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About us
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Communication to Industry
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Acts and Regulations
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Guidelines & Codes of Practice
News & Updates
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Covid-19 Adverse Events Report
Health Product Vigilance
Product Recalls
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Report Side Effects
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Unregistered Products
Category A Medicines
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Guidelines
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Veterinary Portal
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PI & PIL Repository
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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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2.30
Biosimilar Medicines Guidance
Guideline
2014 Aug
3
Biological Medicines Evaluation and Research
Download
guideline
biological-medicines-evaluation-and-research
SAHPGL-PEM-BIO-03
Guideline for Pre-Registration Consultation Meeting
Guideline
2022 Sep
2
Biological Medicines Evaluation and Research
pdf
Download
guideline
biological-medicines-evaluation-and-research
SAHPGL-PEM-BIO-04
Biological medicines stability Guideline
Guideline
2022 Aug
2
Biological Medicines Evaluation and Research
pdf
Download
guideline
biological-medicines-evaluation-and-research
SAHPGL-PEM-BIO-05
Biological Medicines Amendment guideline
Guideline
2022 Sep
5
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
2022 Aug
2
Biological Medicines Evaluation and Research
pdf
Download
guideline
biological-medicines-evaluation-and-research
SAHPGL-PEM-BIO-01
Guideline for Lot Release of Human Vaccines
Guideline
2022 Sep
3
Biological Medicines Evaluation and Research
pdf
Download
guideline
biological-medicines-evaluation-and-research
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