NEW ZEALAND GAZETTE, No. 162

23 OCTOBER 2008

Renewal of Provisional Consent to the Distribution of a Medicine

Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicine set out in the Schedule hereto:

Schedule

Product: Coumadin
Active Ingredient: Warfarin sodium 1mg
Dosage Form: Tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Hamol Limited, Nottingham, Nottinghamshire, United Kingdom

Note: This consent is given subject to the following condition:

• Not to be marketed as substitutable for any other warfarin product as if the two products were bioequivalent.

Note: This renewed consent is valid for two years from the date of publication of this notice.

Product: Coumadin
Active Ingredient: Warfarin sodium 2mg
Dosage Form: Tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Hamol Limited, Nottingham, Nottinghamshire, United Kingdom

Note: This consent is given subject to the following condition:

• Not to be marketed as substitutable for any other warfarin product as if the two products were bioequivalent.

Note: This renewed consent is valid for two years from the date of publication of this notice.

Product: Coumadin
Active Ingredient: Warfarin sodium 5mg
Dosage Form: Tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Hamol Limited, Nottingham, Nottinghamshire, United Kingdom

Note: This consent is given subject to the following condition:

• Not to be marketed as substitutable for any other warfarin product as if the two products were bioequivalent.

Note: This renewed consent is valid for two years from the date of publication of this notice.

Dated this 16th day of October 2008.

JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Authorisation of a Specified Biotechnical Procedure

I, David Cunliffe, Minister of Health, pursuant to section 96C(1) of the Medicines Act 1981, hereby authorise Living Cell Technologies Pty Ltd (LCT) to conduct a clinical trial involving xenotransplantation as described in its application dated the 28th day of September 2007, subject to the conditions already imposed by the Northern X Regional Health and Disability Ethics Committee, and the following additional conditions:

1. Patient information and tissue samples relating to the clinical trial will be held in a patient register and tissue archive to be housed at Middlemore Hospital, to which the Ministry of Health (or such other person or organisation as the Minister may nominate for the purpose) will have unrestricted access.

2. In the event that LCT ceases trading in New Zealand, it will transfer its tissue stores and patient data relating to the trial to the Ministry of Health.

3. All trial participants must provide written consent to their patient information and tissue samples being supplied to, held by and used for the purposes of a government-administered national patient register and tissue archive.

4. LCT is, on request, to provide to the Ministry of Health (or such other person or organisation as the Minister may nominate for the purpose) any patient information and tissue samples required for the purposes of establishing and maintaining a government-administered national patient register and tissue archive.

5. LCT will at all times comply with the procedures set out in its documents entitled: "LCT Risk Management and Safety Monitoring Strategy and Operations for Xenotransplantation" and "Clinical Trial Protocol", and seek any approvals from the appropriate regulatory authorities to vary any of these procedures and protocols.

6. The operation of the trial will be overseen by an independent Data Safety Management Board, whose membership and terms of reference will be confirmed by Medsafe.

7. All serious adverse events must be reported by LCT to the relevant regulatory authorities (including Medsafe, the Northern X Regional Health and Disability Ethics Committee) immediately, and within 24 hours of becoming aware of the adverse event at the latest. Serious adverse events include those that result in death, hospitalisation or time off work, and other events identified in the study protocol, including negative changes in health status, unexplained fever, or evidence of possible infection in study participants, and reports of all positive testing for infections and negative changes in health status of the pigs being used in the study. The outcome of any investigation carried out in response to an adverse event must also be reported as soon as possible to the relevant regulatory authorities.

8. Three-monthly progress reports must be made to Medsafe, or such other person or body as the Minister may nominate.

9. A final report must be provided to Medsafe within 8 weeks of the conclusion of the trial.