6.21 | Licence Application Medical Device Manufacture | Application forms, Form | 2016 Jul
| 1 | Medical Devices | xls | Download | application-forms form | medical-devices |
6.12 | Complementary Medicines Section 21 Application Form | Application forms | 2013 Jul
| 1 | Complementary Medicines, Section 21 | | Download | application-forms | complementary-medicines section-21 |
GLF-CEM-PV-S01 | Valproate Annual Risk Acknowledgement Form | Form | 2022 Aug
| 1 | pharmacovigilance | pdf | Download | form | pharmacovigilance |
OF-HPA-06A | SAHPRA Pre-Submission Meeting Request Form | Form | 2021 Aug
| 2 | General ECTD & human medicines | docx | Download | form | general-ectd-human-medicines-guidelines |
OF-PEM-PRE-01J | Bioequivalence Trial Information Form (BTIF) | Form, Templates | 2022 Aug
| 4 | General ECTD & human medicines, Pharmaceutical Evaluation Management | docx | Download | form templates | general-ectd-human-medicines-guidelines pharmaceutical-evaluation-management |
OF-PEM-PRE-01H | Additional Strength Biowaiver Application Form | Form, Templates | 2022 Aug
| 4 | General ECTD & human medicines, Pharmaceutical Evaluation Management | docx | Download | form templates | general-ectd-human-medicines-guidelines pharmaceutical-evaluation-management |
OF-PEM-PRE-01I | Biopharmaceutics Classification System (BCS) Based Biowaiver Application Form | Form, Templates | 2022 Aug
| 4 | General ECTD & human medicines, Pharmaceutical Evaluation Management | docx | Download | form templates | general-ectd-human-medicines-guidelines pharmaceutical-evaluation-management |
6.22 | Licence application to distribute (import/export) medical devices | Application forms, Form | 2016 Jul
| 1 | Medical Devices | xls | Download | application-forms form | medical-devices |
6.26 | Licence application to wholesale medical devices | Application forms, Form | 2016 Nov
| 1 | Medical Devices | pdf | Download | application-forms form | medical-devices |
GLF-LIC-05A | Form for Licence Application to Cultivate Manufacture or Import Cannabis for Medicinal Purposes | Application forms, Form | 2022 Aug
| 1 | Cannabis, Inspectorate and good manufacturing practices, Licencing, Regulatory Compliance | docx | Download | application-forms form | cannabis inspectorate-and-good-manufacturing-practices licencing regulatory-compliance |
GLF-LIC-01A | Form for Licence Application to Manufacture Import or Export Medicines Scheduled Substances including Contract Testing Laboratories | Application forms, Form | 2022 Aug
| 1 | Inspectorate and good manufacturing practices, Licencing | docx | Download | application-forms form | inspectorate-and-good-manufacturing-practices licencing |
GLF-LIC-02A | Licence Application to act as a Wholesaler of Medicines and Scheduled Substances | Application forms, Form | 2022 Aug
| 1 | Inspectorate and good manufacturing practices, Licencing | docx | Download | application-forms form | inspectorate-and-good-manufacturing-practices licencing |
GLF-LIC-04A | Form for Licence Application for a Wholesaler to Export Medicines | Application forms, Form | 2022 Aug
| 1 | Inspectorate and good manufacturing practices, Licencing | docx | Download | application-forms form | inspectorate-and-good-manufacturing-practices licencing |
| Application for possession/research or analytical purpose | Application forms, Form | 2020 Feb
| 1 | Regulatory Compliance | | Download | application-forms form | regulatory-compliance |
| Application for a Permit to Import Drugs and/or Psycotropic Substances in terms of the Medicines and Related Substances Act, 1965 (Act 101 Of 1965), the Single Convention on Narcotic Drugs, 1961, and the Convention on Psycotropic Substances, 1971; Regulation 20(4) And 20(7)(S) | Application forms, Form | 2020 Apr
| 1 | Regulatory Compliance | | Download | application-forms form | regulatory-compliance |
| Application for a Permit to Export Narcotic and/or Psychotropic Substances in terms of the Medicines and Related Substances Act, 1965 (Act 101 Of 1965), The Single Convention on Narcotic Drugs, 1961, and the Convention on Psychotropic Substances, 1971: Regulation 20(4) and 20(7)(A) | Application forms, Form | 2020 Apr
| 1 | Regulatory Compliance | | Download | application-forms form | regulatory-compliance |
GLF-CEM-CT-01E | Notification Studies: Phase IV | Application forms, Form | 2022 Sep
| 4 | Clinical Trials | docx | Download | application-forms form | clinical-trials |
GLF-CEM-CT-01A | Clinical Trial Application Form | Application forms, Form | 2022 Jun
| 7 | Clinical Trials | docx | Download | application-forms form | clinical-trials |
GLF-CEM-CT-01B | Clinical Trial Application Form – Guidance in conditions of a Public Health Emergency | Application forms, Form | 2022 Jun
| 2 | Clinical Trials, Emergency use | docx | Download | application-forms form | clinical-trials emergency-use |
GLF-CEM-CT-01F | 2-Weekly Abridged Public Health Emergency Interim Progress Report Form for Clinical Trials | Form, Report forms | 2022 Sep
| 2 | Clinical Trials | docx | Download | form report-forms | clinical-trials |
GLF-CEM-CT-01C (CTF2) | Application for a Protocol Amendment to an Approved Trial | Application forms, Form | 2022 Sep
| 4 | Clinical Trials | docx | Download | application-forms form | clinical-trials |
GLF-CEM-CT-01D (CTF3) | Application for Additional Investigator(s) or Change of Investigator(s)/Sites and Application for Additional Sites | Application forms, Form | 2022 Sep
| 4 | Clinical Trials | docx | Download | application-forms form | clinical-trials |
GLF-CEM-CT-06A | Six monthly progress report form | Form, Report forms | 2022 Jun
| 4 | Clinical Trials | docx | Download | form report-forms | clinical-trials |
6.36 | Investigators workload Form | Application forms, Form | 2020 Apr
| 3 | Clinical Trials | | Download | application-forms form | clinical-trials |
GLF-CEM-CT-01H | Safety Reporting during Clinical Trial Form | Application forms, Form | 2022 Oct
| 4 | Clinical Trials | docx | Download | application-forms form | clinical-trials |
GLF-PEM-BIO-01A | Application Form for Lot Release of Human Vaccine | Application forms, Form | 2022 Sep
| 2 | Biological Medicines Evaluation and Research | pdf | Download | application-forms form | biological-medicines-evaluation-and-research |
OF-GOV-01A | Request for access to record of held by SAHPRA (PAIA form) | Form | 2021 Apr
| 1 | Corporate | docx | Download | form | corporate |
GLF-CEM-PV-06A | Adverse Drug Reactions and Quality Problem Reporting Form | Form | 2022 Aug
| 1 | pharmacovigilance | pdf | Download | form | pharmacovigilance |
OF-PEM-VET-01D | Progress Report Form After Use Of An Unregistered Product | Form, Report forms | 2022 Aug
| 1 | Emergency use, Section 21, Unregistered products, Veterinary medicines | docx | Download | form report-forms | emergency-use section-21 unregistered-products veterinary-medicines |
OF-PEM-VET-01E | Application form for unregistered veterinary medicines (Section 21) | Application forms, Form | 2022 Aug
| 2 | Section 21, Unregistered products, Veterinary medicines | docx | Download | application-forms form | section-21 unregistered-products veterinary-medicines |
| Owner Consent Form | Application forms, Form | 2019 Jul
| 2 | Veterinary medicines | | Download | application-forms form | veterinary-medicines |
1.2.1 | Application For Registration Of A Medicine Module 1: Administrative Information Application Form | Application forms, Form | 2020 Feb
| 1 | General ECTD & human medicines | | Download | application-forms form | general-ectd-human-medicines-guidelines |
OF-PEM-VET-04B | Veterinary Medicines Biowaiver Application Form for Parenterals | Form | 2022 Sept
| 1 | Veterinary medicines | docx | Download | form | veterinary-medicines |
OF-PEM-VET-04A | Bioequivalence Trial Information for Veterinary Medicines | Form | 2022 Sept
| 1 | Veterinary medicines | docx | Download | form | veterinary-medicines |
GLF-PEM-02A | Submission Form | Form | 2022 Oct
| 1 | General ECTD & human medicines | docx | Download | form | general-ectd-human-medicines-guidelines |
GLF-RDN-RN-14A | Monthly Report – Sealed Sources | Form | 2022 Dec
| 1 | Radiation Control, Radionuclides | pdf | Download | form | radiation-control radionuclides |
GLF-RDN-RN-15A | Monthly Report – Unsealed Sources | Form | 2022 Dec
| 1 | Radiation Control, Radionuclides | pdf | Download | form | radiation-control radionuclides |
RN523 | App_Liquid RA waste | Form | 2021 Dec
| 1 | Radiation Control, Radionuclides | docx | Download | form | radiation-control radionuclides |
RN524 | App_Solid RA waste | Form | 2021 Dec
| 1 | Radiation Control, Radionuclides | docx | Download | form | radiation-control radionuclides |
RN525 | App_Discard sealed sources | Form | 2021 Dec
| 1 | Radiation Control, Radionuclides | docx | Download | form | radiation-control radionuclides |
RN525i | App_Discard sealed sources | Form | 2021 Dec
| 1 | Radiation Control, Radionuclides | docx | Download | form | radiation-control radionuclides |
RN526 | App_Dispose of (sell) radionuclides | Form | 2021 Dec
| 1 | Radiation Control, Radionuclides | docx | Download | form | radiation-control radionuclides |
RN527 | App_Change details | Form | 2021 Dec
| 1 | Radiation Control, Radionuclides | docx | Download | form | radiation-control radionuclides |
RN607 | Medical report | Form | 2021 Dec
| 1 | Radiation Control, Radionuclides | docx | Download | form | radiation-control radionuclides |
RN608 | Particulars of sealed radioactive sources | Form | 2021 Dec
| 1 | Radiation Control, Radionuclides | docx | Download | form | radiation-control radionuclides |
RN621 | Application to release equipment from storage at NLM (NECSA) | Form | 2021 Dec
| 1 | Radiation Control, Radionuclides | docx | Download | form | radiation-control radionuclides |
RN778 | App_Register industrial radiographer | Form | 2021 Dec
| 1 | Radiation Control, Radionuclides | docx | Download | form | radiation-control radionuclides |
RN780 | Log for sealed gamma radiography sources | Form | 2021 Dec
| 1 | Radiation Control, Radionuclides | docx | Download | form | radiation-control radionuclides |
GLF-RDN-RN-16A | Import application | Form | 2022 Dec
| 1 | Radiation Control, Radionuclides | pdf | Download | form | radiation-control radionuclides |
RN781a | Confirmation of import | Form | 2021 Dec
| 1 | Radiation Control, Radionuclides | docx | Download | form | radiation-control radionuclides |
GLF-RDN-RN-17A | Export application | Form | 2022 Dec
| 1 | Radiation Control, Radionuclides | pdf | Download | form | radiation-control radionuclides |
RN782a | Confirmation of export | Form | 2021 Dec
| 1 | Radiation Control, Radionuclides | docx | Download | form | radiation-control radionuclides |
RN785 | App_Change of RPO | Form | 2021 Dec
| 1 | Radiation Control, Radionuclides | docx | Download | form | radiation-control radionuclides |
RN786 | App_Change of physicists | Form | 2021 Dec
| 1 | Radiation Control, Radionuclides | docx | Download | form | radiation-control radionuclides |
RN786A | App_RPA Radiation Protection Adviser | Form | 2021 Dec
| 1 | Radiation Control, Radionuclides | docx | Download | form | radiation-control radionuclides |
RN787 | App_Renewal or new source authority | Form | 2021 Dec
| 1 | Radiation Control, Radionuclides | docx | Download | form | radiation-control radionuclides |
RN787A | List of premises & rooms | Form | 2021 Dec
| 1 | Radiation Control, Radionuclides | docx | Download | form | radiation-control radionuclides |
RN788 | Temp Use Loan | Form | 2021 Dec
| 1 | Radiation Control, Radionuclides | docx | Download | form | radiation-control radionuclides |
RN789 | App_ Convey only | Form | 2021 Dec
| 1 | Radiation Control, Radionuclides | docx | Download | form | radiation-control radionuclides |
RN855 | App_Maintenance work on apparatus with sealed RS | Form | 2021 Dec
| 1 | Radiation Control, Radionuclides | docx | Download | form | radiation-control radionuclides |
RN800 | Notice of Complaint | Form | 2021 Dec
| 1 | Radiation Control, Radionuclides | docx | Download | form | radiation-control radionuclides |
RN900 | Incident Notification Form | Form | 2021 Dec
| 1 | Radiation Control, Radionuclides | docx | Download | form | radiation-control radionuclides |
OF-QA-09A | Guidelines Comments Form | Form | 2023 Jan
| 2 | Quality Management System | doc | Download | form | quality-management-system |