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Document NumberTitleCategoriesDate updatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
6.21Licence Application Medical Device Manufacture,

2016 Jul

1xlsDownloadapplication-forms formmedical-devices
6.12Complementary Medicines Section 21 Application Form

2013 Jul

1, Downloadapplication-formscomplementary-medicines section-21
GLF-CEM-PV-S01Valproate Annual Risk Acknowledgement Form

2022 Aug

1pdfDownloadformpharmacovigilance
OF-HPA-06ASAHPRA Pre-Submission Meeting Request Form

2021 Aug

2docxDownloadformgeneral-ectd-human-medicines-guidelines
OF-PEM-PRE-01JBioequivalence Trial Information Form (BTIF),

2022 Aug

4, docxDownloadform templatesgeneral-ectd-human-medicines-guidelines pharmaceutical-evaluation-management
OF-PEM-PRE-01HAdditional Strength Biowaiver Application Form,

2022 Aug

4, docxDownloadform templatesgeneral-ectd-human-medicines-guidelines pharmaceutical-evaluation-management
OF-PEM-PRE-01IBiopharmaceutics Classification System (BCS) Based Biowaiver Application Form,

2022 Aug

4, docxDownloadform templatesgeneral-ectd-human-medicines-guidelines pharmaceutical-evaluation-management
6.22Licence application to distribute (import/export) medical devices,

2016 Jul

1xlsDownloadapplication-forms formmedical-devices
6.26Licence application to wholesale medical devices,

2016 Nov

1pdfDownloadapplication-forms formmedical-devices
GLF-LIC-05AForm for Licence Application to Cultivate Manufacture or Import Cannabis for Medicinal Purposes,

2022 Aug

1, , , docxDownloadapplication-forms formcannabis inspectorate-and-good-manufacturing-practices licencing regulatory-compliance
GLF-LIC-01AForm for Licence Application to Manufacture Import or Export Medicines Scheduled Substances including Contract Testing Laboratories,

2022 Aug

1, docxDownloadapplication-forms forminspectorate-and-good-manufacturing-practices licencing
GLF-LIC-02ALicence Application to act as a Wholesaler of Medicines and Scheduled Substances,

2022 Aug

1, docxDownloadapplication-forms forminspectorate-and-good-manufacturing-practices licencing
GLF-LIC-04AForm for Licence Application for a Wholesaler to Export Medicines,

2022 Aug

1, docxDownloadapplication-forms forminspectorate-and-good-manufacturing-practices licencing
Application for possession/research or analytical purpose,

2020 Feb

1Downloadapplication-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),

2020 Apr

1Downloadapplication-forms formregulatory-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),

2020 Apr

1Downloadapplication-forms formregulatory-compliance
GLF-CEM-CT-01ENotification Studies: Phase IV,

2022 Sep

4docxDownloadapplication-forms formclinical-trials
GLF-CEM-CT-01AClinical Trial Application Form,

2022 Jun

7docxDownloadapplication-forms formclinical-trials
GLF-CEM-CT-01BClinical Trial Application Form – Guidance in conditions of a Public Health Emergency,

2022 Jun

2, docxDownloadapplication-forms formclinical-trials emergency-use
GLF-CEM-CT-01F2-Weekly Abridged Public Health Emergency Interim Progress Report Form for Clinical Trials,

2022 Sep

2docxDownloadform report-formsclinical-trials
GLF-CEM-CT-01C (CTF2)Application for a Protocol Amendment to an Approved Trial,

2022 Sep

4docxDownloadapplication-forms formclinical-trials
GLF-CEM-CT-01D (CTF3)Application for Additional Investigator(s) or Change of Investigator(s)/Sites and Application for Additional Sites,

2022 Sep

4docxDownloadapplication-forms formclinical-trials
GLF-CEM-CT-06ASix monthly progress report form,

2022 Jun

4docxDownloadform report-formsclinical-trials
6.36Investigators workload Form,

2020 Apr

3Downloadapplication-forms formclinical-trials
GLF-CEM-CT-01HSafety Reporting during Clinical Trial Form,

2022 Oct

4docxDownloadapplication-forms formclinical-trials
GLF-PEM-BIO-01AApplication Form for Lot Release of Human Vaccine,

2022 Sep

2pdfDownloadapplication-forms formbiological-medicines-evaluation-and-research
OF-GOV-01ARequest for access to record of held by SAHPRA (PAIA form)

2021 Apr

1docxDownloadformcorporate
GLF-CEM-PV-06AAdverse Drug Reactions and Quality Problem Reporting Form

2022 Aug

1pdfDownloadformpharmacovigilance
OF-PEM-VET-01DProgress Report Form After Use Of An Unregistered Product,

2022 Aug

1, , , docxDownloadform report-formsemergency-use section-21 unregistered-products veterinary-medicines
OF-PEM-VET-01EApplication form for unregistered veterinary medicines (Section 21),

2022 Aug

2, , docxDownloadapplication-forms formsection-21 unregistered-products veterinary-medicines
Owner Consent Form,

2019 Jul

2Downloadapplication-forms formveterinary-medicines
1.2.1Application For Registration Of A Medicine Module 1: Administrative Information Application Form,

2020 Feb

1Downloadapplication-forms formgeneral-ectd-human-medicines-guidelines
OF-PEM-VET-04BVeterinary Medicines Biowaiver Application Form for Parenterals

2022 Sept

1docxDownloadformveterinary-medicines
OF-PEM-VET-04ABioequivalence Trial Information for Veterinary Medicines

2022 Sept

1docxDownloadformveterinary-medicines
GLF-PEM-02ASubmission Form

2022 Oct

1docxDownloadformgeneral-ectd-human-medicines-guidelines
GLF-RDN-RN-14AMonthly Report – Sealed Sources

2022 Dec

1, pdfDownloadformradiation-control radionuclides
GLF-RDN-RN-15AMonthly Report – Unsealed Sources

2022 Dec

1, pdfDownloadformradiation-control radionuclides
RN523App_Liquid RA waste

2021 Dec

1, docxDownloadformradiation-control radionuclides
RN524App_Solid RA waste

2021 Dec

1, docxDownloadformradiation-control radionuclides
RN525App_Discard sealed sources

2021 Dec

1, docxDownloadformradiation-control radionuclides
RN525iApp_Discard sealed sources

2021 Dec

1, docxDownloadformradiation-control radionuclides
RN526App_Dispose of (sell) radionuclides

2021 Dec

1, docxDownloadformradiation-control radionuclides
RN527App_Change details

2021 Dec

1, docxDownloadformradiation-control radionuclides
RN607Medical report

2021 Dec

1, docxDownloadformradiation-control radionuclides
RN608Particulars of sealed radioactive sources

2021 Dec

1, docxDownloadformradiation-control radionuclides
RN621Application to release equipment from storage at NLM (NECSA)

2021 Dec

1, docxDownloadformradiation-control radionuclides
RN778App_Register industrial radiographer

2021 Dec

1, docxDownloadformradiation-control radionuclides
RN780Log for sealed gamma radiography sources

2021 Dec

1, docxDownloadformradiation-control radionuclides
GLF-RDN-RN-16AImport application

2022 Dec

1, pdfDownloadformradiation-control radionuclides
RN781aConfirmation of import

2021 Dec

1, docxDownloadformradiation-control radionuclides
GLF-RDN-RN-17AExport application

2022 Dec

1, pdfDownloadformradiation-control radionuclides
RN782aConfirmation of export

2021 Dec

1, docxDownloadformradiation-control radionuclides
RN785App_Change of RPO

2021 Dec

1, docxDownloadformradiation-control radionuclides
RN786App_Change of physicists

2021 Dec

1, docxDownloadformradiation-control radionuclides
RN786AApp_RPA Radiation Protection Adviser

2021 Dec

1, docxDownloadformradiation-control radionuclides
RN787App_Renewal or new source authority

2021 Dec

1, docxDownloadformradiation-control radionuclides
RN787AList of premises & rooms

2021 Dec

1, docxDownloadformradiation-control radionuclides
RN788Temp Use Loan

2021 Dec

1, docxDownloadformradiation-control radionuclides
RN789App_ Convey only

2021 Dec

1, docxDownloadformradiation-control radionuclides
RN855App_Maintenance work on apparatus with sealed RS

2021 Dec

1, docxDownloadformradiation-control radionuclides
RN800Notice of Complaint

2021 Dec

1, docxDownloadformradiation-control radionuclides
RN900Incident Notification Form

2021 Dec

1, docxDownloadformradiation-control radionuclides
OF-QA-09AGuidelines Comments Form

2023 Jan

2docDownloadformquality-management-system