BIOLOGICAL MEDICINES EVALUATION AND RESEARCH UNIT (BMERU) GUIDELINES

Document NumberTitleCategoriesDate updatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
9.126Reflection document on regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2

2021 May

1pdfDownloadguidelinebiological-medicines-evaluation-and-research
SAHPGL-CEM-NS-03Guideline for proprietary names for medicines

2022 May

7, pdfDownloadguidelinebiological-medicines-evaluation-and-research names-and-scheduling
2.30Biosimilar Medicines Guidance

2014 Aug

3pdfDownloadguidelinebiological-medicines-evaluation-and-research
SAHPGL-CEM-NS-02Guideline to the scheduling of substances and medicines

2022 May

3, pdfDownloadguidelinebiological-medicines-evaluation-and-research names-and-scheduling
SAHPGL-CEM-NS-04Scheduling of substances for prescribing by authorised prescribers other than medical practitioners or dentists

2022 May

3, pdfDownloadguidelinebiological-medicines-evaluation-and-research names-and-scheduling
2.39Biological Medicines Pre-Registration Consultation Meeting Guidance

2020 May

1pdfDownloadguidelinebiological-medicines-evaluation-and-research
2.60Biological Medicines Stability Guideline

2020 Oct

1pdfDownloadguidelinebiological-medicines-evaluation-and-research
2.61Biological medicines amendment guideline

2021 Mar

4pdfDownloadguidelinebiological-medicines-evaluation-and-research
6.20Pre-Registration Consultation Meeting Material Checklist

2014 Jun

1pdfDownloadguidelinebiological-medicines-evaluation-and-research
2.40Multiple submissions of the same application for registration with different proprietary names

2019 May

4pdfDownloadguidelinebiological-medicines-evaluation-and-research
2.67Guidance document on quality safety and efficacy requirements for Biological Medicines

2022 Apr

1pdfDownloadguidelinebiological-medicines-evaluation-and-research
SAHPGL-PEM-BIO-01Guideline for Lot release of human vaccines

2022 Apr

2, pdfDownloadguidelinebiological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines
Communication on Medicines Registration Renewals Implementation Framework,

June 2022

1, , , pdfDownloadcommunication-to-industry guidelinebiological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines quality veterinary-medicines
SAHPGL-HPA-04Renewal of Human and Veterinary Medicines Requirements and Process

2022 Jun

1, , pdfDownloadguidelinebiological-medicines-evaluation-and-research general-ectd-human-medicines-guidelines veterinary-medicines