Health and Food Notices




NEW ZEALAND GAZETTE, No. 58 — 23 JUNE 2016

or

a medical practitioner who is registered by the Medical Council of New Zealand in a general scope of
practice provided the medical practitioner is prescribing clozapine for a patient whose illness is being
well controlled by clozapine and the prescribing decision is taken in collaboration with, 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.

Also note: This renewed consent is valid for two years from 10 July 2016.

Product: Clozaril
Active Ingredient: Clozapine 100mg
Dosage Form: Tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Novartis Pharmaceuticals UK Limited, Horsham, United Kingdom
Novartis Saglik ve Gida Urunlei Sanayi ve Ticaret AS, Istanbul, Turkey

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

  1. The medicine may only be prescribed by:

a medical practitioner who is vocationally registered by the Medical Council of New Zealand in the scope
of practice of psychiatry (“psychiatrist”);

a medical practitioner or nurse practitioner who is prescribing under the supervision of a psychiatrist;

or

a medical practitioner who is registered by the Medical Council of New Zealand in a general scope of
practice provided the medical practitioner is prescribing clozapine for a patient whose illness is being
well controlled by clozapine and the prescribing decision is taken in collaboration with, 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.

Also note: This renewed consent is valid for two years from 10 July 2016.

Dated this 16th day of June 2016.

CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister
of Health on 11 September 2013).

2016-go3524


Notice Under the Food Act 2014 (Notice No. MPI 636)

Pursuant to section 398(2) of the Food Act 2014, notice is given that the New Zealand (Australia New Zealand
Food Standards Code) Food Standards 2002, Amendment No. 68, was issued by the Minister for Food Safety on
7 June 2016 and came into force on that date.

A copy of this food standard can be inspected free of charge at, or purchased from the office of, the Ministry for
Primary Industries, Pastoral House, 25 The Terrace (PO Box 2526), Wellington.

It can also be viewed at
www.foodsafety.govt.nz/elibrary/industry/zealand-australia-zealand-food-standards/amendments/index.htm

Dated at Wellington this 17th day of June 2016.

KAREN ADAIR, Director Food and Regulatory Policy, Policy and Trade, Ministry for Primary Industries.

2016-go3534

41



Next Page →



Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2016, No 58





✨ LLM interpretation of page content

🏥 Renewal of Provisional Consent to the Distribution of Medicines (continued from previous page)

🏥 Health & Social Welfare
16 June 2016
Medicines Act, Provisional Consent, Health Regulation, Clozapine, Clozaril
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health

🌾 Notice Under the Food Act 2014

🌾 Primary Industries & Resources
17 June 2016
Food Act, Food Standards, Amendment, Food Safety
  • KAREN ADAIR, Director Food and Regulatory Policy, Policy and Trade, Ministry for Primary Industries