2 | Clinical Trials, Veterinary medicines | | Download | templates | clinical-trials veterinary-medicines |
| Conformity of assessment body DoC template | Communication to industry, Templates | 30/03/2022 | 1 | Medical Devices | docx | Download | communication-to-industry templates | medical-devices |
| OF-PEM-PRE-01P | Quality And Bioequivalence Abridged Review Template | Templates | 13/04/2023 | 1 | General ECTD & human medicines, PEM Pre-Reg, Pharmaceutical Evaluation Management | docx | Download | templates | general-ectd-human-medicines-guidelines pem-pre-reg pharmaceutical-evaluation-management |
| 6.31 | Summary of Critical Regulatory Elements (SCoRE) | Templates | 19/11/2020 | 3 | General ECTD & human medicines | docx | Download | templates | general-ectd-human-medicines-guidelines |
| 6.30 | New Registration Validation Template for eSubmission | Templates | 17/07/2019 | 1 | General ECTD & human medicines | | Download | templates | general-ectd-human-medicines-guidelines |
| 6.16 | New Registration Validation Template for eCTD | Templates | 17/07/2019 | 3 | General ECTD & human medicines | | Download | templates | general-ectd-human-medicines-guidelines |
| SAHPRA Variation Validation Template for eSubmission | Templates | 27/02/2020 | 1 | General ECTD & human medicines | | Download | templates | general-ectd-human-medicines-guidelines |
| GLF-HPA-03A | Validation Template For ECTD Variation Applications | Templates | 16/05/2023 | 2 | General ECTD & human medicines | docx | Download | templates | general-ectd-human-medicines-guidelines |
| Outcome of Risk for Nitrosamine Investigation | Templates | 29/12/2021 | 1 | General ECTD & human medicines | | Download | templates | general-ectd-human-medicines-guidelines |
| Notification Template 2 for Nitrosamine Confirmatory Testing | Templates | 15/12/2021 | 1 | General ECTD & human medicines | | Download | templates | general-ectd-human-medicines-guidelines |
| Notification Template 1 for Nitrosamine Risk Evaluation | Templates | 31/12/2021 | 1 | General ECTD & human medicines | | Download | templates | general-ectd-human-medicines-guidelines |
