Variation, surrender, suspension and cancellation of existing licences
Sections 68 - 72 of the Gene Technology Act 2000 (the Act) allow for a licence to be varied on either the initiative of the Gene Technology Regulator (the Regulator) or following application to the Regulator by the licence holder. The Regulator may also suspend or cancel a licence. The licence holder may also request to surrender/suspend a licence, or to have the licence transferred to another (consenting) party. The following information applies to cases where the licence holder has initiated the application.
Variation
A licence holder may apply for a variation to an existing GMO licence by writing to the Regulator, setting out details of the licence (i.e. identification number and title) and the nature of the variation being requested. The requested variation may not commence unless approved in writing by the Regulator. A variation will only be approved if the Regulator is satisfied that the risks can be managed and that the proposed variation is in accordance with other requirements under the legislation (section 71 of the Act).The Regulator has developed a Policy on the variation of GMO licences for the guidance of licence holders.
Policy on the variation of GMO licences - posted 20 August 2008 (RTF 233 KB)
Policy on the variation of GMO licences - posted 20 August 2008 (PDF 72 KB)
The Regulator has 90 working days from receipt of an application for variation to vary, or refuse to vary, a licence.
Variations are assessed on a case-by-case basis and the relevant Risk Assessment and Risk Management Plans (RARMPs) are considered.
If a variation is approved the Regulator will modify the licence conditions to reflect the changes. For DIR variations, consultation with relevant agencies and authorities may be undertaken.
Transfer
The licence holder and another organisation to which the licence is to be transferred (transferee) must apply in writing to the Regulator. The Regulator must be satisfied that the transferee is a suitable person to hold the licence (section 70 of the Act).Surrender
The licence may be surrendered, with the consent of the Regulator, by the licence holder once the dealings have ceased, or if another licence covers the dealings with the GMOs.Suspension
A licence holder may, with the consent of the Regulator, suspend a licence. Any person or organisation contemplating a suspension of a licence should apply in writing to the Regulator seeking consent to the suspension.In such cases, the application must provide to the Regulator reasons for the suspension.
Policy on Transfers, Surrenders or Suspensions of Licences (RTF 63 KB)
Policy on Transfers, Surrenders or Suspensions of Licences (PDF 55 KB)Top of page
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