Notice Title

Renewal of Provisional Consent to the Distribution of Medicines

Publication Date
30 Jun 2026

Tags

Medicines Act Provisional consent to the distribution of new medicines Health

Notice Number

2026-sl3650
Title
View PDF
File Type and Size
PDF (41 KB)

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: Clopine
Active Ingredient: Clozapine 25mg
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 (i.e. psychiatrists).
  • Medical practitioners or nurse practitioners, who are under the supervision of the persons referred to above.
  • Medical officers who are in the employment of a Te Whatu Ora, 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.

Note: This renewed consent is valid for two years from 10 July 2026.
 
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 (i.e. psychiatrists).
  • Medical practitioners or nurse practitioners, who are under the supervision of the persons referred to above.
  • Medical officers who are in the employment of a Te Whatu Ora, 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.

Note: This renewed consent is valid for two years from 10 July 2026.
 
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 (i.e. psychiatrists).
  • Medical practitioners or nurse practitioners, who are under the supervision of the persons referred to above.
  • Medical officers who are in the employment of a Te Whatu Ora, 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.

Note: This renewed consent is valid for two years from 10 July 2026.
 
Product: Clopine
Active Ingredient: Clozapine 200mg
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 (i.e. psychiatrists).
  • Medical practitioners or nurse practitioners, who are under the supervision of the persons referred to above. · Medical officers who are in the employment of a Te Whatu Ora, 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.

Note: This renewed consent is valid for two years from 10 July 2026.
   
Product: Clozaril
Active Ingredient: Clozapine 25mg
Dosage Form: Tablet
New Zealand Sponsor: Viatris Limited
Manufacturer: Madaus GmbH, Troisdorf, Germany

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 (i.e. psychiatrists).
  • Medical practitioners or nurse practitioners, who are under the supervision of the persons referred to above.
  • Medical officers who are in the employment of a Te Whatu Ora, 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.

Note: This renewed consent is valid for two years from 10 July 2026.
 
Product: Clozaril
Active Ingredient: Clozapine 100mg
Dosage Form: Tablet
New Zealand Sponsor: Viatris Limited
Manufacturer: Madaus GmbH, Troisdorf, Germany

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 (i.e. psychiatrists).
  • Medical practitioners or nurse practitioners, who are under the supervision of the persons referred to above.
  • Medical officers who are in the employment of a Te Whatu Ora, 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.

Note: This renewed consent is valid for two years from 10 July 2026.
 
Product: Oxycodone Hydrochloride Tablets, USP (Immediate Release)
Active Ingredient: Oxycodone hydrochloride 5mg
Dosage Form: Tablet
New Zealand Sponsor: Wellmed.NZ Limited
Manufacturer(s): Amneal Pharmaceuticals of New York LLC, New York, United States of America

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

  • The medicine may only be marketed or distributed when no other oxycodone hydrochloride immediate-release oral dosage form medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet sole tender obligations.
Note: This renewed consent is valid for two years from 12 July 2026.
 
Product: Oxycodone Hydrochloride Tablets, USP (Immediate Release)
Active Ingredient: Oxycodone hydrochloride 10mg
Dosage Form: Tablet
New Zealand Sponsor: Wellmed.NZ Limited
Manufacturer: Amneal Pharmaceuticals of New York LLC, New York, United States of America

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

  • The medicine may only be marketed or distributed when no other oxycodone hydrochloride immediate-release oral dosage form medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet sole tender obligations.
Note: This renewed consent is valid for two years from 12 July 2026.
 
Product: Oxycodone Hydrochloride Tablets, USP (Immediate Release)
Active Ingredient: Oxycodone hydrochloride 20mg
Dosage Form: Tablet
New Zealand Sponsor: Wellmed.NZ Limited
Manufacturer: Amneal Pharmaceuticals of New York LLC, New York, United States of America

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

  • The medicine may only be marketed or distributed when no other oxycodone hydrochloride immediate-release oral dosage form medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet sole tender obligations.
Note: This renewed consent is valid for two years from 12 July 2026.


Dated this 30th day of June 2026.

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