e-Library

Welcome to SAHPRA’s E-Library where you can browse and search for relevant documentation.

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Document NumberTitleCategoriesDate updatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
6.21Licence Application Medical Device Manufacture,

2016 Jul

1Downloadapplication-forms formmedical-devices
8.02Medical Device IVD Essential Principles

2019 Nov

2Downloadguidelinemedical-devices
6.12Complementary Medicines Section 21 Application Form

2013 Jul

1, Downloadapplication-formscomplementary-medicines section-21
7.01Complementary Medicines – Discipline Specific Safety and efficacy

2020 Jan

3pdfDownloadguidelinecomplementary-medicines
9.126Reflection document on regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2

2021 May

1Downloadguidelinebiological-medicines-evaluation-and-research
SAHPGL-CEM-NS-03Guideline for proprietary names for medicines

2022 May

7pdfDownloadguidelinenames-and-scheduling
2.30Biosimilar Medicines Guidance

2014 Aug

3Downloadguidelinebiological-medicines-evaluation-and-research
SAHPGL-CEM-NS-02Guideline to the scheduling of substances and medicines

2022 May

3pdfDownloadguidelinenames-and-scheduling
SAHPGL-CEM-NS-04Scheduling of substances for prescribing by authorised prescribers other than medical practitioners or dentists

2022 May

3pdfDownloadguidelinenames-and-scheduling
SAHPGL-PEM-BIO-03Guideline for Pre-Registration Consultation Meeting

2022 Sep

2pdfDownloadguidelinebiological-medicines-evaluation-and-research
SAHPGL-PEM-BIO-04Biological medicines stability Guideline

2022 Aug

2pdfDownloadguidelinebiological-medicines-evaluation-and-research
SAHPGL-PEM-BIO-05Biological Medicines Amendment guideline

2022 Sep

5pdfDownloadguidelinebiological-medicines-evaluation-and-research
6.20Pre-Registration Consultation Meeting Material Checklist

2014 Jun

1Downloadguidelinebiological-medicines-evaluation-and-research
Industry Communication on Interim Measures Pending Update of Variation Addendum,

2020 Sep

1pdfDownloadcommunication-to-industry guidelinegeneral-ectd-human-medicines-guidelines
2.01General information guideline

2019 Jul

10Downloadguidelinegeneral-ectd-human-medicines-guidelines
2.02Quality and Bioequivalence

2019 Jul

7Downloadguidelinegeneral-ectd-human-medicines-guidelines
SAHPGL-HPA-06Variations Addendum For Human And Veterinary Medicines

2022 Sep

6, pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines veterinary-medicines
SAHPGL-CEM-01Clinical guideline

2022 Aug

3, pdfDownloadguidelineclinical-evaluations-management general-ectd-human-medicines-guidelines
2.14Guideline for Patient Information Leaflet for Human Medicines

2019 Jul

2, , Downloadguidelineclinical-evaluations-management general-ectd-human-medicines-guidelines health-products-authorisation
SAHPGL-CEM-02Guideline for Professional Information for Human Medicines (Categories A and D)

2022 Sept

5, , pdfDownloadguidelineclinical-evaluations-management general-ectd-human-medicines-guidelines health-products-authorisation
2.22eCTD Validation Criteria

2016 Sep

2Downloadguidelinegeneral-ectd-human-medicines-guidelines
2.23Guideline for submission in eCTD format

2019 Jul

3Downloadguidelinegeneral-ectd-human-medicines-guidelines
2.58Submission in eSubmission format

2019 Jul

1Downloadguidelinegeneral-ectd-human-medicines-guidelines
2.59Guideline for the APIMF Procedure

2021 Jan

2, , Downloadguidelineclinical-evaluations-management general-ectd-human-medicines-guidelines pre-reg
SAHPGL-PEM-01Availability of medicines for use in a Public Health Emergency (PHE)

2022 Jun

2, , , pdfDownloadguidelineemergency-use general-ectd-human-medicines-guidelines section-21 unregistered-products
SAHPGL-INSP-02Guideline for Good Manufacturing Practice

2022 Sep

8, , pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines inspectorate-and-good-manufacturing-practices licencing
5.08Reliance Guideline

2022 Mar

3Downloadguidelinegeneral-ectd-human-medicines-guidelines
SAHPGL-HPA-05BAU Variations Communication,

2022 Sep

4pdfDownloadcommunication-to-industry guidelinegeneral-ectd-human-medicines-guidelines
9.127eCTD Implementation roadmap communication

2021 Oct

2Downloadguidelinegeneral-ectd-human-medicines-guidelines
9.128Pilot: BAU new medicine applications for registration

2021 Jul

2Downloadguidelinegeneral-ectd-human-medicines-guidelines
9.129Re-submission of BAU New Medicines Applications from 2018 and 2019

2021 Oct

2Downloadguidelinegeneral-ectd-human-medicines-guidelines
7.02Roadmap for CMs

2021 Dec

2pdfDownloadguidelinecomplementary-medicines
7.03Complementary Medicines – Use of the ZA-CTD format in the preparation of registration applications

2020 Jun

3pdfDownloadguidelinecomplementary-medicines
7.04Complementary Medicines – Health Supplements Safety and Efficacy

2022 Mar

4pdfDownloadguidelinecomplementary-medicines
7.05Complementary Medicines Registration Application ZA-CTD-Quality

2020 Jun

2pdfDownloadguidelinecomplementary-medicines
7.06CMs Specified Substances

2022 Jan

3pdfDownloadguidelinecomplementary-medicines
5.08Revised Guideline – DONATION OF MEDICINES MEDICAL DEVICES AND IVDs,

2020 Apr

3Downloadcommunication-to-industry guidelinemedical-devices
8.04Recalls Vigilance Medical Devices IVDs

2019 Nov

3Downloadguidelinemedical-devices
8.05CLASSIFICATION of MEDICAL DEVICES and IVDs

2021 Aug

5Downloadguidelinemedical-devices
8.07Medical Device Quality Manual

2019 Nov

2Downloadguidelinemedical-devices
MD004Extension – Use of acknowledgement letter in lieu of a licence,

2020 Mar

1pdfDownloadcommunication-to-industry guidelinemedical-devices
MD010Guidance Rapidly developed ventilator,

2020 May

1pdfDownloadcommunication-to-industry guidelinemedical-devices
16.03Licence Medical Devices IVDs

2019 Nov

3Downloadguidelinemedical-devices
Section 21 Access to Unregistered Medicines – IVERMECTIN CONTROLLED COMPASSIONATE USE PROGRAMME,

2022 May

2, , wwwDownloadcommunication-to-industry guidelineemergency-use section-21 unregistered-products
SAHPGL-CEM-S21-02Guideline For Section 21 Access To Unregistered Medicines

2022 Aug

4, , pdfDownloadguidelineemergency-use section-21 unregistered-products
SAHPGL-INSP-01Guideline for Post Importation Testing

2022 Sep

5pdfDownloadguidelineinspectorate-and-good-manufacturing-practices
SAHPGL-INSP-03Guideline for Good Wholesaling Practice for Wholesaler

2022 Sep

5, pdfDownloadguidelineinspectorate-and-good-manufacturing-practices licencing
SAHPGL-INSP-04Guideline for preparation of site master file

2022 Sep

5, pdfDownloadguidelineinspectorate-and-good-manufacturing-practices licencing
SAHPGL-INSP-05Guideline on how to respond to a GMP, GWP, GCP and GVP Inspection report

2022 Sep

2pdfDownloadguidelineinspectorate-and-good-manufacturing-practices
SAHPGL-INSP-06Guideline for Fee determination and Payment of GxP and Product related Inspection

2022 Sep

2pdfDownloadguidelineinspectorate-and-good-manufacturing-practices
SAHPGL-LIC-01Licence to Manufacture, Import or Export

2022 Jun

3pdfDownloadguidelinelicencing
SAHPGL-INSP-RC-02Guideline for the Importation and Exportation of Medicines

2022 Jun

2pdfDownloadguidelineregulatory-compliance
5.09Guideline On How To Lodge A Complaint On Medicines And Medical Devices

2021 Sep

2Downloadguidelineregulatory-compliance
SAHPGL-CEM-PV-06Guideline For Adverse Drug Reactions (ADRs) Reporting for Healthcare Professionals

2022 Aug

3pdfDownloadguidelinepharmacovigilance
GLF-CEM-PV-S01Valproate Annual Risk Acknowledgement Form

2022 Aug

1pdfDownloadformpharmacovigilance
SAHPGL-CEM-PV-05Guideline for the handling of Dear Healthcare Professional Letters relating to medicine safety

2022 Aug

6pdfDownloadguidelinepharmacovigilance
SA GCP Guidelines

2020 Jun

3Downloadguidelineclinical-trials
Clinical Trials Committee and Submission dates for 2022

2021 Jun

1pdfDownloadcommunication-to-industryclinical-trials
2.11Safety Reporting During Clinical Trials

2021 Aug

4Downloadguidelineclinical-trials
SAHPGL-CEM-CT-03Emergency Procedures for Clinical Trial Sites

2022 Aug

3pdfDownloadguidelineclinical-trials
SAHPGL-CEM-CT-07Post Clinical Trial Access

2022 Aug

4pdfDownloadguidelineclinical-trials
SAHPGL-CEM-CT-04Oversight and Monitoring in Clinical Trials

2022 Aug

4pdfDownloadguidelineclinical-trials
2.49Capacity Building and Transformation during Clinical Trials

2019 Jul

1Downloadguidelineclinical-trials
SAHPGL-CEM-CT-02Clinical Trial Participant Time, Inconvenience and Expense (TIE) Compensation Model

2022 Jul

2pdfDownloadguidelineclinical-trials
SAHPGL-CEM-CT-05Liability Insurance for Clinical Trials

2022 Aug

3pdfDownloadguidelineclinical-trials
SAHPGL-CEM-CT-06Procedure for Consultation Meetings with Clinical Trial Applicants

2022 Aug

2pdfDownloadguidelineclinical-trials
SAHPGL-CEM-CT-01Guideline For Electronic Submission of Clinical Trial Documents (Amendments, Bioequivalence Studies, Responses, Notifications, And Serious Adverse Events),

2022 Sept

3pdfDownloadcommunication-to-industry guidelineclinical-trials
9.84Clinical Trial Investigators,

2019 May

2Downloadcommunication-to-industry guidelineclinical-trials
17.05SAHPRA Payment Guideline

2022 Sept

7pdfDownloadguidelinefinance
SAHPRA INVOLVEMENT IN THE SWISSMEDIC MARKETING AUTHORISATION FOR GLOBAL HEALTH PRODUCTS (MAGHP) PROCEDURE

2021 Nov

1pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
2.17Communication to industry on the sartans-containing medicines

2020 Oct

2pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
2.18Communication to industry on ranitidine-containing medicines

2020 Oct

1pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
2.19Communication to industry on metformin-containing medicines

2020 Oct

1pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
Communication to industry on Clones and Replicas

2020 Nov

1pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
7.02updated – Roadmap and transitional process for the Regulation of complementary medicines

2021 Dec

1pdfDownloadcommunication-to-industrycomplementary-medicines
Application for a certificate of free sale for Category D medicines (Complementary Medicines)

2021 Nov

1pdfDownloadcommunication-to-industrycomplementary-medicines
Review of detained product at a port of entry as a Category D medicine

2021 Oct

1pdfDownloadcommunication-to-industrycomplementary-medicines
REQUESTS: Existing Category D (Complementary Medicines) Registration Applications – COMPLEMENTARY MEDICINES APPLICATIONS SUBMITTED FOR REGISTRATION

2021 Oct

1pdfDownloadcommunication-to-industrycomplementary-medicines
Communication to Stakeholders: Licensing of Complementary Medicines Manufacturers, Wholesalers, Distributors, Importers and Exporters

2020 Feb

1pdfDownloadcommunication-to-industrycomplementary-medicines
MD001Regulatory Requirements for Medical Devices COVID-19

2020 Jul

2pdfDownloadcommunication-to-industrymedical-devices
MD002Regulatory Requirements for Serological Test Kits

2020 Jul

2pdfDownloadcommunication-to-industrymedical-devices
MD003Testing for COVID-19

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
MD005Expedited Regulatory Pathways for Medical Devices

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
MD006Laboratory Testing and Use of COVID-19 Serological Test Kits

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
MD007Specifications Serological Test kits

2020 Jul

2pdfDownloadcommunication-to-industrymedical-devices
MD008ISO Standards for Medical Devices and Protective Clothing

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
MD009Alternative Regulatory Licensing Requirements Alcohol-based sanitisers

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
MD011Licence Conditions for COVID-19 Serological Test Kits

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
MD012Notice of Contravention of Act 101 of 1965

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
MD013Process Flow Locally Manufactured COVID-19 Test Kits

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
MD014Regulatory Requirements for Molecular Test Kits

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
MD015Process Flow Imported COVID-19 Test Kits

2022 Mar

2pdfDownloadcommunication-to-industrymedical-devices
MD016Conditions of Use COVID-19 Serological Test Kits

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
MD017Technical Review Application COVID-19 Molecular Test

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
MD018Specifications Molecular Test kits

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
MD019Processing of licence applications

2020 Jul

1pdfDownloadcommunication-to-industrymedical-devices
MD020Certificate of Free Sale

2020 Jul

2pdfDownloadcommunication-to-industrymedical-devices
MD021Use SARS CoV-2 Antibody Tests NDOH

2020 Aug

1pdfDownloadcommunication-to-industrymedical-devices
MD022Application Clinical Evaluation Medical Device IVD

2020 Aug

1pdfDownloadcommunication-to-industrymedical-devices
MD024Frequently asked questions: Performance evaluation of point-of-care COVID-19 serology antibody test kits

2020 Sep

1pdfDownloadcommunication-to-industrymedical-devices
MD025Licensing and Regulatory requirements for the manufacture and distribution of medical and respirator masks during Covid-19

2020 Sep

1pdfDownloadcommunication-to-industrymedical-devices
MD025Alternative licensing and regulatory pathway for masks

2020 Sep

1pdfDownloadcommunication-to-industrymedical-devices
MD027Section 21 Authorisation for the Importation of Research Use Only (RUO) In Vitro Diagnostic Devices (IVDs)

2021 Mar

1docxDownloadcommunication-to-industrymedical-devices
MD028Communication Retention Fees

2021 May

1pdfDownloadcommunication-to-industrymedical-devices
MD029Renewal of Section 21 Authorisation for use of unregistered rapidly developed non-invasive ventilators

2021 Jun

1pdfDownloadcommunication-to-industrymedical-devices
8.04Contact details for Guideline 8.04 Recall, Adverse Event And Post- Marketing Vigilance Reporting Of Medical Devices And IVDs

2021 Dec

1pdfDownloadcommunication-to-industrymedical-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)

2021 Mar

1, pdfDownloadcommunication-to-industryinspectorate-and-good-manufacturing-practices licencing
SAHPRA survey to determine company turnover

2021 Mar

1, pdfDownloadcommunication-to-industryinspectorate-and-good-manufacturing-practices licencing
Communication to industry on Post Marketing Reporting of ADRs guideline

2021 May

1pdfDownloadcommunication-to-industrypharmacovigilance
A SIGNAL OF MYOCARDITIS / PERICARDITIS ASSOCIATED WITH PFIZER-BIONTECH’S COVID-19 VACCINE, COMIRNATY (BNT162B2)

2021 Aug

1pdfDownloadsafety-alertspharmacovigilance
DIPHENHYDRAMINE-CONTAINING MEDICINES

2020 Nov

1pdfDownloadsafety-alertspharmacovigilance
21.8Communication to industry on ranitidine-containing medicines,

2020 Oct

1Downloadcommunication-to-industry safety-alertspharmacovigilance
21.9Communication to industry on metformin-containing medicines,

2020 Oct

1Downloadcommunication-to-industry safety-alertspharmacovigilance
21.5MSA gamma benzine hexachloride

2012 Jun

1pdfDownloadsafety-alertspharmacovigilance
21.6MSA cough and cold medicines

2012 Jun

1pdfDownloadsafety-alertspharmacovigilance
21.4MSA atypical antipsychotics

2009 Jun

2pdfDownloadsafety-alertspharmacovigilance
21.2MSA promethazine

2007 Sep

1pdfDownloadsafety-alertspharmacovigilance
21.3MSA Rotarix

2008 Mar

1pdfDownloadsafety-alertspharmacovigilance
21.1MSA ketoconazole and domperidone

2006 Jul

1pdfDownloadsafety-alertspharmacovigilance
OF-HPA-06ASAHPRA PRE-SUBMISSION MEETING REQUEST FORM

2021 Aug

2docxDownloadformgeneral-ectd-human-medicines-guidelines
Notification Template 1 for Nitrosamine Risk Evaluation

2021 Dec

1Downloadtemplatesgeneral-ectd-human-medicines-guidelines
Notification Template 2 for Nitrosamine Confirmatory Testing

2021 Dec

1Downloadtemplatesgeneral-ectd-human-medicines-guidelines
Outcome of Risk for Nitrosamine Investigation

2021 Dec

1Downloadtemplatesgeneral-ectd-human-medicines-guidelines
SAHPRA Variation Validation Template for eCTD

2020 Feb

1Downloadtemplatesgeneral-ectd-human-medicines-guidelines
SAHPRA Variation Validation Template for eSubmission

2020 Feb

1Downloadtemplatesgeneral-ectd-human-medicines-guidelines
6.16New Registration Validation Template for eCTD

2019 Jul

3Downloadtemplatesgeneral-ectd-human-medicines-guidelines
6.30New Registration Validation Template for eSubmission

2019 Jul

1Downloadtemplatesgeneral-ectd-human-medicines-guidelines
6.31Summary of Critical Regulatory Elements (SCoRE)

2020 Nov

3Downloadtemplatesgeneral-ectd-human-medicines-guidelines
OF-PEM-PRE-01JBioequivalence Trial Information Form (BTIF),

2022 Aug

4, docxDownloadform templatesgeneral-ectd-human-medicines-guidelines pharmaceutical-evaluation-management
6.33Abridged review template

2019 Aug

2Downloadtemplatesgeneral-ectd-human-medicines-guidelines
6.34Verified review template

2019 Aug

2Downloadtemplatesgeneral-ectd-human-medicines-guidelines
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
6.18Validation template CM

2020 Jun

2Downloadtemplatescomplementary-medicines
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
Communication to Industry Licence Acknowledgement Letter,

2019 Nov

1pdfDownloadcommunication-to-industry position-statementmedical-devices
Communication to Industry Licence Amendment,

2019 Nov

1pdfDownloadcommunication-to-industry position-statementmedical-devices
Reprocessing of Single Use Medical Devices Communication to Stakeholders,

2019 Nov

1pdfDownloadcommunication-to-industry position-statementmedical-devices
2.32Wound Dressings,

2011 Nov

1Downloadcommunication-to-industry position-statementmedical-devices
9.103Tissue Engineering Products,

2017 Nov

1Downloadcommunication-to-industry position-statementmedical-devices
9.105Section 21 Authorisation of Sale Unregistered Medical Devices,

2017 Nov

1, , , Downloadcommunication-to-industry position-statementemergency-use medical-devices section-21 unregistered-products
9.106Class A Medical Devices,

2017 Sep

1Downloadcommunication-to-industry position-statementmedical-devices
9.78Disinfectants Status of Antiseptics and Germicides,

2016 Jul

1Downloadcommunication-to-industry position-statementmedical-devices
9.79Medical Device Establishments: License Requirements,

2016 Sep

1Downloadcommunication-to-industry position-statementmedical-devices
9.96Transitional Arrangements for Medical Devices,

2017 Apr

1Downloadcommunication-to-industry position-statementmedical-devices
8.10FAQ: Licencing of medical device establishments,

2017 Nov

1Downloadfaq other-documentsmedical-devices
WHO Global Model Regulatory Framework for Medical Devices including IVD medical devices,

2017 Jan

1pdfDownloadother-documents who-documentmedical-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
2.48Veterinary Medicines Exemptions guidelines

2020 Mar

1, Downloadguidelinequality veterinary-medicines
SAHPGL-PEM-VET-02Veterinary Medicines Clinical Guideline

2022 Sept

2, pdfDownloadguidelinequality veterinary-medicines
Annual Report (2020/2021)

2021 May

1pdfDownloadannual-reportcorporate
Annual Report (2019/2020)

2020 May

1pdfDownloadannual-reportcorporate
Annual Report (2018/2019)

2019 May

1pdfDownloadannual-reportcorporate
MD030Medical Device Establishment Licence Renewal – ISO13485 Certificate Communication

2022 Feb

1pdfDownloadcommunication-to-industrymedical-devices
MD031Medical Device Establishment Licence Renewal Process

2022 Sep

2pdfDownloadcommunication-to-industrymedical-devices
2.07Dissolution

2015 Jun

5Downloadguidelinegeneral-ectd-human-medicines-guidelines
2.40Multiple submissions of the same application for registration with different proprietary names

2019 May

4Downloadguidelinegeneral-ectd-human-medicines-guidelines
9.132Priority Review Requests Communication,

2022 Feb

1Downloadcommunication-to-industry guidelinegeneral-ectd-human-medicines-guidelines
REQUESTS: Existing Category D (Complementary Medicines) Registration Applications (07 October 2021)

2022 Feb

1pdfDownloadcommunication-to-industrycomplementary-medicines
7.04Communication to industry – 7.04 Health Supplements Safety and Efficacy

2022 Mar

1pdfDownloadcommunication-to-industrycomplementary-medicines
Submission of Post-Importation Testing Exemption requests for Biological and Biosimilar Medicines

2022 Mar

1, pdfDownloadcommunication-to-industrybiological-medicines-evaluation-and-research inspectorate-and-good-manufacturing-practices
Upcoming SAHPRA and Industry workshop

2022 Mar

1pdfDownloadcommunication-to-industrymedical-devices
Communication to Stakeholders with regards to the current status of the Medical Device Regulations

2022 Mar

1pdfDownloadcommunication-to-industrymedical-devices
MD032ISO 13485 Conformity Assessment Body Communication

2022 Aug

2pdfDownloadcommunication-to-industrymedical-devices
MD034Conditions for use of COVID-19 antigen self-test kits

2022 Mar

1pdfDownloadcommunication-to-industrymedical-devices
MD035Usability studies for Covid-19 self-testing kits requirements

2022 Mar

1pdfDownloadcommunication-to-industrymedical-devices
Conformity assessment body(cab) requirements for recognition by Sahpra checklist,

2022 Mar

1pdfDownloadchecklist communication-to-industrymedical-devices
Conformity of assessment body DoC template,

2022 Mar

1docxDownloadcommunication-to-industry templatesmedical-devices
MD033Specification criteria for COVID-19 rapid antigen selftests

2022 Mar

1pdfDownloadcommunication-to-industrymedical-devices
SAHPGL-PEM-BIO-06General guidance document on QSE for Biological Medicines

2022 Aug

2pdfDownloadguidelinebiological-medicines-evaluation-and-research
Cannabis and related substances

2020 Feb

1pdfDownloadnewsletterregulatory-compliance
SAHPRA backlog clearance programme newsletter August 2020

2020 Aug

1pdfDownloadnewsletterbacklog
VigiGuardian Newsletter April 2022

2022 Apr

1pdfDownloadnewsletterpharmacovigilance
SAHPGL-GOV-01Guideline for appeals against Regulatory decisions

2022 Apr

1pdfDownloadguidelinequality-management-system
SAHPGL-CEM-PV-01Pharmacovigilance Inspections for Human Medicinal Products

2022 May

1pdfDownloadguidelinepharmacovigilance
SAHPGL-CEM-PV-02Pharmacovigilance systems

2022 May

1pdfDownloadguidelinepharmacovigilance
SAHPGL-CEM-NS-01Application for rescheduling of a substance or medicine

2022 May

1pdfDownloadguidelinenames-and-scheduling
Payment of annual retention fees for registered products

2022 May

1pdfDownloadcommunication-to-industrygeneral-ectd-human-medicines-guidelines
SAHPGL-PEM-BIO-01Guideline for Lot Release of Human Vaccines

2022 Sep

3pdfDownloadguidelinebiological-medicines-evaluation-and-research
GLF-PEM-BIO-01AApplication Form for Lot Release of Human Vaccine,

2022 Sep

2pdfDownloadapplication-forms formbiological-medicines-evaluation-and-research
Communication to Industry – Applications for GMP and CPP Certificates

2022 Jun

1pdfDownloadcommunication-to-industryinspectorate-and-good-manufacturing-practices
SAHPRA’s Vaccine Authorisation Process

2021 Sep

1pdfDownloadpresentationsbiological-medicines-evaluation-and-research
COVID-19 vaccines Regulatory Status Update

2021 Jan

1pdfDownloadpresentationsbiological-medicines-evaluation-and-research
Update on COVID-19 Diagnostic tests

2020 May

1pdfDownloadpresentationsmedical-devices
PRESENTATION TO THE NCC- MINISTER OF HEALTH- 19 MAY 2020

2020 May

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PARLIAMENTARY PORTFOLIO COMMITTEE ON HEALTH- COVID-19

2020 Apr

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Cannabis and Related Substances Legislation and Regulation

2021 Mar

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The Status of Cannabis for Medicinal and Research Purposes

2019 Oct

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SA’s Covid-19 epidemic: Trends & Next steps

2020 Apr

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SAHPRA’s Annual Performance Plan: 2019-2020

2019 Sep

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Radiation Control

2019 Oct

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Cannabis presentation

2022 Jun

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GOV01_V01PAIA Manual

2021 Apr

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OF-GOV-01ARequest for access to record of held by SAHPRA (PAIA form)

2021 Apr

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Retention Fee Notification – 9 June 2022

2022 Jun

1, , , pdfDownloadcommunication-to-industrybiological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines inspectorate-and-good-manufacturing-practices medical-devices
Communication on Medicines Registration Renewals Implementation Framework,

2022 Jun

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SAHPGL-CEM-PV-04POST-MARKETING REPORTING OF ADVERSE DRUG REACTIONS TO HUMAN MEDICINES IN SOUTH AFRICA

2022 Jun

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Summary of Medicines Safety Regulatory Decisions

2022 Jun

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SAHPGL-INSP-RC-05Guidelines for Medicine Recalls – Withdrawals and Rapid Alerts

2022 Jun

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SAHPGL-INSP-RC-06 Guideline to Fee Determination and Payments of Permits and Related Authorisations

2022 Jun

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SAHPGL-INSP-RC-07Guidelines for Advertisement of Medicines and Health Products

2022 Jun

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SAHPGL-INS-RC-11Guideline for Release of Import Health Products at Ports of Entry

2022 Jun

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SAHPGL-INS-RC-1Guidelines for Market Surveillance Of Medicines

2022 Jun

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Communication to Industry on Nitrosamine Review for New Applications and Registered Products including Biologicals

2022 Jun

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SAHPGL-HPA-04Renewal of Human and Veterinary Medicines Requirements and Process

2022 Jun

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SAHPGL-LIC-02Guideline on How to Apply for A Licence to Act as A Wholesaler

2022 Jun

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SAHPGL-LIC-03Guideline on How to Amend a Current Licence

2022 Jun

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Cannabis and related substances

2020 Jan

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MD036COVID-19 Test Kits Batch Verification

2022 Jun

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Guideline on completion of the veterinary medicines clinical trial application form

2019 Sep

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SAHPGL-PEM-VET-01Guideline on application for use of unregistered veterinary medicines

2022 Aug

3, , , pdfDownloadguidelineemergency-use section-21 unregistered-products veterinary-medicines
2.44Guideline For Cultivation Of Cannabis And Manufacture Of Cannabis-Related Pharmaceutical Products For Medicinal And Research Purposes

2017 Sep

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40869Medicines And Related Substances Act, 1965 (Act no. 101 Of 1965) as amended

2017 May

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41064General Regulations

2017 Aug

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No. 3834Hazardous Substances Act (Act No. 15 Of 1973)

2017 May

94pdfDownloadactcorporate
No. 26595National Health Act, 2003 (Act No. 61 Of 2003)

2004 Jul

469pdfDownloadactcorporate
No. 3751Fertilisers, farm feeds, agricultural remedies and stock remedies act, 1947 (act no. 36 of 1947)

1947 Jan

CXLVIIpdfDownloadactcorporate
No. 9152Animal Diseases Act, 1984 (Act No. 35 Of 1984)

1984 Apr

226pdfDownloadactcorporate
No. 8051Veterinary And Para-veterinary Professions Act, 1982 (Act No. 19 Of 1982)

1982 Mar

201pdfDownloadactcorporate
No. 14143Drugs And Drug Trafficking Act, 1992 (Act No. 140 Of 1992)

1992 Jul

329pdfDownloadactcorporate
SAHPGL-RDN-RN-05Guideline On Afterloader Source Exchange Forms (RNXM)

2022 Jul

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The Innovation In Regulatory Sciences Capacity Development In Africa Meeting

2020 Jun

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SAHPRA Annual Performance Plan 2022 – 2023

2022 Jun

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SAHPRA Annual Performance Plan 2021 – 2022

2021 Oct

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SAHPRA Annual Performance Plan 2020 – 2021

2020 Jun

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Strategic Framework

2020 Jul

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SAHPRA Strategic Plan 2020 and 2021 – 2024 and 2025

2022 Jun

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Expression Of Interest: SADC Medicines Regulatory Worksharing, Zazibona Collaborative Process,

2019 Oct

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VigiGuardian Newsletter July 2022

2022 Jul

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No. 3530Foodstuffs, Cosmetics And Disinfectants Act, 1972 (Act No. 54 Of 1972) As Amended

1972 Jun

84pdfDownloadactcorporate
No. 19519Environmental Management Act: Waste Management Act, 1998 (Act No. 107 Of 1998)

1998 Nov

401pdfDownloadactcorporate
Health Professions Act, 1974 (Act No. 56 Of 1974)

1975 Feb

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No. 8883Nursing Act, 1978 (Act No. 50 Of 1978)

2006 May

491pdfDownloadactcorporate
No. 4442Pharmacy Act, 1974 (Act No. 53 Of 1974)

1974 Oct

112pdfDownloadactcorporate
No. 866Customs And Excise Act, 1964 (Act No. 91 Of 1964)

1964 Jul

XIIIpdfDownloadactcorporate
No. 18491Basic Conditions Of Employment Act, 75 Of 1997

1997 Dec

390pdfDownloadactcorporate
No. 20852Promotion Of Access To Information Act 2 Of 2000

2000 Feb

416pdfDownloadactcorporate
No. 20853Promotion Of Administrative Justice Act 3 Of 2000

2000 Feb

316pdfDownloadactcorporate
No. 25899Broad-based Black Economic Empowerment Act 2003

2004 Jan

463pdfDownloadactcorporate
No. 45673Published Gazette – Extension Notice (SECTION 18 OF ACT 101)

2021 Dec

678pdfDownloadgovernment-gazettecorporate
No. 43484Published Gazette – Alcohol based hand sanitiser 2020

2020 Jun

721pdfDownloadgovernment-gazettecorporate
No. 43347Amendment To Schedules – CBD-containing Products 2020

2020 May

659pdfDownloadgovernment-gazettecorporate
No. 41064General Regulations – Medicines And Related Substances Act, 1965 (25 August 2017),

2017 Aug

859pdfDownloadgovernment-gazette regulationcorporate
No. 43346Exclusion Of Medicines, Medical Devices And (IVDs) Donated To The State

2020 May

659pdfDownloadgovernment-gazettecorporate
No. 44026Regulations Regarding Fees Payable In Terms Of The Provisions Of The Medicines And Related Substances Act, 1965 (Act No. 101 Of 1965)

2020 Dec

666pdfDownloadgovernment-gazettecorporate
NSTF-South 32 Awards 2021-2022

2022 Jul

1pdfDownloadnewslettercorporate
Electronic Submission Of Adverse Drug Reaction (ADR) Reports – E2b Reporting

2022 Aug

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SAHPRA Digital Transformation – Deployment of a Stakeholder portal

2022 Aug

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2.21South African Specification for eCTD Regional Module1

2019 May

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Medical Examinations For Radiation Workers

2009 Jul

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SAHGPL-RDN-XR-19Guideline for Management of Pregnant Radiographers and Other Staff Members

2022 Sept

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Internal rules – Minimum requirements

2009 Jul

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Leak tests

2005 Sep

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Licensing Requirements For New Nuclear Medicine Practices

2014 Sep

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RN-INF-RPO-001RPO Competence and Training – Interim Position Document

2013 Aug

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Guidelines Regarding Organisational Requirements For Authority Holders And Their Appointed Radiation Protection Officers In Respect Of Group Iv Hazardous Substances

2009 Jul

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Code of Practice – Safe use of soil moisture and density gauges

2019 Jul

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SAHPGL-RDN-XR-15Guideline for Ionising Radiation Dose Limits and Annual Limits on Intake of Radioactive Material

2022 Aug

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FIREProtective measures to take in the event of an accident involving radioactivity

2001 Feb

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GAUGECode of Practice for the safe use of industrial gauges containing radioactive sources

2019 May

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IRCP91-2Industrial radiography (gamma radiography)

2019 May

2, Downloadguidelineradiation-control radionuclides
RN-GLN-EPR-001Guidelines for Reporting National Radiation Occurrence

2018 Jul

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RN-GLN-MED-131Iodine-131 therapy

2009 Jul

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RN-REQ-SRC-001Label sources & containers

2014 Jul

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TRUG91-1Safe transport of radioactive material

2005 May

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UNSEALSafe use of unsealed radioactive nuclides

2001 Feb

2, Downloadguidelineradiation-control radionuclides
Wscp91-1Management and disposal of non-nuclear radioactive waste

2005 May

2, Downloadguidelineradiation-control radionuclides
SAHPGL-RDN-XR-21Guideline for Patient Dose Measurements in Diagnostic Radiology

2022 Sept

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SAHPGL-RDN-XR-22Guideline for Protective Clothing

2022 Sept

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SAHPGL-RDN-XR-20Guideline for Use of Radiographic Grid Ratio

2022 Sept

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SAHPGL-RDN-XR-10Guideline For Radiation Monitoring Requirements And Radiation Occurrences

2022 Aug

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SAHPGL-RDN-XR-18Guidelines on Requests for Medical X-Ray Examinations

2022 Sept

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SAHPGL-RDN-XR-14Guideline of Test Procedures for Film Processing and Intensifying Screens

2022 Aug

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SAHPGL-RDN-XR-01Guideline for QC in Medical Diagnostic X-Ray Imaging Systems

2022 Aug

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SAHPGL-RDN-XR-13Guideline for QC in Dental Diagnostic X-Ray Imaging Systems

2022 Aug

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SAHPGL-RDN-XR-08Guideline for Personal Monitoring Med and Vet Use of Diagnostic X-Ray Equipment

2022 Aug

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SAHPGL-RDN-XR-05General Guideline For Cabinet And Conveyer Belt X-ray

2022 Aug

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SAHPGL-RDN-XR-11General Guidelines with Regards to the Design of X-Ray Rooms

2022 Aug

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SAHPGL-RDN-XR-02Guideline For Code Of Practice For Users Of Medical Xray Equipment

2022 Aug

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SAHPGL-RDN-XR-06Guideline For Reducing Radiation Risk From Computer Tomography For Pediatric And Small Adult Patients

2022 Aug

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SAHPGL-RDN-XR-04Guideline for Minimum Requirements For Fixed Diagnostic X-Ray Installations

2022 Aug

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SAHPGL-RDN-XR-12Guideline for Monitoring of Radiation workers in a Theatre

2022 Aug

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SAHPGL-RDN-XR-07Guideline for Bone Densitometer – Operators

2022 Aug

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SAHPGL-RDN-XR-16Guideline for Code of Practise for Industrial Radiography X-Ray

2022 Aug

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SAHPGL-RDN-XR-09Guideline For Code Of Practice For Users Of Non – Medical X-RAY Equipment – Forensic

2022 Aug

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SAHPGL-RDN-XR-23Guideline Radiologist Available by Remote Digital Connection

2022 Sept

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SAHPGL-RDN-XR-03Guideline for Dental Radiography

2022 Aug

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DHCPLTopical Corticosteroid – Risk of Withdrawal Reactions – Aspen

2022 Aug

2pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLVSIQQ® (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

2021 Nov

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLCOMIRNATY® (COVID-19 mRNA Vaccine) -Warning regarding rare cases of Myocarditis and Pericarditis

2021 Aug

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLSAHPRA Statement on Adverse Events Following Immunisation (AEFIs) with COVID 19 Vaccines

2021 Aug

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DHCPLCOVID-19 Vaccine Janssen

2021 Jul

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLSelective Serotonin Reuptake Inhibitors (SSRIS) and Serotonin–Norepinephrine Reuptake Inhibitors (SNRIS) associated with the risk of Postpartum Haemorrhage

2021 Jun

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DHCPLDopaminergic Medicines used in the treatment of Parkinson’s Disease: Risk of Dopamine Dysregulation Syndrome

2021 May

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DHCPLCOVID-19 Vaccine Janssen: Risk of Thrombosis in combination with Thrombocytopenia

2021 Nov

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DHCPLSAHPRA launches the Med Safety App for self-reporting of suspected Adverse Drug Reactions by the Public and Healthcare Professionals

2021 Apr

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DHCPLRisk Of Drug Induced Liver Injury Associated With The Use Of Metamizole-containing Medicines

2021 Mar

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DHCPLIncreased 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

2021 Feb

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DHCPLEltroxin 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.

2020 Dec

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DHCPLDiphenhydramine-containing Medicines

2020 Nov

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DHCPLDopaminergic medicines used in the treatment of parkinson’s disease: Risk of Dopamine dysregulation syndrome

2020 Oct

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DHCPLTecentriq® (atezolizumab): Risk of Severe Cutaneous Adverse Reactions (SCARs) and Immune-related myositis

2020 Nov

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DHCPLRisk of dopamine dysregulation syndrome (DDS) associated with the use of dopaminergic medicines used for the treatment of Parkinson’s disease (PD).

2021 Nov

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DHCPLFluoropyrimidine containing medicines and related substances: Increased drug exposure and toxicity in patients with dihydropyrimidine dehydrogenase (DPD) deficiency

2020 Oct

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DHCPLTyrosine kinase inhibitors

2020 Jun

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLOndansetron: Warning about small increased risk of oral clefts following use in the first 12 weeks of pregnancy

2020 Jun

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DHCPLSandoz and Novartis: Warning about small increased risk of oral clefts following use in the first 12 weeks of pregnancy

2020 Jun

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DHCPLFluoroquinolones: risk of mitral and aortic regurgitation associated with the use of oral and injectable fluoroquinolones

2020 Jun

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLDHCPL for ACE-inhibitor/Angiotensin receptor blocker containing medicines

2019 Oct

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLIncreased risk of thrombo-embolic events in patients with anti-phopholipid syndrome (APS) treated with Eliquis

2019 Sep

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DHCPLIncreased risk of thrombo-embolic events in patients with anti-phopholipid syndrome (APS) treated with Xarelto

2019 Aug

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DHCPLIncreased risk of thrombo-embolic events in patients with anti-phopholipid syndrome (APS) treated with Pradaxa

2019 Aug

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DHCPLRisk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers – 1 August 2019

2019 Ag

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DHCPLRisk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers

2019 Aug

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DHCPLRisk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers

2019 Jul

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLRisk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers

2019 Jun

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLRisk of Acute Kidney Injury with concomitant use of Fluoroquinolones and Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers

2019 Jun

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
DHCPLDolutegravir – Risk of neural tube defects

2019 Apr

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DHCPLGadolinium-Based Contrast Agents – Deposition in the brain

2019 Apr

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DHCPLEPOETIN ALFA – New warnings on severe cutaneous adverse reaction

2019 Apr

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DHCPLAmphotericin B – Risk of Medication Error

2019 Apr

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DHCPLHyoscine Butylbromide – Risk of adverse effects in patients with underlying cardiac disease

2019 Apr

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DHCPLLamotrigine – Risk of Hemophagocytic Lymphohistiocytosis

2019 Apr

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DHCPLHydrochlorothiazide – Risk of non-menoloma skin cancer

2019 Apr

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DHCPLClozapine – Induced gastrointestinal hypomotility

2019 Apr

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DHCPLValproate containing medicines – High risk of congenital abnormalities and development disorders

2019 Apr

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DHCPLCefepime hydrochloride – Risk of serious adverse reactions

2019 Apr

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Anagrelide hydrochloride: Risk of thrombosis including cerebral infarction upon abrupt treatment discontinuation

2022 Aug

1pdfDownloadcommunication-to-health-care-professionalspharmacovigilance
GLF-CEM-PV-06AAdverse Drug Reactions and Quality Problem Reporting Form

2022 Aug

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Missing Applications – Call to Industry

2022 Aug

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MD037Withdrawal of Section 21 Authorisation for use of unregistered rapidly developed non-invasive ventilators

2022 Jul

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

2022 Aug

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OF-PEM-VET-01EApplication form for unregistered veterinary medicines (Section 21),

2022 Aug

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Veterinary Clinical Trial Application Template

2019 Dec

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Owner Consent Form,

2019 Jul

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SAHPGL-RDN-XR-17Guideline for Disposal of X-Ray Units and Tubes Containing Beryllium

2022 Aug

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SAHPGL-S21-01Waivers From Certain Medicine Registration Requirements For Medicines For Human Use

2022 Aug

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2.05Stability Guideline

2012 Aug

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1.2.1Application For Registration Of A Medicine Module 1: Administrative Information Application Form,

2020 Feb

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Extension on commentary period for Borderline Products Guideline

2022 Sep

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Over-arching: Good Review Practice Guide,

2022 Jun

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OF-PEM-VET-04BVeterinary Medicines Biowaiver Application Form for Parenterals

2022 Sept

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GLF-PEM-VET-04AResidue Overall Summary (ROS)

2022 Sept

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OF-PEM-VET-04ABioequivalence Trial Information for Veterinary Medicines

2022 Sept

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No. 46789Medicines and Related Substances Act Schedules

2022 Aug

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SAHPP-QA-01Quality Policy Statement

2021 Feb

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