14 DECEMBER NEW ZEALAND GAZETTE 4355

Copies of the Code or Amendments to the Code (including Amendment No. 52) can be purchased from:

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.

Amendment No. 20 of the New Zealand Food Standard 1996 will come into force on the 28th day after the date of this notification.

Health Act 1956

Notice of Publication of Annual Report

The Director-General of Health will be sending her annual report on the current state of public health in New Zealand Progress on Health Outcome Targets 1999 to the Minister of Health on 18 December 2000 in accordance with section 13C of the Health Act 1956.

It will be tabled in the House in the week of 18-22 December 2000.

Medicines Act 1981

Corrigendum

Consent to the Distribution of a New Medicine

In the notice published in the New Zealand Gazette, 23 November 2000, No. 157, page 4049, notice No. 8569, the entries in lines 10 to 19 for Clopine tablets are deleted and the following new notice is substituted:

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 medicine (Clopine) described in the Schedule hereto.

This provisional consent has effect for 2 years from 23 November 2000.

This provisional consent is subject to the following conditions:

(i) The medicine may only be prescribed by:

(a) medical practitioners who are vocationally registered under the Medical Practitioners Act 1995 in the branches of psychological medicine or psychiatry; and

(b) medical practitioners employed as registrars in psychological medicine or psychiatry who are under the supervision of persons of the kind referred to in paragraph (a) above.

(ii) Persons prescribing the medicine must comply with the requirements of the New Zealand Guidelines for the use of Atypical Anti-Psychotic Drugs (2nd Edition September 1998) and the requirements of local Hospital and Health Service Protocols for use of Clozapine.

Schedule

| Product: | Clopine |
| Active Ingredient(s): | Clozapine 25mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Douglas Pharmaceuticals Limited |
| Manufacturer(s): | Douglas Manufacturing, div. Douglas Pharmaceuticals Ltd, Central Park Drive, Lincoln, Auckland |

Dated this 6th day of December 2000.

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

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