BIOLOGICAL MEDICINES EVALUATION AND RESEARCH UNIT (BMERU) GUIDELINES

Document NumberFile NameYearVersionDocument TypeDownload
9.126Reflection document on regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-220211Guideline
2.15Proprietary Names Guideline20196Guideline
2.30SAHPRA – Biosimilar Medicines Guidance20143Guideline
2.36Scheduling of Medicine Guideline20195Guideline
2.37Scheduling for Prescribing by Authorised Prescribers2019Guideline
2.39Biological Medicines Pre-Registration Consultation Meeting Guidance20201Guideline
2.60BIOLOGICAL MEDICINES STABILITY GUIDELINE20201Guideline
2.61Biological medicines amendment guideline20214Guideline
2.62SAHPRA SA NCL -COVID-19 LOT RELEASE GUIDELINE20201Guideline
6.20Pre-Registration Consultation Meeting Material Checklist20151Guideline