| GLF-RDN-INSP-01C | Template – Seal Letter | Templates | 19/11/2024 | 1 | Inspectorate, Radiation Control | docx | Download | templates | inspectorate radiation-control |
| GLF-RDN-INSP-01B | Template – Tech Unseal Letter | Templates | 19/11/2024 | 1 | Inspectorate, Radiation Control | docx | Download | templates | inspectorate radiation-control |
| GLF-RDN-INSP-01A | Template – Unseal Letter | Templates | 19/11/2024 | 1 | Inspectorate, Radiation Control | docx | Download | templates | inspectorate radiation-control |
| GLF-PEM-03A | Template of Amendment Schedule to APIMF Holder | Templates | 01/07/2024 | 1 | General ECTD & human medicines | docx | Download | templates | general-ectd-human-medicines-guidelines |
| GLF-HPA-07B | Letter of Permission from HCR | Templates | 22/05/2024 | 1 | General ECTD & human medicines, HPA | docx | Download | templates | general-ectd-human-medicines-guidelines hpa |
| GLF-HPA-07A | Declaration of Sameness for Clones and Replicas | Templates | 22/05/2024 | 1 | General ECTD & human medicines, HPA | docx | Download | templates | general-ectd-human-medicines-guidelines hpa |
| GLF-PEM-02K | CEP Letter of Access Template | Templates | 14/05/2024 | 1 | General ECTD & human medicines | docx | Download | templates | general-ectd-human-medicines-guidelines |
| GLF-RC-INSP-05B | Recall Letter to customers | Form, Templates | 30/01/2024 | 2 | Regulatory Compliance | docx | Download | form templates | regulatory-compliance |
| GLF-HPA-04A | ECTD Validation And Technical Screening For Renewals | Templates | 09/09/2024 | 4 | General ECTD & human medicines | docx | Download | templates | general-ectd-human-medicines-guidelines |
| 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 | 04/06/2024 | 2 | 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 | 01/07/2024 | 2 | 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 |
| OF-PEM-VET-01C | Veterinary Clinical Trial Application Template | Application forms, Form, Templates | 26/08/2024 | 3 | Clinical Trials, Veterinary medicines | docx | Download | application-forms form 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 |
| 6.18 | Validation template CM | Templates | 24/06/2020 | 2 | Complementary Medicines | | Download | templates | complementary-medicines |
| 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 |
