4 OCTOBER 2012 NEW ZEALAND GAZETTE, No. 122 3479

New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Exforge HCT
Active Ingredients:

• Amlodipine besilate 13.87mg equivalent to Amlodipine 10mg
• Hydrochlorothiazide 25mg
• Valsartan 320mg
  Dosage Form: Film coated tablet

New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Gemcitabine-PF
Active Ingredient: Gemcitabine hydrochloride 11.4mg/mL equivalent to Gemcitabine 10mg/mL
Dosage Form: Concentrate for injection

New Zealand Sponsor: Agila (NZ) Pty Limited
Manufacturer: Onco Therapies Limited, Bangalore Karnataka, India
Product: GN-Gemcitabine
Active Ingredient: Gemcitabine hydrochloride 11.4mg/mL equivalent to Gemcitabine 10mg/mL
Dosage Form: Concentrate for injection

New Zealand Sponsor: Alcon New Zealand Limited
Manufacturer: Alcon Laboratories Inc, Texas, United States of America
Product: Opti-Free PureMoist
Active Ingredients:

• Myristamidopropyl dimethylamine 0.0006%w/v
• Polidronium chloride 0.001%w/v
  Dosage Form: Contact lens solution

Dated this 27th day of September 2012.

Dr DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Authorisation of a Specified Biotechnical Procedure

I, Tony Ryall, Minister of Health, pursuant to section 96C(1) of the Medicines Act 1981 (“the Act”), hereby authorise Living Cell Technologies Limited (LCT) to conduct a clinical trial involving xenotransplantation as described in its application dated the 16th day of May 2012 for protocol number LCT/PD-012, subject to the following conditions:

1. 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.

2. 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.

3. All LCT laboratory facilities are subject to inspections from Medsafe, International Accreditation New Zealand, or any person nominated by the Minister at any time during the trial, within normal working hours.

4. LCT will, when directed by Medsafe, provide a report on their compliance with any new or amended international guidelines on xenotransplantation (including those being developed by the World Health Organization), including details of how they will amend their study, if required, to bring it into compliance.

5. LCT will provide Medsafe with evidence that an accredited Health and Disability Ethics committee has considered and approved the LCT/PD-012 study protocol and associated documents.

6. LCT will provide Medsafe with evidence that the Good Manufacturing Practice certificate for its manufacturing site includes manufacture of NTCELL.

This conditional authorisation will remain in effect for the period that the clinical trial has been approved by an accredited Health and Disability Ethics committee, unless sooner varied or revoked, pursuant to section 96C(4) of the Medicines Act 1981.

Dated this 27th day of September 2012.

HON TONY RYALL, Minister of Health.

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Medicines Regulations 1983

Approved Sale of General Sales Medicines by Vending Machines (Approval No. 2012/AP016/1)

Pursuant to Regulation 59(1) of the Medicines Regulations 1983, I, Kevin Woods, Director-General of Health, approve the sales of the following general sales medicines by vending machines: