| Medicines Online Directory Toolkit | Guide, Guideline, Presentations, Toolkit | 03/10/2023 | 1 | Corporate, General ECTD & human medicines | www | Download | guide guideline presentations toolkit | corporate general-ectd-human-medicines-guidelines |
| 2.24 | Guidance For The Submission Of The South African CTD-eCTD – General & Module | Guideline | 15/05/2019 | 6 | General ECTD & human medicines | | Download | guideline | general-ectd-human-medicines-guidelines |
| SAHPGL-PEM-04 | International Metric System (SI) | Guideline | 23/03/2023 | 4 | General ECTD & human medicines | pdf | Download | guideline | general-ectd-human-medicines-guidelines |
| SAHPGL-CEM-PRE-01 | Guideline on Co-packaging of Medicines | Guideline | 15/02/2023 | 1 | CEM Pre-reg, Clinical Evaluations Management, General ECTD & human medicines | pdf | Download | guideline | cem-pre-reg clinical-evaluations-management general-ectd-human-medicines-guidelines |
| SAHPGL-CEM-PRE-02 | Guideline for Fixed Dose Combination Products (FDC Products) for HIVAIDS, Tuberculosis and Malaria | Guideline | 08/02/2023 | 2 | CEM Pre-reg, Clinical Evaluations Management, General ECTD & human medicines | pdf | Download | guideline | cem-pre-reg clinical-evaluations-management general-ectd-human-medicines-guidelines |
| 2.21 | South African Specification for eCTD Regional Module1 | Guideline | 30/05/2019 | 3 | General ECTD & human medicines | | Download | guideline | general-ectd-human-medicines-guidelines |
| SAHPGL-HPA-04 | Renewal of Human and Veterinary Medicines Requirements and Process | Guideline | 11/07/2023 | 3 | General ECTD & human medicines, HPA, Veterinary medicines | pdf | Download | guideline | general-ectd-human-medicines-guidelines hpa veterinary-medicines |
| 2.40 | Multiple submissions of the same application for registration with different proprietary names | Guideline | 23/05/2019 | 4 | General ECTD & human medicines | | Download | guideline | general-ectd-human-medicines-guidelines |
| 5.08 | Reliance Guideline | Guideline | 16/03/2022 | 3 | General ECTD & human medicines | | Download | guideline | general-ectd-human-medicines-guidelines |
| SAHPGL-INSP-02 | Guideline for Good Manufacturing Practice | Guideline | 18/09/2022 | 8 | General ECTD & human medicines, Inspectorate and good manufacturing practices, Licencing | pdf | Download | guideline | general-ectd-human-medicines-guidelines inspectorate-and-good-manufacturing-practices licencing |
| SAHPGL-PEM-01 | Availability of medicines for use in a Public Health Emergency (PHE) | Guideline | 21/08/2023 | 3 | Emergency use, General ECTD & human medicines, Section 21, Unregistered products | pdf | Download | guideline | emergency-use general-ectd-human-medicines-guidelines section-21 unregistered-products |
| SAHPGL-PEM-03 | Guideline for the API Master File (APIMF) Procedure | Guideline | 23/11/2022 | 3 | General ECTD & human medicines, PEM Pre-Reg, Pharmaceutical Evaluation Management | pdf | Download | guideline | general-ectd-human-medicines-guidelines pem-pre-reg pharmaceutical-evaluation-management |
| 2.58 | Submission in eSubmission format | Guideline | 18/07/2019 | 1 | General ECTD & human medicines | | Download | guideline | general-ectd-human-medicines-guidelines |
| 2.23 | Guideline for submission in eCTD format | Guideline | 18/07/2019 | 3 | General ECTD & human medicines | | Download | guideline | general-ectd-human-medicines-guidelines |
| SAHGPL-HPA-03 | eCTD Validation Criteria | Guideline | 16/11/2022 | 4 | General ECTD & human medicines, HPA | pdf | Download | guideline | general-ectd-human-medicines-guidelines hpa |
| SAHPGL-CEM-02 | Guideline for Professional Information for Human Medicines (Categories A and D) | Guideline | 07/09/2022 | 5 | Clinical Evaluations Management, General ECTD & human medicines, Health Products Authorisation | pdf | Download | guideline | clinical-evaluations-management general-ectd-human-medicines-guidelines health-products-authorisation |
| SAHPGL-CEM-03 | Guideline for Patient Information Leaflet for Human Medicines (Categories A D) | Guideline | 12/10/2022 | 7 | Clinical Evaluations Management, General ECTD & human medicines, Health Products Authorisation | pdf | Download | guideline | clinical-evaluations-management general-ectd-human-medicines-guidelines health-products-authorisation |
| SAHPGL-CEM-01 | Clinical guideline | Guideline | 24/08/2022 | 3 | Clinical Evaluations Management, General ECTD & human medicines | pdf | Download | guideline | clinical-evaluations-management general-ectd-human-medicines-guidelines |
| SAHPGL-HPA-06 | Variations Addendum For Human And Veterinary Medicines | Guideline | 14/09/2022 | 6 | General ECTD & human medicines, HPA, Veterinary medicines | pdf | Download | guideline | general-ectd-human-medicines-guidelines hpa veterinary-medicines |
| SAHPGL-PEM-02 | Quality and Bioequivalence guideline | Guideline | 23/05/2023 | 8 | General ECTD & human medicines | pdf | Download | guideline | general-ectd-human-medicines-guidelines |
| SAHPGL-HPA-07 | General information guideline | Guideline | 17/04/2023 | 11 | General ECTD & human medicines, HPA | pdf | Download | guideline | general-ectd-human-medicines-guidelines hpa |
| Industry Communication on Interim Measures Pending Update of Variation Addendum | Communication to industry, Guideline | 10/09/2020 | 1 | General ECTD & human medicines | pdf | Download | communication-to-industry guideline | general-ectd-human-medicines-guidelines |
