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About us
Who we are
Board
Executive Management
Expressions of Interest
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
Forms
Guidelines
Inspectorate and Regulatory Compliance
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
Acts and Regulations
Forms
Guidelines & Codes of Practice
News & Updates
Safety Information
Covid-19 Adverse Events Report
Health Product Vigilance
Product Recalls
Rapid Alerts
Recalls Reporting
Report Side Effects
Safety Alerts
Unregistered Products
Category A Medicines
Complementary Medicines
Medical Devices
Veterinary Medicines
Veterinary Medicines
Guidelines
Registered Vet Products
Veterinary Portal
Databases & Registers
Medical Devices Licences Issued
OTC Medicines Directory
Pharma Licenced Establishments
Revoked or Suspended Pharma Licences
PI & PIL Repository
Registered Health Products
Registered Vet Products
E-Services
Adverse Drug Reaction Reporting
AEFI Reporting Dashboard
Complementary Medicines Licensing
COVI-VIG Reporting System
Health Product Application Status Checker
Lot Release Search
OTC Medicines Directory
Product Variations Portal
Med Safety App
Registered Health Products
Section 21 Applications
Variations Status Checker
Veterinary portal
E-Library
Corporate & Publications
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PHARMACOVIGILANCE GUIDELINES
Document Number
Title
Categories
Date updated
Version
Units
File Type
Link
doc_categories_hfilter
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SAHPGL-CEM-PV-06
Guideline For Adverse Drug Reactions (ADRs) Reporting for Healthcare Professionals
Guideline
2022 Aug
3
pharmacovigilance
pdf
Download
guideline
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
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-PV-04
POST-MARKETING REPORTING OF ADVERSE DRUG REACTIONS TO HUMAN MEDICINES IN SOUTH AFRICA
Guideline
2022 Jun
9
pharmacovigilance
pdf
Download
guideline
pharmacovigilance
SAHPGL-CEM-PV-03
Risk Management Plans for Medicines for Human Use
Guideline
2022 Sep
1
pharmacovigilance
pdf
Download
guideline
pharmacovigilance
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