Renewal of Provisional Consent to the Distribution of a New Medicine Pursuant to section 23 of the Medicines Act 1981, I provisionally consent to the sale, supply, or use in New Zealand of the new medicine (Clozaril) described in the Schedule hereto. This provisional consent has effect for 2 years from 4 February 1999. This provisional consent is subject to the following conditions: (i) Clozapine 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 Clozapine 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 Name and Strength Form Name and Address of Manufacturer Proprietary Name(if any) Clozapine 25 mg, 100 mg Tablet Novartis Pharma AG., Basle, Switzerland Clozaril Dated at Wellington this 31st day of January 1999. G. R. BOYD, Chief Advisor, Regulation and Safety, pursuant to delegation given by the Minister of Health on the 20th day of February 1997.