11 JANUARY NEW ZEALAND GAZETTE 53

The Information Officer, Australia New Zealand Food Authority, 108 The Terrace (P.O. Box 10-559), Wellington 6036. Telephone: (04) 473 9942. Facsimile: (04) 473 9855.

The New Zealand Food Standard 2001 will come into force on the 28th day after the date of this notification.

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New Zealand (Emergency) Food Standard 2001

Section 11M of the Food Act 1981

The New Zealand (Emergency) Food Standard 2001 was issued by the Director-General of Health on 5 January 2001.

The New Zealand (Emergency) Food Standard 2001 amends the New Zealand (Mandatory) Food Standard 1997 to include as prescribed foods, bovine products and bovine derived products that may contain Bovine Spongiform Encephalopathy (BSE).

Prescribed foods are inspected at the border to ensure that they comply with New Zealand law.

The New Zealand (Emergency) Food Standard 2001 will be applied to products where the bovine component originates from specified European countries.

The list of countries is available from the Ministry of Health, including its web site – www.moh.govt.nz

The New Zealand (Emergency) Food Standard 2001 is available for inspection at the Ministry of Health, 133 Molesworth Street, Wellington.

The New Zealand (Emergency) Food Standard 2001 may be viewed on the Ministry of Health web site – www.moh.govt.nz

Copies of all New Zealand food standards, including the New Zealand (Emergency) Food Standard 2001, can be purchased from any Bennetts Government Bookshop:

• Bennetts, Commerce House, 360 Queen Street, Auckland. Telephone: (09) 377 3496. Facsimile: (09) 377 3497.
• Whitcoulls, Shop 42 Centre Place, P.O. Box 928, Hamilton. Telephone: (07) 839 6305. Facsimile: (07) 834 3520.
• Bennetts on Broadway, P.O. Box 138, Palmerston North. Telephone: (06) 358 3009. Facsimile: (06) 358 2836.
• Bennetts Government Bookshop, P.O. Box 5334, Wellington. Telephone: (04) 499 3433. Facsimile: (04) 499 3375.
• Whitcoulls Cashel Street, Private Bag, Christchurch. Telephone: (03) 379 7142. Facsimile: (03) 377 2529.
• Whitcoulls George Street, P.O. Box 1104, Dunedin. Telephone: (03) 477 8294. Facsimile: (03) 477 7869.

The New Zealand (Emergency) Food Standard 2001 comes into force on publication in the New Zealand Gazette, except for those persons who were notified directly, when it came into effect upon service of that notification.

The New Zealand (Emergency) Food Standard 2001 shall remain in force for a period of 6 months from 5 January 2001.

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Medicines Act 1981

Provisional Consent to the Distribution of a New Medicine

Pursuant to section 23 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: Rapamune

Active Ingredient(s): Sirolimus 1mg/mL

Dosage Form: Oral solution

New Zealand Sponsor: Wyeth (NZ) Limited

Manufacturer(s): Wyeth-Ayerst Laboratories, Rouses Point, New York, United States of America

Note: This consent is valid for 2 years from the date of publication of this notice.

Dated this 5th day of January 2001.

G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).

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Consent to the Distribution of Changed Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicines which were referred to the Minister of Health under the provisions of section 24 (5) of the Act and are set out in the Schedule hereto:

Schedule

Product: Intragam P

Active Ingredient(s): Immunoglobulin G 0.06g/mL

Dosage Form: Solution for injection

New Zealand Sponsor: CSL (New Zealand) Limited

Manufacturer(s): CSL Limited, Bioplasma Division, Broadmeadows, Victoria, Australia