✨ Medicinal Product Consents




30 AUGUST 2012 NEW ZEALAND GAZETTE, No. 106 3077

  • 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.

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

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

  3. 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 renewed consent is valid for two years from 3 June 2012.

Product: Clopine
Active Ingredient: Clozapine 50mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Douglas Manufacturing Limited, Auckland, New Zealand

Note: This consent is given subject to the following conditions:

  1. The medicine may only be prescribed by:

    • 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.
    • Medical practitioners employed as registrars in the branch of psychiatry who are under the supervision of the persons referred to above.
    • 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 renewed consent is valid for two years from 3 June 2012.

Product: Clopine
Active Ingredient: Clozapine 100mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Douglas Manufacturing Limited, Auckland, New Zealand

Note: This consent is given subject to the following conditions:

  1. The medicine may only be prescribed by:
    • 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.
    • Medical practitioners employed as registrars in the branch of psychiatry who are under the supervision of the persons referred to above.
    • 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.


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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2012, No 106





✨ LLM interpretation of page content

πŸ₯ Renewed Consent for Clopine (Clozapine 50mg Tablet)

πŸ₯ Health & Social Welfare
Medicine, Consent, Clozapine, Prescription, Conditions

πŸ₯ Renewed Consent for Clopine (Clozapine 100mg Tablet)

πŸ₯ Health & Social Welfare
Medicine, Consent, Clozapine, Prescription, Conditions