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About us
Who we are
Board
Executive Management
Expressions of Interest
Digital Transformation
Quality Management System
Regulatory Partnerships
Special Projects
Backlog
Vacancies
Tenders
Operational Units
Biologicals
Communication to Industry
Forms
Guidelines
Complementary Meds
Application portal
Communication to Industry
Forms
Guidelines
Templates
Clinical Trials
Communication To Industry
FAQs
Forms
Guidelines
Inspectorate and Regulatory Compliance
Importation – Border Control
Medical Devices
Communication to Industry
Forms
Guidelines
Conformity assessment bodies
Licenced Establishments
Position Statements
Related Documents
Test Kits
Names and Scheduling
Amended Schedules
Consolidated Schedules
Guidelines
Orthodox Medicines
Communication to Industry
Forms
Guidelines
Registered Health Products
Templates
Radiation Control
Communication To Industry
Acts and Regulations
Forms
Guidelines & Codes of Practice
Inspection bodies
News & Updates
Safety Information
Vigilance
Covid-19 Adverse Events Report
Health Product Vigilance
Product Recalls
Rapid Alerts
Recalls Reporting
Report Side Effects
Safety Alerts
Unregistered Products/Section 21
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Medical Devices
Veterinary Medicines
Veterinary Medicines
Guidelines
Registered Vet Products
Veterinary Portal
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OTC Toolkit
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Revoked or Suspended Pharma Licences
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Registered Health Products
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E-Services
Adverse Drug Reaction Reporting
AEFI Reporting Dashboard
Complementary Medicines Licensing
COVI-VIG Reporting System
Health Product Application Status Checker
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OTC Medicines Directory
OTC Toolkit
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Title
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Date Updated
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CT03-2023
COVID-19 Clinical Trials – Two-Weekly Progress Reports
Communication to industry
02/01/2024
1
Clinical Evaluations Management
,
Clinical Trials
pdf
Download
Clinical Trial Applications Electronic System
Communication to industry
13/12/2023
1
Clinical Evaluations Management
,
Clinical Trials
pdf
Download
HPA03
Priority Review Requests Communication
Communication to industry
11/12/2023
3
General ECTD & human medicines
pdf
Download
Clinical Trials Committee and Submission Dates for 2024
Communication to industry
,
Guideline
12/10/2023
1
Clinical Evaluations Management
,
Clinical Trials
pdf
Download
MD038
SAHPRA position on EU regulatory transition for medical devices from MDD/AIMDD/IVDD to MDR 2017/745 /IVDR 2017/746
Communication to industry
02/10/2023
1
Medical Devices
,
Radiation Control
pdf
Download
HPA-08
FAQs on Medicine Registration Renewals
Communication to industry
22/08/2023
5
General ECTD & human medicines
,
HPA
pdf
Download
HPA01-2022
Medicines Registration Renewals Implementation Framework
Communication to industry
22/08/2023
6
General ECTD & human medicines
pdf
Download
Process Flow of Importation of Medical Products Published
Communication to industry
17/07/2023
1
Inspectorate and good manufacturing practices
,
Regulatory Compliance
pdf
Download
HPA13
Digital Variations Portal (DVP) User Changes
Communication to industry
11/07/2023
1
General ECTD & human medicines
pdf
Download
B-BBEE Policy for Issuance of Licences as per Section 22c of the Medicines Act
Communication to industry
23/06/2023
1
Legal
pdf
Download
Annual retention fee payment notification for the Financial year ending 31 March 2024
Communication to industry
08/06/2023
1
Finance
pdf
Download
Communication to industry – SAHPRA Statement on Regulation of Category D Medicines
Communication to industry
02/06/2023
1
Complementary Medicines
pdf
Download
Communication to Industry – Summary of Medicine Safety Regulatory Decisions
Communication to industry
02/06/2023
1
Pharmacovigilance
pdf
Download
HPA12
Communication to Industry – Health Products Register Notification
Communication to industry
31/05/2023
1
HPA
pdf
Download
PEM03-2022/23
Implementation of the QOS and QIS
Communication to industry
23/05/2023
1
General ECTD & human medicines
,
PEM Pre-Reg
,
Pharmaceutical Evaluation Management
pdf
Download
Summary of Medicine Safety Regulatory Decisions
Communication to industry
13/04/2023
1
Pharmacovigilance
pdf
Download
Verification of Fees and Bank details
Communication to industry
22/02/2023
1
Finance
pdf
Download
HPA-11
Communication on Hard Copy Registration Certificates
Communication to industry
17/02/2023
1
General ECTD & human medicines
,
HPA
pdf
Download
Communication to Industry – Importing and operating unlicensed dental X-ray equipment
Communication to industry
16/02/2023
1
Radiation Control
pdf
Download
HPA-10
Communication to Industry – Pilot Application Process through the SAHPRA Service Desk
Communication to industry
01/02/2023
1
General ECTD & human medicines
,
HPA
pdf
Download
Certification Variation Screening – Type II Proprietary Name Change Applications and TOAs
Communication to industry
14/12/2022
2
General ECTD & human medicines
pdf
Download
HPA09
Pre-registration veterinary medicines tracker guide
Communication to industry
08/12/2022
1
General ECTD & human medicines
,
Veterinary medicines
pdf
Download
Communication on Medicines Registration Renewals Implementation Framework
Communication to industry
24/11/2022
2
Biological Medicines
,
General ECTD & human medicines
,
Quality
,
Veterinary medicines
pdf
Download
Expression of Interest-WHO Pre-Qualification Collaborative Registration Procedure
Communication to industry
17/11/2022
1
General ECTD & human medicines
pdf
Download
HPA07
Certification Variation Screening – Type II Proprietary name change applications and TOA’s
Communication to industry
20/10/2022
1
General ECTD & human medicines
pdf
Download
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