| 6.21 | Licence Application Medical Device Manufacture | Application forms, Form | 2016 Jul
| 1 | Medical Devices | xls | Download | application-forms form | medical-devices |
| 8.02 | Medical Device IVD Essential Principles | Guideline | 2019 Nov
| 2 | Medical Devices | | Download | guideline | 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 |
| 7.01 | Complementary Medicines – Discipline Specific Safety and efficacy | Guideline | 2020 Jan
| 3 | Complementary Medicines | pdf | Download | guideline | complementary-medicines |
| 9.126 | Reflection document on regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2 | Communication to industry | 2021 May
| 1 | Biological Medicines Evaluation and Research | | Download | communication-to-industry | biological-medicines-evaluation-and-research |
| SAHPGL-CEM-NS-03 | Guideline for proprietary names for medicines | Guideline | 2022 May
| 7 | Names and Scheduling | pdf | Download | guideline | names-and-scheduling |
| 2.30 | Biosimilar Medicines Guidance | Guideline | 2014 Aug
| 3 | Biological Medicines Evaluation and Research | | Download | guideline | biological-medicines-evaluation-and-research |
| SAHPGL-CEM-NS-02 | Guideline to the scheduling of substances and medicines | Guideline | 2022 May
| 3 | Names and Scheduling | pdf | Download | guideline | names-and-scheduling |
| SAHPGL-CEM-NS-04 | Scheduling of substances for prescribing by authorised prescribers other than medical practitioners or dentists | Guideline | 2022 May
| 3 | Names and Scheduling | pdf | Download | guideline | names-and-scheduling |
| SAHPGL-PEM-BIO-03 | Guideline for Pre-Registration Consultation Meeting | Guideline | 2022 Sep
| 2 | Biological Medicines Evaluation and Research | pdf | Download | guideline | biological-medicines-evaluation-and-research |
| SAHPGL-PEM-BIO-04 | Biological medicines stability Guideline | Guideline | 2022 Aug
| 2 | Biological Medicines Evaluation and Research | pdf | Download | guideline | biological-medicines-evaluation-and-research |
| SAHPGL-PEM-BIO-05 | Biological Medicines Amendment guideline | Guideline | 2022 Sep
| 5 | Biological Medicines Evaluation and Research | pdf | Download | guideline | biological-medicines-evaluation-and-research |
| Industry Communication on Interim Measures Pending Update of Variation Addendum | Communication to industry, Guideline | 2020 Sep
| 1 | General ECTD & human medicines | pdf | Download | communication-to-industry guideline | general-ectd-human-medicines-guidelines |
| 2.01 | General information guideline | Guideline | 2019 Jul
| 10 | General ECTD & human medicines | | Download | guideline | general-ectd-human-medicines-guidelines |
| 2.02 | Quality and Bioequivalence | Guideline | 2019 Jul
| 7 | General ECTD & human medicines | | Download | guideline | general-ectd-human-medicines-guidelines |
| SAHPGL-HPA-06 | Variations Addendum For Human And Veterinary Medicines | Guideline | 2022 Sep
| 6 | General ECTD & human medicines, Veterinary medicines | pdf | Download | guideline | general-ectd-human-medicines-guidelines veterinary-medicines |
| SAHPGL-CEM-01 | Clinical guideline | Guideline | 2022 Aug
| 3 | Clinical Evaluations Management, General ECTD & human medicines | pdf | Download | guideline | clinical-evaluations-management general-ectd-human-medicines-guidelines |
| SAHPGL-CEM-03 | Guideline for Patient Information Leaflet for Human Medicines (Categories A D) | Guideline | 2022 oct
| 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-02 | Guideline for Professional Information for Human Medicines (Categories A and D) | Guideline | 2022 Sept
| 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 |
| SAHGPL-HPA-03 | eCTD Validation Criteria | Guideline | 2022 Nov
| 4 | General ECTD & human medicines | pdf | Download | guideline | general-ectd-human-medicines-guidelines |
| 2.23 | Guideline for submission in eCTD format | Guideline | 2019 Jul
| 3 | General ECTD & human medicines | | Download | guideline | general-ectd-human-medicines-guidelines |
| 2.58 | Submission in eSubmission format | Guideline | 2019 Jul
| 1 | General ECTD & human medicines | | Download | guideline | general-ectd-human-medicines-guidelines |
| SAHPGL-PEM-03 | Guideline for the API Master File (APIMF) Procedure | Guideline | 2022 Nov
| 3 | General ECTD & human medicines, Pharmaceutical Evaluation Management, Pre-Reg | pdf | Download | guideline | general-ectd-human-medicines-guidelines pharmaceutical-evaluation-management pre-reg |
| SAHPGL-PEM-01 | Availability of medicines for use in a Public Health Emergency (PHE) | Guideline | 2022 Jun
| 2 | 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-INSP-02 | Guideline for Good Manufacturing Practice | Guideline | 2022 Sep
| 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 |
| 5.08 | Reliance Guideline | Guideline | 2022 Mar
| 3 | General ECTD & human medicines | | Download | guideline | general-ectd-human-medicines-guidelines |
| SAHPGL-HPA-05 | BAU Variations Communication | Communication to industry, Guideline | 2022 Sep
| 4 | General ECTD & human medicines | pdf | Download | communication-to-industry guideline | general-ectd-human-medicines-guidelines |
| 9.127 | eCTD Implementation roadmap communication | Communication to industry | 2021 Oct
| 2 | General ECTD & human medicines | | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
| 9.128 | Pilot: BAU new medicine applications for registration | Communication to industry | 2021 Jul
| 2 | General ECTD & human medicines | | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
| 9.129 | Re-submission of BAU New Medicines Applications from 2018 and 2019 | Communication to industry | 2021 Oct
| 2 | General ECTD & human medicines | | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
| 7.02 | Roadmap for CMs | Guideline | 2021 Dec
| 2 | Complementary Medicines | pdf | Download | guideline | complementary-medicines |
| 7.03 | Complementary Medicines – Use of the ZA-CTD format in the preparation of registration applications | Guideline | 2020 Jun
| 3 | Complementary Medicines | pdf | Download | guideline | complementary-medicines |
| 7.04 | Complementary Medicines – Health Supplements Safety and Efficacy | Guideline | 2022 Mar
| 4 | Complementary Medicines | pdf | Download | guideline | complementary-medicines |
| 7.05 | Complementary Medicines Registration Application ZA-CTD-Quality | Guideline | 2020 Jun
| 2 | Complementary Medicines | pdf | Download | guideline | complementary-medicines |
| 7.06 | CMs Specified Substances | Guideline | 2022 Jan
| 3 | Complementary Medicines | pdf | Download | guideline | complementary-medicines |
| 5.08 | Revised Guideline – Donations of Medicines Medical Devices And IVDs | Other documents | 2020 Apr
| 3 | Medical Devices | pdf | Download | other-documents | medical-devices |
| 8.04 | Recalls Vigilance Medical Devices IVDs | Guideline | 2019 Nov
| 3 | Medical Devices | pdf | Download | guideline | medical-devices |
| 8.05 | CLASSIFICATION of MEDICAL DEVICES and IVDs | Guideline | 2021 Aug
| 5 | Medical Devices | pdf | Download | guideline | medical-devices |
| 8.07 | Medical Device Quality Manual | Guideline | 2019 Nov
| 2 | Medical Devices | pdf | Download | guideline | medical-devices |
| MD004 | Extension – Use of acknowledgement letter in lieu of a licence | Communication to industry | 2020 Mar
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD010 | Guidance Rapidly developed ventilator | Communication to industry | 2020 May
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 16.03 | Licence Medical Devices IVDs | Guideline | 2019 Nov
| 3 | Medical Devices | pdf | Download | guideline | medical-devices |
| Section 21 Access to Unregistered Medicines – IVERMECTIN CONTROLLED COMPASSIONATE USE PROGRAMME | Communication to industry, Guideline | 2022 May
| 2 | Emergency use, Section 21, Unregistered products | www | Download | communication-to-industry guideline | emergency-use section-21 unregistered-products |
| SAHPGL-CEM-S21-02 | Guideline For Section 21 Access To Unregistered Medicines | Guideline | 2022 Aug
| 4 | Emergency use, Section 21, Unregistered products | pdf | Download | guideline | emergency-use section-21 unregistered-products |
| SAHPGL-INSP-01 | Guideline for Post Importation Testing | Guideline | 2022 Sep
| 5 | Inspectorate and good manufacturing practices | pdf | Download | guideline | inspectorate-and-good-manufacturing-practices |
| SAHPGL-INSP-03 | Guideline for Good Wholesaling Practice for Wholesaler | Guideline | 2022 Sep
| 5 | Inspectorate and good manufacturing practices, Licencing | pdf | Download | guideline | inspectorate-and-good-manufacturing-practices licencing |
| SAHPGL-INSP-04 | Guideline for preparation of site master file | Guideline | 2022 Sep
| 5 | Inspectorate and good manufacturing practices, Licencing | pdf | Download | guideline | inspectorate-and-good-manufacturing-practices licencing |
| SAHPGL-INSP-05 | Guideline on how to respond to a GMP, GWP, GCP and GVP Inspection report | Guideline | 2022 Sep
| 2 | Inspectorate and good manufacturing practices | pdf | Download | guideline | inspectorate-and-good-manufacturing-practices |
| SAHPGL-INSP-06 | Guideline for Fee determination and Payment of GxP and Product related Inspection | Guideline | 2022 Sep
| 2 | Inspectorate and good manufacturing practices | pdf | Download | guideline | inspectorate-and-good-manufacturing-practices |
| SAHPGL-LIC-01 | Licence to Manufacture, Import or Export | Guideline | 2022 Jun
| 3 | Licencing | pdf | Download | guideline | licencing |
| SAHPGL-INSP-RC-02 | Guideline for the Importation and Exportation of Medicines | Guideline | 2022 Jun
| 2 | Regulatory Compliance | pdf | Download | guideline | regulatory-compliance |
| SAHPGL-INSP-RC-12 | Guideline On How To Lodge A Complaint On Medicines And Medical Devices | Guideline | 2022 Nov
| 4 | Regulatory Compliance | pdf | Download | guideline | regulatory-compliance |
| SAHPGL-CEM-PV-06 | Guideline For Adverse Drug Reactions (ADRs) Reporting for Healthcare Professionals | Guideline | 2022 Aug
| 3 | pharmacovigilance | pdf | Download | guideline | pharmacovigilance |
| GLF-CEM-PV-S01 | Valproate Annual Risk Acknowledgement Form | Form | 2022 Aug
| 1 | pharmacovigilance | pdf | Download | form | pharmacovigilance |
| SAHPGL-CEM-PV-05 | Guideline for the handling of Dear Healthcare Professional Letters relating to medicine safety | Guideline | 2022 Aug
| 6 | pharmacovigilance | pdf | Download | guideline | pharmacovigilance |
| SA GCP Guidelines | Guideline | 2020 Jun
| 3 | Clinical Trials | | Download | guideline | clinical-trials |
| Clinical Trials Committee and Submission dates for 2022 | Communication to industry | 2021 Jun
| 1 | Clinical Trials | pdf | Download | communication-to-industry | clinical-trials |
| SAHPGL-CEM-CT-10 | Safety Reporting During Clinical Trials | Guideline | 2022 Oct
| 5 | Clinical Trials | pdf | Download | guideline | clinical-trials |
| SAHPGL-CEM-CT-03 | Emergency Procedures for Clinical Trial Sites | Guideline | 2022 Aug
| 3 | Clinical Trials | pdf | Download | guideline | clinical-trials |
| SAHPGL-CEM-CT-07 | Post Clinical Trial Access | Guideline | 2022 Aug
| 4 | Clinical Trials | pdf | Download | guideline | clinical-trials |
| SAHPGL-CEM-CT-04 | Oversight and Monitoring in Clinical Trials | Guideline | 2022 Aug
| 4 | Clinical Trials | pdf | Download | guideline | clinical-trials |
| SAHPGL-CEM-CT-08 | Guideline for Capacity Building and Transformation in Clinical Research in South Africa | Guideline | 2022 Oct
| 2 | Clinical Trials | pdf | Download | guideline | clinical-trials |
| SAHPGL-CEM-CT-02 | Clinical Trial Participant Time, Inconvenience and Expense (TIE) Compensation Model | Guideline | 2022 Jul
| 2 | Clinical Trials | pdf | Download | guideline | clinical-trials |
| SAHPGL-CEM-CT-05 | Liability Insurance for Clinical Trials | Guideline | 2022 Aug
| 3 | Clinical Trials | pdf | Download | guideline | clinical-trials |
| SAHPGL-CEM-CT-06 | Procedure for Consultation Meetings with Clinical Trial Applicants | Guideline | 2022 Aug
| 2 | Clinical Trials | pdf | Download | guideline | clinical-trials |
| SAHPGL-CEM-CT-01 | Guideline For Electronic Submission of Clinical Trial Documents (Amendments, Bioequivalence Studies, Responses, Notifications, And Serious Adverse Events) | Communication to industry, Guideline | 2022 Sept
| 3 | Clinical Trials | pdf | Download | communication-to-industry guideline | clinical-trials |
| SAHPGL-CEM-CT-09 | Guideline for Clinical Trial Investigators | Communication to industry, Guideline | 2022 Oct
| 3 | Clinical Trials | pdf | Download | communication-to-industry guideline | clinical-trials |
| 17.05 | SAHPRA Payment Guideline | Guideline | 2022 Sept
| 7 | Finance | pdf | Download | guideline | finance |
| SAHPRA INVOLVEMENT IN THE SWISSMEDIC MARKETING AUTHORISATION FOR GLOBAL HEALTH PRODUCTS (MAGHP) PROCEDURE | Communication to industry | 2021 Nov
| 1 | General ECTD & human medicines | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
| 2.17 | Communication to industry on the sartans-containing medicines | Communication to industry | 2020 Oct
| 2 | General ECTD & human medicines | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
| 2.18 | Communication to industry on ranitidine-containing medicines | Communication to industry | 2020 Oct
| 1 | General ECTD & human medicines | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
| 2.19 | Communication to industry on metformin-containing medicines | Communication to industry | 2020 Oct
| 1 | General ECTD & human medicines | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
| Communication to industry on Clones and Replicas | Communication to industry | 2020 Nov
| 1 | General ECTD & human medicines | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
| 7.02 | updated – Roadmap and transitional process for the Regulation of complementary medicines | Communication to industry | 2021 Dec
| 1 | Complementary Medicines | pdf | Download | communication-to-industry | complementary-medicines |
| Application for a certificate of free sale for Category D medicines (Complementary Medicines) | Communication to industry | 2021 Nov
| 1 | Complementary Medicines | pdf | Download | communication-to-industry | complementary-medicines |
| Review of detained product at a port of entry as a Category D medicine | Communication to industry | 2021 Oct
| 1 | Complementary Medicines | pdf | Download | communication-to-industry | complementary-medicines |
| REQUESTS: Existing Category D (Complementary Medicines) Registration Applications – COMPLEMENTARY MEDICINES APPLICATIONS SUBMITTED FOR REGISTRATION | Communication to industry | 2021 Oct
| 1 | Complementary Medicines | pdf | Download | communication-to-industry | complementary-medicines |
| Communication to Stakeholders: Licensing of Complementary Medicines Manufacturers, Wholesalers, Distributors, Importers and Exporters | Communication to industry | 2020 Feb
| 1 | Complementary Medicines | pdf | Download | communication-to-industry | complementary-medicines |
| MD001 | Regulatory Requirements for Medical Devices COVID-19 | Communication to industry | 2020 Jul
| 2 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD002 | Regulatory Requirements for Serological Test Kits | Communication to industry | 2020 Jul
| 2 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD003 | Testing for COVID-19 | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD005 | Expedited Regulatory Pathways for Medical Devices | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD006 | Laboratory Testing and Use of COVID-19 Serological Test Kits | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD007 | Specifications Serological Test kits | Communication to industry | 2020 Jul
| 2 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD008 | ISO Standards for Medical Devices and Protective Clothing | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD009 | Alternative Regulatory Licensing Requirements Alcohol-based sanitisers | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD011 | Licence Conditions for COVID-19 Serological Test Kits | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD012 | Notice of Contravention of Act 101 of 1965 | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD013 | Process Flow Locally Manufactured COVID-19 Test Kits | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD014 | Regulatory Requirements for Molecular Test Kits | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD015 | Process Flow Imported COVID-19 Test Kits | Communication to industry | 2022 Mar
| 2 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD016 | Conditions of Use COVID-19 Serological Test Kits | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD017 | Technical Review Application COVID-19 Molecular Test | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD018 | Specifications Molecular Test kits | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD019 | Processing of licence applications | Communication to industry | 2020 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD020 | Certificate of Free Sale | Communication to industry | 2020 Jul
| 2 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD021 | Use SARS CoV-2 Antibody Tests NDOH | Communication to industry | 2020 Aug
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD022 | Application Clinical Evaluation Medical Device IVD | Communication to industry | 2020 Aug
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD024 | Frequently asked questions: Performance evaluation of point-of-care COVID-19 serology antibody test kits | Communication to industry | 2020 Sep
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD025 | Licensing and Regulatory requirements for the manufacture and distribution of medical and respirator masks during Covid-19 | Communication to industry | 2020 Sep
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD025 | Alternative licensing and regulatory pathway for masks | Communication to industry | 2020 Sep
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD027 | Section 21 Authorisation for the Importation of Research Use Only (RUO) In Vitro Diagnostic Devices (IVDs) | Communication to industry | 2021 Mar
| 1 | Medical Devices | docx | Download | communication-to-industry | medical-devices |
| MD028 | Communication Retention Fees | Communication to industry | 2021 May
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD029 | Renewal of Section 21 Authorisation for use of unregistered rapidly developed non-invasive ventilators | Communication to industry | 2021 Jun
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 8.04 | Contact details for Guideline 8.04 Recall, Adverse Event And Post- Marketing Vigilance Reporting Of Medical Devices And IVDs | Communication to industry | 2021 Dec
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| GMP CERTIFICATES FOR CANNABIS CULTIVATED BY CULTIVATORS HOLDING A SECTION 22C(1)(b) LICENCE (LICENCE TO CULTIVATE CANNABIS FOR THE PURPOSES OF PRODUCING SCHEDULED SUBSTANCES) | Communication to industry | 2021 Mar
| 1 | Inspectorate and good manufacturing practices, Licencing | pdf | Download | communication-to-industry | inspectorate-and-good-manufacturing-practices licencing |
| SAHPRA survey to determine company turnover | Communication to industry | 2021 Mar
| 1 | Inspectorate and good manufacturing practices, Licencing | pdf | Download | communication-to-industry | inspectorate-and-good-manufacturing-practices licencing |
| Communication to industry on Post Marketing Reporting of ADRs guideline | Communication to industry | 2021 May
| 1 | pharmacovigilance | pdf | Download | communication-to-industry | pharmacovigilance |
| A SIGNAL OF MYOCARDITIS / PERICARDITIS ASSOCIATED WITH PFIZER-BIONTECH’S COVID-19 VACCINE, COMIRNATY (BNT162B2) | Safety Alerts | 2021 Aug
| 1 | pharmacovigilance | pdf | Download | safety-alerts | pharmacovigilance |
| DIPHENHYDRAMINE-CONTAINING MEDICINES | Safety Alerts | 2020 Nov
| 1 | pharmacovigilance | pdf | Download | safety-alerts | pharmacovigilance |
| 21.8 | Communication to industry on ranitidine-containing medicines | Communication to industry, Safety Alerts | 2020 Oct
| 1 | pharmacovigilance | | Download | communication-to-industry safety-alerts | pharmacovigilance |
| 21.9 | Communication to industry on metformin-containing medicines | Communication to industry, Safety Alerts | 2020 Oct
| 1 | pharmacovigilance | | Download | communication-to-industry safety-alerts | pharmacovigilance |
| 21.5 | MSA gamma benzine hexachloride | Safety Alerts | 2012 Jun
| 1 | pharmacovigilance | pdf | Download | safety-alerts | pharmacovigilance |
| 21.6 | MSA cough and cold medicines | Safety Alerts | 2012 Jun
| 1 | pharmacovigilance | pdf | Download | safety-alerts | pharmacovigilance |
| 21.4 | MSA atypical antipsychotics | Safety Alerts | 2009 Jun
| 2 | pharmacovigilance | pdf | Download | safety-alerts | pharmacovigilance |
| 21.2 | MSA promethazine | Safety Alerts | 2007 Sep
| 1 | pharmacovigilance | pdf | Download | safety-alerts | pharmacovigilance |
| 21.3 | MSA Rotarix | Safety Alerts | 2008 Mar
| 1 | pharmacovigilance | pdf | Download | safety-alerts | pharmacovigilance |
| 21.1 | MSA ketoconazole and domperidone | Safety Alerts | 2006 Jul
| 1 | pharmacovigilance | pdf | Download | safety-alerts | 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 |
| Notification Template 1 for Nitrosamine Risk Evaluation | Templates | 2021 Dec
| 1 | General ECTD & human medicines | | Download | templates | general-ectd-human-medicines-guidelines |
| Notification Template 2 for Nitrosamine Confirmatory Testing | Templates | 2021 Dec
| 1 | General ECTD & human medicines | | Download | templates | general-ectd-human-medicines-guidelines |
| Outcome of Risk for Nitrosamine Investigation | Templates | 2021 Dec
| 1 | General ECTD & human medicines | | Download | templates | general-ectd-human-medicines-guidelines |
| SAHPRA Variation Validation Template for eCTD | Templates | 2020 Feb
| 1 | General ECTD & human medicines | | Download | templates | general-ectd-human-medicines-guidelines |
| SAHPRA Variation Validation Template for eSubmission | Templates | 2020 Feb
| 1 | General ECTD & human medicines | | Download | templates | general-ectd-human-medicines-guidelines |
| 6.16 | New Registration Validation Template for eCTD | Templates | 2019 Jul
| 3 | General ECTD & human medicines | | Download | templates | general-ectd-human-medicines-guidelines |
| 6.30 | New Registration Validation Template for eSubmission | Templates | 2019 Jul
| 1 | General ECTD & human medicines | | Download | templates | general-ectd-human-medicines-guidelines |
| 6.31 | Summary of Critical Regulatory Elements (SCoRE) | Templates | 2020 Nov
| 3 | General ECTD & human medicines | | Download | templates | 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 |
| 6.33 | Abridged review template | Templates | 2019 Aug
| 2 | General ECTD & human medicines | | Download | templates | general-ectd-human-medicines-guidelines |
| 6.34 | Verified review template | Templates | 2019 Aug
| 2 | General ECTD & human medicines | | Download | templates | general-ectd-human-medicines-guidelines |
| 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 |
| 6.18 | Validation template CM | Templates | 2020 Jun
| 2 | Complementary Medicines | | Download | templates | complementary-medicines |
| 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 |
| Communication to Industry Licence Acknowledgement Letter | Communication to industry, Position statement | 2019 Nov
| 1 | Medical Devices | pdf | Download | communication-to-industry position-statement | medical-devices |
| Communication to Industry Licence Amendment | Communication to industry, Position statement | 2019 Nov
| 1 | Medical Devices | pdf | Download | communication-to-industry position-statement | medical-devices |
| Reprocessing of Single Use Medical Devices Communication to Stakeholders | Communication to industry, Position statement | 2019 Nov
| 1 | Medical Devices | pdf | Download | communication-to-industry position-statement | medical-devices |
| 2.32 | Wound Dressings | Communication to industry, Position statement | 2011 Nov
| 1 | Medical Devices | pdf | Download | communication-to-industry position-statement | medical-devices |
| 9.103 | Tissue Engineering Products | Communication to industry, Position statement | 2017 Nov
| 1 | Medical Devices | pdf | Download | communication-to-industry position-statement | medical-devices |
| 9.105 | Section 21 Authorisation of Sale Unregistered Medical Devices | Communication to industry, Position statement | 2017 Nov
| 1 | Emergency use, Medical Devices, Section 21, Unregistered products | pdf | Download | communication-to-industry position-statement | emergency-use medical-devices section-21 unregistered-products |
| 9.106 | Class A Medical Devices | Communication to industry, Position statement | 2017 Sep
| 1 | Medical Devices | pdf | Download | communication-to-industry position-statement | medical-devices |
| 9.78 | Disinfectants Status of Antiseptics and Germicides | Communication to industry, Position statement | 2016 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry position-statement | medical-devices |
| 9.79 | Medical Device Establishments: License Requirements | Communication to industry, Position statement | 2016 Sep
| 1 | Medical Devices | pdf | Download | communication-to-industry position-statement | medical-devices |
| 9.96 | Transitional Arrangements for Medical Devices | Communication to industry, Position statement | 2017 Apr
| 1 | Medical Devices | pdf | Download | communication-to-industry position-statement | medical-devices |
| 8.10 | FAQ: Licencing of medical device establishments | FAQ, Other documents | 2017 Nov
| 1 | Medical Devices | pdf | Download | faq other-documents | medical-devices |
| WHO Global Model Regulatory Framework for Medical Devices including IVD medical devices | Other documents, WHO document | 2017 Jan
| 1 | Medical Devices | www | Download | other-documents who-document | 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 |
| 2.48 | Veterinary Medicines Exemptions guidelines | Guideline | 2020 Mar
| 1 | Quality, Veterinary medicines | | Download | guideline | quality veterinary-medicines |
| SAHPGL-PEM-VET-02 | Veterinary Medicines Clinical Guideline | Guideline | 2022 Sept
| 2 | Quality, Veterinary medicines | pdf | Download | guideline | quality veterinary-medicines |
| Annual Report (2020/2021) | Annual Report | 2021 May
| 1 | Corporate | pdf | Download | annual-report | corporate |
| Annual Report (2019/2020) | Annual Report | 2020 May
| 1 | Corporate | pdf | Download | annual-report | corporate |
| Annual Report (2018/2019) | Annual Report | 2019 May
| 1 | Corporate | pdf | Download | annual-report | corporate |
| MD030 | Medical Device Establishment Licence Renewal – ISO13485 Certificate Communication | Communication to industry | 2022 Feb
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD031 | Medical Device Establishment Licence Renewal Process | Communication to industry | 2022 Sep
| 2 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 2.40 | Multiple submissions of the same application for registration with different proprietary names | Guideline | 2019 May
| 4 | General ECTD & human medicines | | Download | guideline | general-ectd-human-medicines-guidelines |
| HPA03 | Priority Review Requests Communication | Communication to industry | 2022 Feb
| 2 | General ECTD & human medicines | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
| REQUESTS: Existing Category D (Complementary Medicines) Registration Applications (07 October 2021) | Communication to industry | 2022 Feb
| 1 | Complementary Medicines | pdf | Download | communication-to-industry | complementary-medicines |
| 7.04 | Communication to industry – 7.04 Health Supplements Safety and Efficacy | Communication to industry | 2022 Mar
| 1 | Complementary Medicines | pdf | Download | communication-to-industry | complementary-medicines |
| Submission of Post-Importation Testing Exemption requests for Biological and Biosimilar Medicines | Communication to industry | 2022 Mar
| 1 | Biological Medicines Evaluation and Research, Inspectorate and good manufacturing practices | pdf | Download | communication-to-industry | biological-medicines-evaluation-and-research inspectorate-and-good-manufacturing-practices |
| Upcoming SAHPRA and Industry workshop | Communication to industry | 2022 Mar
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| Communication to Stakeholders with regards to the current status of the Medical Device Regulations | Communication to industry | 2022 Mar
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD032 | ISO 13485 Conformity Assessment Body Communication | Communication to industry | 2022 Aug
| 2 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD034 | Conditions for use of COVID-19 antigen self-test kits | Communication to industry | 2022 Mar
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| MD035 | Usability studies for Covid-19 self-testing kits requirements | Communication to industry | 2022 Mar
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| Conformity assessment body(cab) requirements for recognition by Sahpra checklist | Checklist, Communication to industry | 2022 Mar
| 1 | Medical Devices | pdf | Download | checklist communication-to-industry | medical-devices |
| Conformity of assessment body DoC template | Communication to industry, Templates | 2022 Mar
| 1 | Medical Devices | docx | Download | communication-to-industry templates | medical-devices |
| MD033 | Specification criteria for COVID-19 rapid antigen selftests | Communication to industry | 2022 Mar
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| SAHPGL-PEM-BIO-06 | General guidance document on QSE for Biological Medicines | Guideline | 2022 Aug
| 2 | Biological Medicines Evaluation and Research | pdf | Download | guideline | biological-medicines-evaluation-and-research |
| Cannabis and related substances | Newsletter | 2020 Feb
| 1 | Regulatory Compliance | pdf | Download | newsletter | regulatory-compliance |
| SAHPRA backlog clearance programme newsletter August 2020 | Newsletter | 2020 Aug
| 1 | Backlog | pdf | Download | newsletter | backlog |
| VigiGuardian Newsletter April 2022 | Newsletter | 2022 Apr
| 1 | pharmacovigilance | pdf | Download | newsletter | pharmacovigilance |
| SAHPGL-GOV-01 | Guideline for appeals against Regulatory decisions | Guideline | 2022 Apr
| 1 | Quality Management System | pdf | Download | guideline | quality-management-system |
| SAHPGL-CEM-PV-01 | Pharmacovigilance Inspections for Human Medicinal Products | Guideline | 2022 May
| 1 | pharmacovigilance | pdf | Download | guideline | pharmacovigilance |
| SAHPGL-CEM-PV-02 | Pharmacovigilance systems | Guideline | 2022 May
| 1 | pharmacovigilance | pdf | Download | guideline | pharmacovigilance |
| SAHPGL-CEM-NS-01 | Application for rescheduling of a substance or medicine | Guideline | 2022 May
| 1 | Names and Scheduling | pdf | Download | guideline | names-and-scheduling |
| Payment of annual retention fees for registered products | Communication to industry | 2022 May
| 1 | General ECTD & human medicines | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
| SAHPGL-PEM-BIO-01 | Guideline for Lot Release of Human Vaccines | Guideline | 2022 Sep
| 3 | Biological Medicines Evaluation and Research | pdf | Download | guideline | biological-medicines-evaluation-and-research |
| 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 |
| Communication to Industry – Applications for GMP and CPP Certificates | Communication to industry | 2022 Jun
| 1 | Inspectorate and good manufacturing practices | pdf | Download | communication-to-industry | inspectorate-and-good-manufacturing-practices |
| SAHPRA’s Vaccine Authorisation Process | Presentations | 2021 Sep
| 1 | Biological Medicines Evaluation and Research | pdf | Download | presentations | biological-medicines-evaluation-and-research |
| COVID-19 vaccines Regulatory Status Update | Presentations | 2021 Jan
| 1 | Biological Medicines Evaluation and Research | pdf | Download | presentations | biological-medicines-evaluation-and-research |
| Update on COVID-19 Diagnostic tests | Presentations | 2020 May
| 1 | Medical Devices | pdf | Download | presentations | medical-devices |
| PRESENTATION TO THE NCC- MINISTER OF HEALTH- 19 MAY 2020 | Presentations | 2020 May
| 1 | Corporate | pdf | Download | presentations | corporate |
| PARLIAMENTARY PORTFOLIO COMMITTEE ON HEALTH- COVID-19 | Presentations | 2020 Apr
| 1 | Corporate | pptx | Download | presentations | corporate |
| Cannabis and Related Substances Legislation and Regulation | Presentations | 2021 Mar
| 1 | Cannabis, Names and Scheduling, Regulatory Compliance | pdf | Download | presentations | cannabis names-and-scheduling regulatory-compliance |
| The Status of Cannabis for Medicinal and Research Purposes | Presentations | 2019 Oct
| 1 | Cannabis, Names and Scheduling, Regulatory Compliance | pdf | Download | presentations | cannabis names-and-scheduling regulatory-compliance |
| SA’s Covid-19 epidemic: Trends & Next steps | Presentations | 2020 Apr
| 1 | NDOH | pdf | Download | presentations | ndoh |
| SAHPRA’s Annual Performance Plan: 2019-2020 | Presentations | 2019 Sep
| 1 | Corporate | pdf | Download | presentations | corporate |
| Radiation Control | Presentations | 2019 Oct
| 1 | Radiation Control | pdf | Download | presentations | radiation-control |
| Cannabis presentation | Presentations | 2022 Jun
| 1 | Cannabis, Regulatory Compliance | pdf | Download | presentations | cannabis regulatory-compliance |
| GOV01_V01 | PAIA Manual | Policies | 2021 Apr
| 1 | Corporate | pdf | Download | policies | corporate |
| OF-GOV-01A | Request for access to record of held by SAHPRA (PAIA form) | Form | 2021 Apr
| 1 | Corporate | docx | Download | form | corporate |
| Retention Fee Notification – 9 June 2022 | Communication to industry | 2022 Jun
| 1 | Biological Medicines Evaluation and Research, General ECTD & human medicines, Inspectorate and good manufacturing practices, Medical Devices | pdf | Download | communication-to-industry | biological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines inspectorate-and-good-manufacturing-practices medical-devices |
| Communication on Medicines Registration Renewals Implementation Framework | Communication to industry | 2022 Nov
| 2 | Biological Medicines Evaluation and Research, General ECTD & human medicines, Quality, Veterinary medicines | pdf | Download | communication-to-industry | biological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines quality veterinary-medicines |
| SAHPGL-CEM-PV-04 | POST-MARKETING REPORTING OF ADVERSE DRUG REACTIONS TO HUMAN MEDICINES IN SOUTH AFRICA | Guideline | 2022 Jun
| 9 | pharmacovigilance | pdf | Download | guideline | pharmacovigilance |
| Summary of Medicines Safety Regulatory Decisions | Communication to industry | 2022 Jun
| 1 | pharmacovigilance | pdf | Download | communication-to-industry | pharmacovigilance |
| SAHPGL-INSP-RC-05 | Guidelines for Medicine Recalls – Withdrawals and Rapid Alerts | Guideline | 2022 Jun
| 3 | Regulatory Compliance | pdf | Download | guideline | regulatory-compliance |
| SAHPGL-INSP-RC-06 | Guideline to Fee Determination and Payments of Permits and Related Authorisations | Guideline | 2022 Jun
| 1 | Regulatory Compliance | pdf | Download | guideline | regulatory-compliance |
| SAHPGL-INSP-RC-07 | Guidelines for Advertisement of Medicines and Health Products | Guideline | 2022 Jun
| 2 | Regulatory Compliance | pdf | Download | guideline | regulatory-compliance |
| SAHPGL-INS-RC-11 | Guideline for Release of Import Health Products at Ports of Entry | Guideline | 2022 Jun
| 2 | Regulatory Compliance | pdf | Download | guideline | regulatory-compliance |
| SAHPGL-INS-RC-1 | Guidelines for Market Surveillance Of Medicines | Guideline | 2022 Jun
| 2 | Regulatory Compliance | pdf | Download | guideline | regulatory-compliance |
| Communication to Industry on Nitrosamine Review for New Applications and Registered Products including Biologicals | Communication to industry | 2022 Jun
| 1 | General ECTD & human medicines | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
| SAHPGL-HPA-04 | Renewal of Human and Veterinary Medicines Requirements and Process | Guideline | 2022 Jun
| 1 | General ECTD & human medicines, Veterinary medicines | pdf | Download | guideline | general-ectd-human-medicines-guidelines veterinary-medicines |
| SAHPGL-LIC-02 | Guideline on How to Apply for A Licence to Act as A Wholesaler | Guideline | 2022 Jun
| 2 | Licencing | pdf | Download | guideline | licencing |
| SAHPGL-LIC-03 | Guideline on How to Amend a Current Licence | Guideline | 2022 Jun
| 1 | Licencing | pdf | Download | guideline | licencing |
| Cannabis and related substances | FAQ | 2020 Jan
| 1 | Cannabis, Regulatory Compliance | pdf | Download | faq | cannabis regulatory-compliance |
| MD036 | COVID-19 Test Kits Batch Verification | Communication to industry | 2022 Jun
| 1 | Medical Devices | www | Download | communication-to-industry | medical-devices |
| Guideline on completion of the veterinary medicines clinical trial application form | Guideline | 2019 Sep
| 1 | Clinical Trials, Quality, Veterinary medicines | | Download | guideline | clinical-trials quality veterinary-medicines |
| SAHPGL-PEM-VET-01 | Guideline on application for use of unregistered veterinary medicines | Guideline | 2022 Aug
| 3 | Emergency use, Section 21, Unregistered products, Veterinary medicines | pdf | Download | guideline | emergency-use section-21 unregistered-products veterinary-medicines |
| SAHPGL-INSP-RC-13 | Guideline For Cultivation Of Cannabis | Guideline | 2022 Nov
| 3 | Cannabis, Licencing, Regulatory Compliance | pdf | Download | guideline | cannabis licencing regulatory-compliance |
| 40869 | Medicines And Related Substances Act, 1965 (Act no. 101 Of 1965) as amended | Act | 2017 May
| | Corporate | pdf | Download | act | corporate |
| 41064 | General Regulations | Regulation | 2017 Aug
| | Corporate | pdf | Download | regulation | corporate |
| No. 3834 | Hazardous Substances Act (Act No. 15 Of 1973) | Act | 2017 May
| 94 | Corporate | pdf | Download | act | corporate |
| No. 26595 | National Health Act, 2003 (Act No. 61 Of 2003) | Act | 2004 Jul
| 469 | Corporate | pdf | Download | act | corporate |
| No. 3751 | Fertilisers, farm feeds, agricultural remedies and stock remedies act, 1947 (act no. 36 of 1947) | Act | 1947 Jan
| CXLVII | Corporate | pdf | Download | act | corporate |
| No. 9152 | Animal Diseases Act, 1984 (Act No. 35 Of 1984) | Act | 1984 Apr
| 226 | Corporate | pdf | Download | act | corporate |
| No. 8051 | Veterinary And Para-veterinary Professions Act, 1982 (Act No. 19 Of 1982) | Act | 1982 Mar
| 201 | Corporate | pdf | Download | act | corporate |
| No. 14143 | Drugs And Drug Trafficking Act, 1992 (Act No. 140 Of 1992) | Act | 1992 Jul
| 329 | Corporate | pdf | Download | act | corporate |
| SAHPGL-RDN-RN-05 | Guideline On Afterloader Source Exchange Forms (RNXM) | Guideline | 2022 Jul
| 1 | Radiation Control, Radionuclides | pdf | Download | guideline | radiation-control radionuclides |
| The Innovation In Regulatory Sciences Capacity Development In Africa Meeting | Report | 2020 Jun
| 1 | Corporate | pdf | Download | report | corporate |
| SAHPRA Annual Performance Plan 2022 – 2023 | Planning document | 2022 Jun
| 1 | Corporate | pdf | Download | planning-document | corporate |
| SAHPRA Annual Performance Plan 2021 – 2022 | Planning document | 2021 Oct
| 1 | Corporate | pdf | Download | planning-document | corporate |
| SAHPRA Annual Performance Plan 2020 – 2021 | Planning document | 2020 Jun
| 1 | Corporate | pdf | Download | planning-document | corporate |
| Strategic Framework | Planning document | 2020 Jul
| 1 | Corporate | pdf | Download | planning-document | corporate |
| SAHPRA Strategic Plan 2020 and 2021 – 2024 and 2025 | Planning document | 2022 Jun
| 1 | Corporate | pdf | Download | planning-document | corporate |
| Expression Of Interest: SADC Medicines Regulatory Worksharing, Zazibona Collaborative Process | Communication to industry, Expression of interest | 2019 Oct
| 1 | General ECTD & human medicines | pdf | Download | communication-to-industry expression-of-interest | general-ectd-human-medicines-guidelines |
| VigiGuardian Newsletter July 2022 | Newsletter | 2022 Jul
| 1 | pharmacovigilance | pdf | Download | newsletter | pharmacovigilance |
| No. 3530 | Foodstuffs, Cosmetics And Disinfectants Act, 1972 (Act No. 54 Of 1972) As Amended | Act | 1972 Jun
| 84 | Corporate | pdf | Download | act | corporate |
| No. 19519 | Environmental Management Act: Waste Management Act, 1998 (Act No. 107 Of 1998) | Act | 1998 Nov
| 401 | Corporate | pdf | Download | act | corporate |
| Health Professions Act, 1974 (Act No. 56 Of 1974) | Act | 1975 Feb
| | Corporate | pdf | Download | act | corporate |
| No. 8883 | Nursing Act, 1978 (Act No. 50 Of 1978) | Act | 2006 May
| 491 | Corporate | pdf | Download | act | corporate |
| No. 4442 | Pharmacy Act, 1974 (Act No. 53 Of 1974) | Act | 1974 Oct
| 112 | Corporate | pdf | Download | act | corporate |
| No. 866 | Customs And Excise Act, 1964 (Act No. 91 Of 1964) | Act | 1964 Jul
| XIII | Corporate | pdf | Download | act | corporate |
| No. 18491 | Basic Conditions Of Employment Act, 75 Of 1997 | Act | 1997 Dec
| 390 | Corporate | pdf | Download | act | corporate |
| No. 20852 | Promotion Of Access To Information Act 2 Of 2000 | Act | 2000 Feb
| 416 | Corporate | pdf | Download | act | corporate |
| No. 20853 | Promotion Of Administrative Justice Act 3 Of 2000 | Act | 2000 Feb
| 316 | Corporate | pdf | Download | act | corporate |
| No. 25899 | Broad-based Black Economic Empowerment Act 2003 | Act | 2004 Jan
| 463 | Corporate | pdf | Download | act | corporate |
| No. 45673 | Published Gazette – Extension Notice (SECTION 18 OF ACT 101) | Government Gazette | 2021 Dec
| 678 | Corporate | pdf | Download | government-gazette | corporate |
| No. 43484 | Published Gazette – Alcohol based hand sanitiser 2020 | Government Gazette | 2020 Jun
| 721 | Corporate | pdf | Download | government-gazette | corporate |
| No. 43347 | Amendment To Schedules – CBD-containing Products 2020 | Government Gazette | 2020 May
| 659 | Corporate | pdf | Download | government-gazette | corporate |
| No. 41064 | General Regulations – Medicines And Related Substances Act, 1965 (25 August 2017) | Government Gazette, Regulation | 2017 Aug
| 859 | Corporate | pdf | Download | government-gazette regulation | corporate |
| No. 43346 | Exclusion Of Medicines, Medical Devices And (IVDs) Donated To The State | Government Gazette | 2020 May
| 659 | Corporate | pdf | Download | government-gazette | corporate |
| No. 44026 | Regulations Regarding Fees Payable In Terms Of The Provisions Of The Medicines And Related Substances Act, 1965 (Act No. 101 Of 1965) | Government Gazette | 2020 Dec
| 666 | Corporate | pdf | Download | government-gazette | corporate |
| NSTF-South 32 Awards 2021-2022 | Newsletter | 2022 Jul
| 1 | Corporate | pdf | Download | newsletter | corporate |
| Electronic Submission Of Adverse Drug Reaction (ADR) Reports – E2b Reporting | Communication to industry | 2022 Aug
| 1 | pharmacovigilance | pdf | Download | communication-to-industry | pharmacovigilance |
| SAHPRA Digital Transformation – Deployment of a Stakeholder portal | Communication to industry | 2022 Aug
| 1 | Corporate, Information Technology | pdf | Download | communication-to-industry | corporate information-technology |
| 2.21 | South African Specification for eCTD Regional Module1 | Guideline | 2019 May
| 3 | General ECTD & human medicines | | Download | guideline | general-ectd-human-medicines-guidelines |
| Medical Examinations For Radiation Workers | Guideline | 2009 Jul
| 2 | Radiation Control, Radionuclides | | Download | guideline | radiation-control radionuclides |
| SAHGPL-RDN-XR-19 | Guideline for Management of Pregnant Radiographers and Other Staff Members | Guideline | 2022 Sept
| 1 | Radiation Control, Radionuclides, x-rays | pdf | Download | guideline | radiation-control radionuclides x-rays |
| Internal rules – Minimum requirements | Guideline | 2009 Jul
| 2 | Radiation Control, Radionuclides | | Download | guideline | radiation-control radionuclides |
| SAHPGL-RDN-RN-10 | Leak tests | Guideline | 2022 Dec
| 3 | Radiation Control, Radionuclides | pdf | Download | guideline | radiation-control radionuclides |
| Licensing Requirements For New Nuclear Medicine Practices | Guideline | 2014 Sep
| 2 | Radiation Control, Radionuclides | | Download | guideline | radiation-control radionuclides |
| SAHPGL-RDN-RN-11 | RPO Competence and Training Requirements | Guideline | 2022 Dec
| 2 | Radiation Control, Radionuclides | pdf | Download | guideline | radiation-control radionuclides |
| Guidelines Regarding Organisational Requirements For Authority Holders And Their Appointed Radiation Protection Officers In Respect Of Group Iv Hazardous Substances | Guideline | 2009 Jul
| 2 | Radiation Control, Radionuclides | | Download | guideline | radiation-control radionuclides |
| Code of Practice – Safe use of soil moisture and density gauges | Guideline | 2019 Jul
| 5 | Radiation Control, Radionuclides | | Download | guideline | radiation-control radionuclides |
| SAHPGL-RDN-XR-15 | Guideline for Ionising Radiation Dose Limits and Annual Limits on Intake of Radioactive Material | Guideline | 2022 Aug
| 1 | Radiation Control, Radionuclides, x-rays | pdf | Download | guideline | radiation-control radionuclides x-rays |
| FIRE | Protective measures to take in the event of an accident involving radioactivity | Guideline | 2001 Feb
| 2 | Radiation Control, Radionuclides | | Download | guideline | radiation-control radionuclides |
| GAUGE | Code of Practice for the safe use of industrial gauges containing radioactive sources | Guideline | 2019 May
| 2 | Radiation Control, Radionuclides | | Download | guideline | radiation-control radionuclides |
| IRCP91-2 | Industrial radiography (gamma radiography) | Guideline | 2019 May
| 2 | Radiation Control, Radionuclides | | Download | guideline | radiation-control radionuclides |
| SAHPGL-RDN-RN-12 | Reporting National Radiation Occurrences | Guideline | 2022 Dec
| 2 | Radiation Control, Radionuclides | pdf | Download | guideline | radiation-control radionuclides |
| SAHPGL-RDN-RN-09 | I-131 Therapy | Guideline | 2022 Dec
| 2 | Radiation Control, Radionuclides | pdf | Download | guideline | radiation-control radionuclides |
| RN-REQ-SRC-001 | Label sources & containers | Guideline | 2014 Jul
| 1 | Radiation Control, Radionuclides | | Download | guideline | radiation-control radionuclides |
| TRUG91-1 | Safe transport of radioactive material | Guideline | 2005 May
| 2 | Radiation Control, Radionuclides | | Download | guideline | radiation-control radionuclides |
| UNSEAL | Safe use of unsealed radioactive nuclides | Guideline | 2001 Feb
| 2 | Radiation Control, Radionuclides | | Download | guideline | radiation-control radionuclides |
| SAHPGL-RDN-RN-13 | Management and Disposal of Non-nuclear Radioactive Waste | Guideline | 2022 Dec
| 2 | Radiation Control, Radionuclides | pdf | Download | guideline | radiation-control radionuclides |
| SAHPGL-RDN-XR-21 | Guideline for Patient Dose Measurements in Diagnostic Radiology | Guideline | 2022 Sept
| 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-22 | Guideline for Protective Clothing | Guideline | 2022 Sept
| 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-20 | Guideline for Use of Radiographic Grid Ratio | Guideline | 2022 Sept
| 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-10 | Guideline For Radiation Monitoring Requirements And Radiation Occurrences | Guideline | 2022 Aug
| 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-18 | Guidelines on Requests for Medical X-Ray Examinations | Guideline | 2022 Sept
| 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-14 | Guideline of Test Procedures for Film Processing and Intensifying Screens | Guideline | 2022 Aug
| 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-01 | Guideline for QC in Medical Diagnostic X-Ray Imaging Systems | Guideline | 2022 Aug
| 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-13 | Guideline for QC in Dental Diagnostic X-Ray Imaging Systems | Guideline | 2022 Aug
| 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-08 | Guideline for Personal Monitoring Med and Vet Use of Diagnostic X-Ray Equipment | Guideline | 2022 Aug
| 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-05 | General Guideline For Cabinet And Conveyer Belt X-ray | Guideline | 2022 Aug
| 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-11 | General Guidelines with Regards to the Design of X-Ray Rooms | Guideline | 2022 Aug
| 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-02 | Guideline For Code Of Practice For Users Of Medical Xray Equipment | Guideline | 2022 Aug
| 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-06 | Guideline For Reducing Radiation Risk From Computer Tomography For Pediatric And Small Adult Patients | Guideline | 2022 Aug
| 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-04 | Guideline for Minimum Requirements For Fixed Diagnostic X-Ray Installations | Guideline | 2022 Aug
| 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-12 | Guideline for Monitoring of Radiation workers in a Theatre | Guideline | 2022 Aug
| 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-07 | Guideline for Bone Densitometer – Operators | Guideline | 2022 Aug
| 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-16 | Guideline for Code of Practise for Industrial Radiography X-Ray | Guideline | 2022 Aug
| 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-09 | Guideline For Code Of Practice For Users Of Non – Medical X-RAY Equipment – Forensic | Guideline | 2022 Aug
| 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-23 | Guideline Radiologist Available by Remote Digital Connection | Guideline | 2022 Sept
| 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| SAHPGL-RDN-XR-03 | Guideline for Dental Radiography | Guideline | 2022 Aug
| 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| DHCPL | Topical Corticosteroid – Risk of Withdrawal Reactions – Aspen | Communication To Health Care Professionals | 2022 Aug
| 2 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | VSIQQ® (Brolucizumab) – A Requirement to Discontinue Treatment with Vsiqq® in Patients who Develop Retinal Vasculitis and/or Retinal Vascular Occlusion, Typically in the Presence of Intraocular Inflammation | Communication To Health Care Professionals | 2021 Nov
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | COMIRNATY® (COVID-19 mRNA Vaccine) -Warning regarding rare cases of Myocarditis and Pericarditis | Communication To Health Care Professionals | 2021 Aug
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | SAHPRA Statement on Adverse Events Following Immunisation (AEFIs) with COVID 19 Vaccines | Communication To Health Care Professionals | 2021 Aug
| 1 | pharmacovigilance | www | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | COVID-19 Vaccine Janssen | Communication To Health Care Professionals | 2021 Jul
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | Selective Serotonin Reuptake Inhibitors (SSRIS) and Serotonin–Norepinephrine Reuptake Inhibitors (SNRIS) associated with the risk of Postpartum Haemorrhage | Communication To Health Care Professionals | 2021 Jun
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | Dopaminergic Medicines used in the treatment of Parkinson’s Disease: Risk of Dopamine Dysregulation Syndrome | Communication To Health Care Professionals | 2021 May
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | COVID-19 Vaccine Janssen: Risk of Thrombosis in combination with Thrombocytopenia | Communication To Health Care Professionals | 2021 Nov
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | SAHPRA launches the Med Safety App for self-reporting of suspected Adverse Drug Reactions by the Public and Healthcare Professionals | Communication To Health Care Professionals | 2021 Apr
| 1 | pharmacovigilance | www | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | Risk Of Drug Induced Liver Injury Associated With The Use Of Metamizole-containing Medicines | Communication To Health Care Professionals | 2021 Mar
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | Increased Risk Of Subclinical Acute Interstitial Nephritis Associated With The Use Of Proton Pump Inhibitors (Ppis) Leading To Acute Kidney Injury And/or Chronic Renal Failure | Communication To Health Care Professionals | 2021 Feb
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | Eltroxin New Formulation (25 Mcg, 50 Mcg, 75 Mcg, 100 And 200 Mcg Tablets: Increased Adverse Events Reports And Requirement For Patient Therapeutic Monitoring By Healthcare Professionals. | Communication To Health Care Professionals | 2020 Dec
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | Diphenhydramine-containing Medicines | Communication To Health Care Professionals | 2020 Nov
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | Dopaminergic medicines used in the treatment of parkinson’s disease: Risk of Dopamine dysregulation syndrome | Communication To Health Care Professionals | 2020 Oct
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | Tecentriq® (atezolizumab): Risk of Severe Cutaneous Adverse Reactions (SCARs) and Immune-related myositis | Communication To Health Care Professionals | 2020 Nov
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | Risk of dopamine dysregulation syndrome (DDS) associated with the use of dopaminergic medicines used for the treatment of Parkinson’s disease (PD). | Communication To Health Care Professionals | 2021 Nov
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | Fluoropyrimidine containing medicines and related substances: Increased drug exposure and toxicity in patients with dihydropyrimidine dehydrogenase (DPD) deficiency | Communication To Health Care Professionals | 2020 Oct
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | Tyrosine kinase inhibitors | Communication To Health Care Professionals | 2020 Jun
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | Ondansetron: Warning about small increased risk of oral clefts following use in the first 12 weeks of pregnancy | Communication To Health Care Professionals | 2020 Jun
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | Sandoz and Novartis: Warning about small increased risk of oral clefts following use in the first 12 weeks of pregnancy | Communication To Health Care Professionals | 2020 Jun
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | Fluoroquinolones: risk of mitral and aortic regurgitation associated with the use of oral and injectable fluoroquinolones | Communication To Health Care Professionals | 2020 Jun
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | DHCPL for ACE-inhibitor/Angiotensin receptor blocker containing medicines | Communication To Health Care Professionals | 2019 Oct
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | Increased risk of thrombo-embolic events in patients with anti-phopholipid syndrome (APS) treated with Eliquis | Communication To Health Care Professionals | 2019 Sep
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | Increased risk of thrombo-embolic events in patients with anti-phopholipid syndrome (APS) treated with Xarelto | Communication To Health Care Professionals | 2019 Aug
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | Increased risk of thrombo-embolic events in patients with anti-phopholipid syndrome (APS) treated with Pradaxa | Communication To Health Care Professionals | 2019 Aug
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | Risk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers – 1 August 2019 | Communication To Health Care Professionals | 2019 Aug
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | Risk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers | Communication To Health Care Professionals | 2019 Aug
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | Risk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers | Communication To Health Care Professionals | 2019 Jul
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | Risk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers | Communication To Health Care Professionals | 2019 Jun
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | Risk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers | Communication To Health Care Professionals | 2019 Jun
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | Dolutegravir – Risk of neural tube defects | Communication To Health Care Professionals | 2019 Apr
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | Gadolinium-Based Contrast Agents – Deposition in the brain | Communication To Health Care Professionals | 2019 Apr
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | EPOETIN ALFA – New warnings on severe cutaneous adverse reaction | Communication To Health Care Professionals | 2019 Apr
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | Amphotericin B – Risk of Medication Error | Communication To Health Care Professionals | 2019 Apr
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | Hyoscine Butylbromide – Risk of adverse effects in patients with underlying cardiac disease | Communication To Health Care Professionals | 2019 Apr
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | Lamotrigine – Risk of Hemophagocytic Lymphohistiocytosis | Communication To Health Care Professionals | 2019 Apr
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | Hydrochlorothiazide – Risk of non-menoloma skin cancer | Communication To Health Care Professionals | 2019 Apr
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | Clozapine – Induced gastrointestinal hypomotility | Communication To Health Care Professionals | 2019 Apr
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | Valproate containing medicines – High risk of congenital abnormalities and development disorders | Communication To Health Care Professionals | 2019 Apr
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | Cefepime hydrochloride – Risk of serious adverse reactions | Communication To Health Care Professionals | 2019 Apr
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| DHCPL | Anagrelide hydrochloride: Risk of thrombosis including cerebral infarction upon abrupt treatment discontinuation | Communication To Health Care Professionals | 2022 Aug
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| GLF-CEM-PV-06A | Adverse Drug Reactions and Quality Problem Reporting Form | Form | 2022 Aug
| 1 | pharmacovigilance | pdf | Download | form | pharmacovigilance |
| Missing Applications – Call to Industry | Communication to industry | 2022 Aug
| 1 | Corporate, General ECTD & human medicines, Information Technology | pdf | Download | communication-to-industry | corporate general-ectd-human-medicines-guidelines information-technology |
| MD037 | Withdrawal of Section 21 Authorisation for use of unregistered rapidly developed non-invasive ventilators | Communication to industry | 2022 Jul
| 1 | Medical Devices | pdf | Download | communication-to-industry | medical-devices |
| 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 |
| Veterinary Clinical Trial Application Template | Templates | 2019 Dec
| 2 | Clinical Trials, Veterinary medicines | | Download | templates | clinical-trials veterinary-medicines |
| Owner Consent Form | Application forms, Form | 2019 Jul
| 2 | Veterinary medicines | | Download | application-forms form | veterinary-medicines |
| SAHPGL-RDN-XR-17 | Guideline for Disposal of X-Ray Units and Tubes Containing Beryllium | Guideline | 2022 Aug
| 1 | Radiation Control, x-rays | pdf | Download | guideline | radiation-control x-rays |
| 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 |
| Extension on commentary period for Borderline Products Guideline | Communication to industry | 2022 Sep
| 1 | Corporate, General ECTD & human medicines | pdf | Download | communication-to-industry | corporate general-ectd-human-medicines-guidelines |
| Over-arching: Good Review Practice Guide | Communication to industry, Guide | 2022 Jun
| 1 | Corporate, General ECTD & human medicines | pdf | Download | communication-to-industry guide | corporate 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 |
| GLF-PEM-VET-04A | Residue Overall Summary (ROS) | Templates | 2022 Sept
| 1 | Veterinary medicines | docx | Download | templates | veterinary-medicines |
| OF-PEM-VET-04A | Bioequivalence Trial Information for Veterinary Medicines | Form | 2022 Sept
| 1 | Veterinary medicines | docx | Download | form | veterinary-medicines |
| No. 46789 | Medicines and Related Substances Act Schedules | Government Gazette | 2022 Aug
| | Corporate | pdf | Download | government-gazette | corporate |
| SAHPP-QA-01 | Quality Policy Statement | Policies | 2021 Feb
| 1 | Quality Management System | pdf | Download | policies | quality-management-system |
| Annual Report (2021/2022) | Annual Report | 2022 Sep
| 1 | Corporate | www | Download | annual-report | corporate |
| Position Paper – Proposal to Applicants for Dossier Processing Fee (ZaZiBoNa) | Communication to industry | 2022 Oct
| 1 | General ECTD & human medicines | docx | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
| HPA07 | Certification Variation Screening – Type II Proprietary name change applications and TOA’s | Communication to industry | 2022 Oct
| 1 | General ECTD & human medicines | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
| GLF-PEM-02B | Template of Standardised Content of Letter of Access | Templates | 2022 Oct
| 1 | General ECTD & human medicines | docx | Download | templates | general-ectd-human-medicines-guidelines |
| GLF-PEM-02A | Submission Form | Form | 2022 Oct
| 1 | General ECTD & human medicines | docx | Download | form | general-ectd-human-medicines-guidelines |
| DHCPL | Topical corticosteroids – DHCPL – Risk of withdrawal reactions | Communication To Health Care Professionals | 2022 Oct
| 1 | pharmacovigilance | pdf | Download | communication-to-health-care-professionals | pharmacovigilance |
| South African Regulatory Authority: The Impact of Reliance on the Review Process Leading to Improved Patient Access | Published papers | 2021 Jul
| 1 | | pdf | Download | published-papers | |
| Common deficiencies found in generic FPP applications submitted for registration to SAHPRA | Published papers | 2021 Dec
| 1 | | pdf | Download | published-papers | |
| Bioequivalence Common Deficiencies in Generic Products Submitted for Registration to SAHPRA | Published papers | 2022 Jun
| 1 | | pdf | Download | published-papers | |
| Common deficiencies found in API section of Non-Sterile Generic Products submitted for registration to SAHPRA | Published papers | 2021 Dec
| 1 | | pdf | Download | published-papers | |
| Clinical Trials Committee And Submission Dates For 2023 | Communication to industry | 2022 Oct
| 1 | Clinical Evaluations Management, Clinical Trials | pdf | Download | communication-to-industry | clinical-evaluations-management clinical-trials |
| Renewals Frequently Asked Questions (FAQs) | Communication to industry, FAQ | 2022 Nov
| 1 | Biological Medicines Evaluation and Research, General ECTD & human medicines, Quality, Veterinary medicines | pdf | Download | communication-to-industry faq | biological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines quality veterinary-medicines |
| SAHPGL-CEM-PV-03 | Risk Management Plans for Medicines for Human Use | Guideline | 2022 Sep
| 1 | pharmacovigilance | pdf | Download | guideline | pharmacovigilance |
| 8.06 | Guideline For Access To And Control Of Medical Devices And IVDs | Guideline | 2017 Apr
| 1 | Medical Devices | | Download | guideline | medical-devices |
| 8.01 | General Information Medical Devices And IVDs | Guideline | 2014 Aug
| 1 | Medical Devices | | Download | guideline | medical-devices |
| Expression of Interest-WHO Pre-Qualification Collaborative Registration Procedure | Communication to industry | 2022 Nov
| 1 | General ECTD & human medicines | pdf | Download | communication-to-industry | 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 |
| Certification Variation Screening – Type II Proprietary Name Change Applications and TOAs | Communication to industry | 2022 Dec
| 2 | General ECTD & human medicines | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines |
| HPA09 | Pre-registration veterinary medicines tracker guide | Communication to industry | 2022 Dec
| 1 | General ECTD & human medicines, Veterinary medicines | pdf | Download | communication-to-industry | general-ectd-human-medicines-guidelines veterinary-medicines |
| OF-QA-09A | Guidelines Comments Form | Form | 2023 Jan
| 2 | Quality Management System | doc | Download | form | quality-management-system |
