13 NOVEMBER 2008 NEW ZEALAND GAZETTE, No. 175

Pursuant to sections 36(2) and (4) of the Human Assisted Reproductive Technology Act 2004, copies of the guidelines are available from the Advisory Committee on Assisted Reproductive Technology (ACART), PO Box 5013, Wellington 6145. Telephone: (04) 816 2666. Email: acart@moh.govt.nz

The guidelines are available online at

www.acart.health.govt.nz

Dated at Palmerston North this 13th day of November 2008.

SYLVIA RUMBALL, Chair, Advisory Committee on Assisted Reproductive Technology.

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Guidelines Issued to Ethics Committee on Assisted Reproductive Technology

Pursuant to sections 35 and 36 of the Human Assisted Reproductive Technology Act 2004 (“the HART Act”), the Advisory Committee on Assisted Reproductive Technology (ACART) has issued Guidelines on Embryo Donation for Reproductive Purposes to the Ethics Committee on Assisted Reproductive Technology (ECART) to come into effect from 17 November 2008.

The guidelines will be available on ACART’s website www.acart.health.govt.nz from that date.

These guidelines replace the Guidelines on Embryo Donation for Reproductive Purposes of the former National Ethics Committee on Assisted Human Reproduction, which ACART issued as advice to ECART on 22 November 2007, and published in the New Zealand Gazette, 29 September 2007, No. 130, page 3375.

Dated at Palmerston North this 13th day of November 2008.

SYLVIA RUMBALL, Chair, Advisory Committee on Assisted Reproductive Technology.

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Medicines Act 1981

Amendment—Provisional Consent to the Distribution of a New Medicine

Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:

Schedule

Product: Lioresal Intrathecal
Active Ingredient: Baclofen 0.05mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Note: This consent is valid for two years from 6 November 2008.†

Product: Lioresal Intrathecal
Active Ingredient: Baclofen 2mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Note: This consent is valid for two years from 6 November 2008.†

Dated this 31st day of October 2008.

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

This notice replaces the notice published in the New Zealand Gazette*, 6 November 2008, No. 169, page 4436, in which the heading and section number details were incorrect.

†The date of publication of the original notice.

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Consent to the Distribution of New Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto:

Schedule

Product: Amlodipine
Active Ingredient: Amlodipine besilate 13.869mg equivalent to10mg amlodipine
Dosage Form: Tablet
New Zealand Sponsor: Affordable Healthcare Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Generics, Bachepalli, Andhra Pradesh, India

Product: Amlodipine
Active Ingredient: Amlodipine besilate 6.935mg equivalent to 5mg amlodipine
Dosage Form: Tablet
New Zealand Sponsor: Affordable Healthcare Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Generics, Bachepalli, Andhra Pradesh, India