I, Tony Ryall, Minister of Health, pursuant to section 96C(4) of the Medicines Act 1981 ("the Act"), hereby vary the conditional authorisation, issued under section 96C(1)
of the Act to Living Cell Technologies Limited (LCT) and dated the 22nd day of June 2009*, to conduct a clinical trial involving xenotransplantation.
That authorisation is hereby varied in the following respects:
1. The protocol is amended as follows:
1.1 LCT is allowed to increase the number of participants in the study to 14.
1.2 LCT is allowed to create a fourth treatment arm where four participants are administered 5,000 IEQ/kg.
1.3 LCT is allowed to transfer two current participants who have yet to receive any treatment, from the third treatment arm into the fourth treatment arm.
2. Condition added:
2.1 LCT will, prior to implementing the amended protocol, provide Medsafe with evidence that
the Northern X Regional Ethics committee has considered and approved LCT’s proposed amendments contained in its application to Medsafe dated 15 November 2010.
All previous conditions instituted in the authorisation issued to LCT and published in the New Zealand Gazette dated
25 June 2009* remain in effect for the period that the clinical trial has been approved by the Northern X Regional Ethics Committee, unless sooner varied or revoked, pursuant to section 96C(4) of the Act.
Dated this 8th day of December 2010.
HON TONY RYALL, Minister of Health.
*New Zealand Gazette, 25 June 2009, No. 94, page 2111