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Document NumberTitleCategoriesDate UpdatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
GLF-MD-11AMedical Device Adverse Event Reporting Form, 13/12/20241docxDownloadapplication-forms formmedical-devices
GLF-PEM-02LSameness Declaration Form for Reliance-based Models20/08/20241, , docxDownloadformgeneral-ectd-human-medicines-guidelines hpa pem
GLF-HPA-06BCTD Checklist23/07/20241docxDownloadformgeneral-ectd-human-medicines-guidelines
GLF-HPA-06AZ-Code Request Form23/07/20241docxDownloadformgeneral-ectd-human-medicines-guidelines
GLF-LIC-05BLicence Application for the Importing and the Distribution Scheduled Substances, 24/04/20241, docxDownloadapplication-forms forminspectorate-and-good-manufacturing-practices licencing
GLF-PEM-VET-01CSection 21 Emergency Medicines Bulk Application Form, 22/03/20242, , docxDownloadapplication-forms formsection-21 unregistered-products veterinary-medicines
GLF-RDN-RN-02AApplication Form of The Renewal of Authority to Acquire, Possess, Use, Convey and/or Distribute Radioactive Nuclides29/02/20241, docxDownloadformradiation-control radionuclides
GLF-RC-INSP-05CPost recall information/FINAL REPORT to SAHPRA30/01/20242docxDownloadformregulatory-compliance
GLF-RC-INSP-05BRecall Letter to customers, 30/01/20242docxDownloadform templatesregulatory-compliance
GLF-RC-INSP-05ARecall Information30/01/20242docxDownloadformregulatory-compliance
ALL VACCINES including COVID-19 : Case Reporting Form (CRF) for Adverse Events Following Immunisation (AEFI)29/01/20211pdfDownloadformpharmacovigilance
COVID-19: Case Reporting Form (CRF) for suspected Adverse Events of Special Interest (AESI)28/01/20211pdfDownloadformpharmacovigilance
ALL VACCINES including COVID-19: Case Investigation Form (CIF) Adverse Events Following Immunisation (AEFI) AND Adverse Events of Special Interest (AESI)28/01/20211pdfDownloadformpharmacovigilance
VMRF1Veterinary Medicines Registration form16/09/20221docxDownloadformveterinary-medicines
GLF-PEM-02ELetter of Access for Reliance26/05/20231, , docxDownloadformgeneral-ectd-human-medicines-guidelines pem-pre-reg pharmaceutical-evaluation-management
GLF-RDN-RN-07I (Previously RN528)Application for Cancellation of Authority to Handle Radioactive Material20/05/20242, docxDownloadformradiation-control radionuclides
GLF-RDN-NM-06B (Previously SBVETMR-1)Application for a Licence to Use, Operate, Apply Install or Keep Installed an MRI Device System (Veterinary)18/11/20242, docxDownloadformnirmed radiation-control
GLF-RND-NM-06C (Previously SBMR-1)Application for a Licence to Use Operate Apply Install or Keep Installed a Magnetic Resonance Imaging (MRI) Device System (Medical)18/11/20242, docxDownloadformnirmed radiation-control
SBLN-1Application for a licence to use a non-medical laser21/03/20181, docDownloadformnirmed radiation-control
SBLM-1Application for a licence to use a medical laser20/03/20181, docDownloadformnirmed radiation-control
GLF-RDN-NM-01AApplication for Licence to Import a New Listed Electromagnetic Product18/11/20242, docxDownloadformnirmed radiation-control
GLF-RDN-NM-01BApplication for a Licence to Import Listed Electronic Product (Non Medical)08/03/20231, docxDownloadformnirmed radiation-control
GLF-RDN-NM-01CApplication for a Licence to Manufacture a Listed Electromagnetic Product (Non Medical) in South Africa08/03/20231, docxDownloadformnirmed radiation-control
GLF-RDN-NM-01DApplication for a Licence to Import for a Fully Refurbished Electronic Product08/03/20231, docxDownloadformnirmed radiation-control
GLF-RDN-XR-25DDetails of transaction for a therapeutic particle accelerator16/02/20231, docxDownloadformradiation-control x-rays
GLF-RDN-XR-24GApplication for a licence to manufacture a listed electromedical device SA09/02/20231, docxDownloadformradiation-control x-rays
GLF-RDN-XR-24FApplication for a licence to import a listed electronic product15/02/20231, docxDownloadformradiation-control x-rays
GLF-RDN-XR-24EApplication for a licence to import a fully refurbished listed electromedical device16/02/20231, docxDownloadformradiation-control x-rays
GLF-RDN-XR-24DApplication for a licence to manufacture or fully refurbish a listed electromedical device SA16/02/20231, docxDownloadformradiation-control x-rays
GLF-RDN-XR-24CApplication for a licence to import a new listed electronic product16/02/20231, docxDownloadformradiation-control x-rays
GLF-RDN-XR-24BApplication for a licence to conduct clinical trials on locally manufactured listed electromedical product23/02/20231, docxDownloadformradiation-control x-rays
GLF-RDN-XR-24AApplication for a licence to import a listed electromedical product to conduct clinical trials09/02/20231, docxDownloadformradiation-control x-rays
GLF-RDN-XR-16A (Previously RC013)Application To Register As An Industrial Radiographer (X-ray Radiography)12/04/20231, docxDownloadformradiation-control x-rays
GLF-RDN-XR-03BApplication For Exemption From Personal Monitoring: Dental Radiography12/04/20231, docxDownloadformradiation-control x-rays
GLF-RDN-XR-02DApplication Re-activate Licence For Stored Cancelled Electronic Product18/08/20221, docxDownloadformradiation-control x-rays
GLF-RDN-XR-02CResponsible Person18/08/20221, docxDownloadformradiation-control x-rays
GLF-RDN-XR-02BApplication For A Licence To Use An X-ray Device13/08/20221, docxDownloadformradiation-control x-rays
GLF-RDN-XR-02AApplication Disposal Of A Licensed Electronic Product And Or New/ Modified Premises18/08/20221, docxDownloadformradiation-control x-rays
GLF-RDN-XR-25AApplication for a licence to use a therapeutic device in terms of article 4(1)(b) AND 4(1)(c)08/02/20231, docxDownloadformradiation-control x-rays
GLF-RDN-XR-25BChange appointment of responsible person or medical08/02/20231, docxDownloadformradiation-control x-rays
GLF-RDN-XR-25CDisposal modification of a therapeutic device or particle accelerator and or new modified premises23/02/20231, docxDownloadformradiation-control x-rays
GLF-RDN-XR-03AApplication for a Licence to Use as Per Condition 03 of Your Licence to Import or Manufacture15/02/20231, docxDownloadformradiation-control x-rays
GLF-RDN-XR-02GApplication form for a Licence to Install and Use an X-Ray Device and Related Components16/02/20231, docxDownloadformradiation-control x-rays
GLF-RDN-XR-02EApplication Form for Appointment, Termination of a Medical Physicist for Interventional Radiology15/02/20231, docxDownloadformradiation-control x-rays
GLF-RDN-XR-10ANotification of Radiation Occurrence08/02/20231, docxDownloadformradiation-control x-rays
OF-QA-09AGuidelines Comments Form04/01/20232docDownloadformquality-management-system
RN900Incident Notification Form07/12/20211, Downloadformradiation-control radionuclides
GLF-RDN-RN-07E (Previously RN800)Notice of Complaint20/05/20242, docxDownloadformradiation-control radionuclides
RN855App_Maintenance work on apparatus with sealed RS07/12/20211, Downloadformradiation-control radionuclides
GLF-RDN-RN-14B (Previously RN789)Application to convey or transport radionuclides26/07/20242, docxDownloadformradiation-control radionuclides
(Previously RN788)Application for Authority for the Temporary Use, Possession and Transport of Equipment Containing Radionuclides, Downloadformradiation-control radionuclides
GLF-RDN-RN-07A (Previously RN787)Application to Acquire Use Possess Radionuclides20/05/20242, docxDownloadformradiation-control radionuclides
RN786AApp_RPA Radiation Protection Adviser07/12/20211, Downloadformradiation-control radionuclides
WIF-RDN-RN-02B.I (Previously RN786)Application for Change of Physicist26/07/20242, docxDownloadformradiation-control radionuclides
RN785App_Change of RPO07/12/20211, Downloadformradiation-control radionuclides
GLF-RDN-RN-07H (Previously RN782a)Confirmation of Export of Sources20/05/20242, docxDownloadformradiation-control radionuclides
GLF-RDN-RN-17A (Previously RN782)Export application07/12/20221, docxDownloadformradiation-control radionuclides
GLF-RDN-RN-07C (Previously RN781a)Confirmation of Import of Sources20/05/20241, docxDownloadformradiation-control radionuclides
GLF-RDN-RN-16A (Previously RN781)Import application07/12/20221, docxDownloadformradiation-control radionuclides
RN780Log for sealed gamma radiography sources07/12/20211, Downloadformradiation-control radionuclides
RN778App_Register industrial radiographer13/12/20211, Downloadformradiation-control radionuclides
GLF-RDN-RN-07J (Previously RN621)Application to Release Old Sealed Sources from NLM NECSA Storage20/05/20241, docxDownloadformradiation-control radionuclides
RN608Particulars of sealed radioactive sources08/12/20211, Downloadformradiation-control radionuclides
RN607Medical report08/12/20211, docxDownloadformradiation-control radionuclides
GLF-RDN-RN-07B (Previously RN527 & RN787A)Application for a Change of Details of an Authority Holder and Physical Facilities for the Handling, Use and Storage of Unsealed Radionuclides20/05/20242, docxDownloadformradiation-control radionuclides
WIF-RDN-RN-02B.H (Previously RN526)Application for disposal sale of radionuclides26/07/20242, docxDownloadformradiation-control radionuclides
RN525iApp_Discard sealed sources09/12/20211, docxDownloadformradiation-control radionuclides
WIF-RDN-RN-02B.G (Previously RN525)Application to discard remove sealed radioactive sources26/07/20242, docxDownloadformradiation-control radionuclides
WIF-RDN-RN-02B.F (Previously RN524)Application to discard dispose sealed radioactive material26/07/20242, docxDownloadformradiation-control radionuclides
WIF-RDN-RN-02B.E (Previously RN523)Application to dispose of liquid radioactive material26/07/20242, docxDownloadformradiation-control radionuclides
GLF-RDN-RN-15A (Previously RN002)Monthly Report – Unsealed Sources07/12/20221, docxDownloadformradiation-control radionuclides
GLF-RDN-RN-14A (Previously RN001)Monthly Report – Sealed Sources07/12/20221, docxDownloadformradiation-control radionuclides
GLF-PEM-02ASubmission Form Template01/07/20242docxDownloadformgeneral-ectd-human-medicines-guidelines
OF-PEM-VET-04ABioequivalence Trial Information for Veterinary Medicines16/09/20221docxDownloadformveterinary-medicines
OF-PEM-VET-04BVeterinary Medicines Biowaiver Application Form for Parenterals07/09/20221docxDownloadformveterinary-medicines
GLF-BAU-HPA-07AMedicines Application Form Module 1.2.1, 18/05/20237docxDownloadapplication-forms formgeneral-ectd-human-medicines-guidelines
GLF-PEM-VET-05BOwner Consent Form (Use of an Unregistered Veterinary Product), 26/08/20241docxDownloadapplication-forms formveterinary-medicines
OF-PEM-VET-01CVeterinary Clinical Trial Application Template, , 26/08/20243, docxDownloadapplication-forms form templatesclinical-trials veterinary-medicines
GLF-PEM-VET-01AVeterinary Medicines Section 21 Application Form, 22/03/20242, , docxDownloadapplication-forms formsection-21 unregistered-products veterinary-medicines
GLF-PEM-VET-01BProgress Report Form After Use of An Unregistered Product, 22/03/20243, , , docxDownloadform report-formsemergency-use section-21 unregistered-products veterinary-medicines
GLF-CEM-PV-06AAdverse Drug Reactions and Quality Problem Reporting Form22/11/20233pdfDownloadformpharmacovigilance
OF-GOV-01ARequest for access to record of held by SAHPRA (PAIA form)08/04/20211docxDownloadformcorporate
GLF-PEM-BIO-01AApplication Form for Lot Release of Human Vaccine, 08/06/20233pdfDownloadapplication-forms formbiological-medicines-evaluation-and-research
GLF-CEM-CT-01HSafety Reporting during Clinical Trial Form, 13/10/20224docxDownloadapplication-forms formclinical-trials
6.36Investigators workload Form, 22/04/20203Downloadapplication-forms formclinical-trials
GLF-CEM-CT-01GSix monthly progress report form, 22/09/20225docxDownloadform report-formsclinical-trials
GLF-CEM-CT-01D (CTF3)Application for Additional Investigator(s) or Change of Investigator(s)/Sites and Application for Additional Sites, 15/09/20224docxDownloadapplication-forms formclinical-trials
GLF-CEM-CT-01C (CTF2)Application for a Protocol Amendment to an Approved Trial, 15/09/20224docxDownloadapplication-forms formclinical-trials
GLF-CEM-CT-01F2-Weekly Abridged Public Health Emergency Interim Progress Report Form for Clinical Trials, 07/09/20222docxDownloadform report-formsclinical-trials
GLF-CEM-CT-01BClinical Trial Application Form – Guidance in conditions of a Public Health Emergency, 08/06/20222, docxDownloadapplication-forms formclinical-trials emergency-use
GLF-CEM-CT-01AClinical Trial Application Form, 18/09/20228docxDownloadapplication-forms formclinical-trials
GLF-CEM-CT-01ENotification Studies: Phase IV, 01/10/20235docxDownloadapplication-forms formclinical-trials
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), 15/04/20201Downloadapplication-forms formregulatory-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), 10/04/20201Downloadapplication-forms formregulatory-compliance
Application for possession/research or analytical purpose, 12/02/20201Downloadapplication-forms formregulatory-compliance
GLF-LIC-04AForm for Licence Application for a Wholesaler to Export Medicines, 18/08/20221, docxDownloadapplication-forms forminspectorate-and-good-manufacturing-practices licencing
GLF-LIC-02ALicence Application to act as a Wholesaler of Medicines and Scheduled Substances, 18/08/20221, docxDownloadapplication-forms forminspectorate-and-good-manufacturing-practices licencing
GLF-LIC-01AForm for Licence Application to Manufacture Import or Export Medicines Scheduled Substances including Contract Testing Laboratories, 18/08/20221, docxDownloadapplication-forms forminspectorate-and-good-manufacturing-practices licencing
GLF-LIC-05AForm for Licence Application to Cultivate Manufacture or Import Cannabis for Medicinal Purposes, 10/08/20221, , , docxDownloadapplication-forms formcannabis inspectorate-and-good-manufacturing-practices licencing regulatory-compliance
GLF-MD-06BLicence Application Medical Device Wholesaler Form, 03/09/20244xlsxDownloadapplication-forms formmedical-devices
GLF-MD-06CLicence Application to Import Distribute or Export Medical Devices, 03/09/20244xlsxDownloadapplication-forms formmedical-devices
OF-PEM-PRE-01IBiopharmaceutics Classification System (BCS) Based Biowaiver Application Form12/08/20224, , docxDownloadformgeneral-ectd-human-medicines-guidelines pem-pre-reg pharmaceutical-evaluation-management
OF-PEM-PRE-01HAdditional Strength Biowaiver Application Form18/08/20224, , docxDownloadformgeneral-ectd-human-medicines-guidelines pem-pre-reg pharmaceutical-evaluation-management
OF-PEM-PRE-01JBioequivalence Trial Information Form (BTIF)19/08/20224, , docxDownloadformgeneral-ectd-human-medicines-guidelines pem-pre-reg pharmaceutical-evaluation-management
OF-HPA-06ASAHPRA Pre-Submission Meeting Request Form05/08/20212, docxDownloadformgeneral-ectd-human-medicines-guidelines hpa
GLF-CEM-PV-S01Valproate Annual Risk Acknowledgement Form18/08/20221pdfDownloadformpharmacovigilance
GLF-PEM-COMP-01AComplementary Medicines Section 21 Application Form07/08/20241, docxDownloadapplication-formscomplementary-medicines section-21
GLF-MD-06ALicence Application Medical Device Manufacture, 03/09/20244xlsxDownloadapplication-forms formmedical-devices