Steps in the evaluation process
Notification of receipt of application - These notices provide advice that a DIR licence application has been received by the OGTR and that a RARMP is in preparation.Public calls for comment - The Regulator has invited the public to provide comment on a RARMP regarding the identified risk(s) to human health and the environment and the proposed management measures.
Call for comment closed - Comments on these RARMPs have closed, the Regulator is considering submissions and a decision on the licence is imminent.
For more information about DIR applications, please contact the OGTR. DIR applications are available on request (excluding any information that the Regulator has declared to be, or is under consideration as, Confidential Commercial Information) to anyone that requests a copy (section 54 of the Act). A summary of application and, once prepared, the RARMP for each application is available on this website.
| DIR Licence Application Number | Title of Project | Notification of receipt of application | Public calls for comment on RARMP open | Call for comment closed (under consideration by the Regulator) | Is application being assessed as ‘limited and controlled’? |
|---|---|---|---|---|---|
| DIR 184 | Clinical trial with a genetically modified human adenovirus COVID-19 vaccine | 16 Mar 2021 | Yes | ||
| DIR 183 | Clinical trial with genetically modified E.coli to reduce antibiotic resistance | 08 Feb 2021 | Yes | ||
| DIR 182 | Commercial supply of recombinant COVID-19 vaccine | 02 Dec 2020 | 24 Feb 2021 | 30 Mar 2021 | No |
| DIR 181 | Clinical trial of a genetically modified Herpes virus for the treatment of cystic fibrosis | 27 Nov 2020 | Yes | ||
| DIR 179 | Clinical trial with a genetically modified Vaccinia virus vaccine to treat solid cancerous tumours | 17 Nov 2020 | 20 Jan 2021 | 24 Feb 2021 | Yes |
| DIR 178 | Commercial release of canola genetically modified for herbicide tolerance and a hybrid breeding system (MS11× RF3 and MS11 × RF3 × MON 88302) | 11 Feb 2021 | No | ||
| DIR 175 | Commercial release of canola (Brassica napus) genetically modified for herbicide tolerance and a hybrid breeding system (MS11) | 13 Oct 2020 | 28 Jan 2021 | 25 Mar 2021 | No |
View the list of DIRs.