NEW ZEALAND GAZETTE, No. 73

10 JULY 2014

5. The DAA must immediately notify the Ministry in writing of any significant change to the DAA, including but not restricted to:

   • any change in ownership and/or control of the legal entity;
   • any change in management personnel;
   • any change to the Auditor Register (refer to condition 8); and
   • any change in the status of any third party accreditation the DAA may hold including evidence of such accreditation and copies of any Third Party Accreditation Audit Reports or notifications in respect of their accreditation.

6. The DAA must conduct as a minimum at least one annual:

   • internal audit that focuses on the DAA’s auditing activities undertaken pursuant to the Act, together with a compliance audit against the requirements of the DAA as set out in the Act; and
   • management review in respect of the DAA’s programmes operated pursuant to the Act.

7. The DAA shall at all times operate an internal appeals system which is documented and conveyed in writing to all clients. Auditable records of the facts and outcomes of all client appeals shall be maintained by the DAA. The DAA must provide these records to the Ministry when requested in writing by the Ministry.

8. The DAA must provide in writing, in a timely manner when requested by the Ministry, the details of the name, auditing qualifications and experience and, if relevant, the area of clinical or service competency of each auditor or technical expert approved by the DAA to undertake audits pursuant to the Act.

9. The DAA must provide all documentation to the Ministry in the form prescribed by the Ministry.

10. The DAA must hold third party accreditation with a Ministry approved third party accreditation body.

11. The DAA must notify the Ministry of any intent to audit district health boards’ provision of hospital care services (as defined in section 4(1) of the Act), that are:

    • children’s health services;
    • geriatric services;
    • maternity services;
    • medical services;
    • mental health services;
    • surgical services;

    And satisfy the Ministry as per section 33(b) of the Act that it has:

    (i) the technical expertise to audit the provision of services of that kind; and
    (ii) effective systems in place for auditing the provision of services of that kind.

Dated at Wellington this 7th day of July 2014.

DR DON MACKIE, Chief Medical Officer.

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Health Practitioners Competence Assurance Act 2003

Appointment to the Medical Council of New Zealand

Pursuant to section 120 of the Health Practitioners Competence Assurance Act 2003, the Minister of Health appoints

Dr Tailulu (Lu’isa) Fonua-Faeamani

as a health practitioner member of the Medical Council of New Zealand for a one-year term of office commencing on the date of this notification.

Dated at Wellington this 3rd day of July 2014.

HON TONY RYALL, Minister of Health.

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Medicines Act 1981

Consent to the Distribution of New Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto:

Schedule

Product: Antiseptic Soothing Cream

Active Ingredients:

• Bufexamac 50mg/g
• Chlorhexidine gluconate 1mg/g
• Lidocaine hydrochloride 10mg/g

Dosage Form: Topical cream

New Zealand Sponsor: Multichem NZ Limited

Manufacturer: Cipla Limited, Goa, India

Product: Cortimopt

Active Ingredients:

• Dorzolamide hydrochloride 22.26mg/mL equivalent to Dorzolamide 20 mg/mL
• Timolol maleate 6.83mg/mL equivalent to Timolol 5 mg/mL

Dosage Form: Eye drops, solution

New Zealand Sponsor: Mylan New Zealand Limited

Manufacturer: Wintac Limited, Karnataka, India