Subscribe
About us
Who we are
Board
Executive Management
Expressions of Interest
Quality Management System
Corporate Documents
Regulatory Partnerships
Agreements/MOUs
Technical Advisory Committees
Special Projects
Backlog
Digital Transformation
eCTD Submissions Portal
Vacancies
Tenders and RFQs
Operational Units
Biologicals | Blood | Vaccines
Communication to Industry
Forms
Guidelines
Complementary Meds
Application portal
Communication to Industry
Forms
Guidelines
Templates
Clinical Trials
Communication To Industry
FAQs
Forms
Guidelines
Inspections | Licences | Compliance
Importation – Border Control
Medical Devices
Communication to Industry
Forms
Guidelines
Conformity assessment bodies
Licenced Establishments
Position Statements
Related Documents
Test Kits
Who Collaborative Procedure
Names and Scheduling
Amended Schedules
Consolidated Schedules
Forms
Guidelines
Orthodox Medicines
Communication to Industry
Engagement Portal
Forms
Guidelines
Registered Health Products
Templates
Radiation Control
Communication To Industry
Acts and Regulations
Forms
Templates
Guidelines & Codes of Practice
Inspection bodies
News & Updates
Safety Information
Pharmacovigilance
Covid-19 Adverse Events Report
Health Product Vigilance
Product Recalls
Rapid Alerts
Recalls Reporting
Report Side Effects
Safety Alerts
Unregistered Products/Section 21
Category A Medicines
Engagement Portal
Complementary Medicines
Medical Devices
Veterinary Medicines
Veterinary Medicines
Forms
Guidelines
Registered Vet Products
Veterinary Portal
Databases & Registers
Medical Devices Licences Issued
OTC Medicines Directory
OTC Toolkit
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
eCTD Submissions Portal
Engagement Portal
Health Product Application Status Checker
Health Products Variations Status Checker
Lot Release Search
Med Safety App
Mpox Monitoring
OTC Medicines Directory
OTC Toolkit
Product Variations Portal
Registered Health Products
Section 21 Applications
Service Desk System
VET Status Checker
VET Variation Status Checker
E-Library
Acts, Regulations & Policies
Acts
Govt Gazettes And Regulations
Policies
Corporate & Publications
Annual Reports
Documents For Comments
Fees
Newsletters
Planning Documents
Position Statements
Published Papers
Forms
Guidelines
Guidelines Notice Board
Presentations
Templates
Toolkits
Tutorials
News
News & Updates
Press Releases
In the Media
Communication to Industry
Documents For Comments
Events
Safety Alerts
THC and CBD Information
Contact Us
General Enquiries
Key Contacts
Media enquiries
Our Offices
Whistleblower/Non-Compliance Reporting
Recalls Reporting
About us
Who we are
Board
Executive Management
Expressions of Interest
Quality Management System
Corporate Documents
Regulatory Partnerships
Agreements/MOUs
Technical Advisory Committees
Special Projects
Backlog
Digital Transformation
eCTD Submissions Portal
Vacancies
Tenders and RFQs
Operational Units
Biologicals | Blood | Vaccines
Communication to Industry
Forms
Guidelines
Complementary Meds
Application portal
Communication to Industry
Forms
Guidelines
Templates
Clinical Trials
Communication To Industry
FAQs
Forms
Guidelines
Inspections | Licences | Compliance
Importation – Border Control
Medical Devices
Communication to Industry
Forms
Guidelines
Conformity assessment bodies
Licenced Establishments
Position Statements
Related Documents
Test Kits
Who Collaborative Procedure
Names and Scheduling
Amended Schedules
Consolidated Schedules
Forms
Guidelines
Orthodox Medicines
Communication to Industry
Engagement Portal
Forms
Guidelines
Registered Health Products
Templates
Radiation Control
Communication To Industry
Acts and Regulations
Forms
Templates
Guidelines & Codes of Practice
Inspection bodies
News & Updates
Safety Information
Pharmacovigilance
Covid-19 Adverse Events Report
Health Product Vigilance
Product Recalls
Rapid Alerts
Recalls Reporting
Report Side Effects
Safety Alerts
Unregistered Products/Section 21
Category A Medicines
Engagement Portal
Complementary Medicines
Medical Devices
Veterinary Medicines
Veterinary Medicines
Forms
Guidelines
Registered Vet Products
Veterinary Portal
Databases & Registers
Medical Devices Licences Issued
OTC Medicines Directory
OTC Toolkit
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
eCTD Submissions Portal
Engagement Portal
Health Product Application Status Checker
Health Products Variations Status Checker
Lot Release Search
Med Safety App
Mpox Monitoring
OTC Medicines Directory
OTC Toolkit
Product Variations Portal
Registered Health Products
Section 21 Applications
Service Desk System
VET Status Checker
VET Variation Status Checker
E-Library
Acts, Regulations & Policies
Acts
Govt Gazettes And Regulations
Policies
Corporate & Publications
Annual Reports
Documents For Comments
Fees
Newsletters
Planning Documents
Position Statements
Published Papers
Forms
Guidelines
Guidelines Notice Board
Presentations
Templates
Toolkits
Tutorials
News
News & Updates
Press Releases
In the Media
Communication to Industry
Documents For Comments
Events
Safety Alerts
THC and CBD Information
Contact Us
General Enquiries
Key Contacts
Media enquiries
Our Offices
Whistleblower/Non-Compliance Reporting
Recalls Reporting
Medical Devices and in Vitro Diagnostics Application Forms
How to complete an application for
Manufacturers
of Medical Devices and IVDs
How to complete an application for
Distributors
of Medical Devices and IVDs
How to Complete a Medical Devices
Wholesaler
Licence Application | Step-by-Step Guide
Search for:
Search Button
