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About us
Who we are
Board
Executive Management
Expressions of Interest
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Regulatory Partnerships
Special Projects
Backlog
Vacancies
Tenders
Operational Units
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Communication to Industry
Forms
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Complementary Meds
Application portal
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Forms
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Communication To Industry
Forms
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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
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/Section 21
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
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E-Services
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AEFI Reporting Dashboard
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Biological Medicines Evaluation And Research Unit (BMERU) Guidelines
Document Number
Title
Categories
Date Updated
Version
Units
File Type
Link
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SAHPGL-PEM-BIO-01
Guideline for Lot Release of Human Vaccines
Guideline
07/09/2022
3
Biological Medicines Evaluation and Research
pdf
Download
guideline
biological-medicines-evaluation-and-research
SAHPGL-PEM-BIO-06
General guidance document on QSE for Biological Medicines
Guideline
24/08/2022
2
Biological Medicines Evaluation and Research
pdf
Download
guideline
biological-medicines-evaluation-and-research
SAHPGL-PEM-BIO-05
Biological Medicines Amendment guideline
Guideline
22/09/2022
5
Biological Medicines Evaluation and Research
pdf
Download
guideline
biological-medicines-evaluation-and-research
SAHPGL-PEM-BIO-04
Biological medicines stability Guideline
Guideline
18/08/2022
2
Biological Medicines Evaluation and Research
pdf
Download
guideline
biological-medicines-evaluation-and-research
SAHPGL-PEM-BIO-03
Guideline for Pre-Registration Consultation Meeting
Guideline
13/09/2022
2
Biological Medicines Evaluation and Research
pdf
Download
guideline
biological-medicines-evaluation-and-research
2.30
Biosimilar Medicines Guidance
Guideline
22/08/2014
3
Biological Medicines Evaluation and Research
Download
guideline
biological-medicines-evaluation-and-research
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