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Document NumberTitleCategoriesDate updatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
6.21Licence Application Medical Device Manufacture,

2016 Jul

1Downloadapplication-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

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

2016 Nov

1Downloadapplication-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
6.37Safety Reporting during Clinical Trial Form,

2020 Apr

3Downloadapplication-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