Because dealings with viral vectors can be classified in the DNIR, NLRD and Exempt categories, the Regulator has developed guidance on the classification of contained dealings with viral vectors.

As of 8 October 2019, the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 amend the Commonwealth Gene Technology Regulations 2001 (the Regulations). This has changed the way some dealings with viral vectors are classified. These changes will be adopted in the gene technology legislation of States and Territories at different times, and organisations operating under those laws (e.g. state agencies of those jurisdictions) must continue to follow the earlier legislation until this has occurred. Therefore, guidance is provided below on their classification both before and after this change. For further information on the amendments, see the 2019 Amendment to the Regulations page.

Guidance on classification of contained dealings with viral vectors – effective 2011 (PDF 235 KB)
Guidance on classification of contained dealings with viral vectors – effective 2011 (DOCX 97 KB)

Guidance on classification of contained dealings with viral vectors – effective October 2019 (PDF 264 KB)
Guidance on classification of contained dealings with viral vectors – effective October 2019 (DOCX 53 KB)

Guidance for IBCs assessing NLRDs involving retroviral (including lentiviral) vectors [HTML]

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