30 AUGUST 2012 NEW ZEALAND GAZETTE, No. 106 3079

• Medical Officers of special scale who:

  • work solely in the field of psychiatry;
  • are in the employment of a District Health Board; and
  • are under the supervision of persons who are registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 who are certified by the Medical Council of New Zealand as competent in the scope of practice of psychiatry.

• Registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 who are registered with the Medical Council of New Zealand within the vocational scope of practice of general practice. The general practitioner must be continuing the prescribing of clozapine for a specific patient whose illness is well-controlled in collaboration, or following consultation, with a Community Mental Health Team.

2. Persons prescribing the medicine must comply with appropriate local treatment guidelines.

3. The medicine must be dispensed in accordance with appropriate local dispensing guidelines.

4. Sale or marketing of this medicine may only occur if:

• the sponsor has an appropriate blood monitoring and patient record database in place; and
• the sponsor creates or participates in a central "red flag" database identifying patients who have previously been prescribed clozapine and who developed adverse drug reactions, which mean further use is contraindicated.

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

Dated this 23rd day of August 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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Renewal of Provisional Consent to the Distribution of Medicines

Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicines set out in the Schedule hereto:

Schedule

Product: Mitomycin for Injection

Active Ingredient: Mitomycin 5mg

Dosage Form: Powder for injection

New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited

Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India

Note: This renewed consent is valid for two years from 28 October 2012.

Product: Mitomycin for Injection

Active Ingredient: Mitomycin 20mg

Dosage Form: Powder for injection

New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited

Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India

Note: This renewed consent is valid for two years from 28 October 2012.

Dated this 23rd day of August 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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Consent to the Distribution of a New Medicine

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

Schedule

Product: Velcade

Active Ingredient: Bortezomib 3.5mg

Dosage Form: Powder for injection

New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited

Manufacturers: Pierre Fabre Medicament Production, Idron, France
BSP Pharmaceuticals SRL, Latina, Italy

Dated this 23rd day of August 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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